[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-gliosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-gliosarcoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,70,94,118,144],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100438637","phase-1-phase-i-cb-nk-tgf-r2-nr3c1--in-rgbm-100438637",false,"NCT04991870","Phase I CB-NK-TGF-ßR2-\u002FNR3C1- in rGBM","A Phase I Clinical Trial With a Window-of-Opportunity Component of Engineered NK Cells Containing Deleted TGF-ßR2 and NR3C1 in Recurrent Grade 4 Astrocytoma (Glioblastoma)","Inclusion Criteria\n\n1. Signed and dated informed consent.\n2. Male or female participants aged ≥ 12 years on the day of signing informed consent.\n3. Has histologically confirmed supratentorial World Health Organization grade 4 recurrent astrocytoma to include recurrent IDH WT glioblastoma or gliosarcoma and recurrent IDHmutant grade 4 astrocytoma, and recurrent gliosarcoma with any prior number of recurrences, and who have received prior radiation and temozolomide therapy. Participants will be eligible if the original histology was lower-grade glioma grade 2 or 3 and a subsequent histological diagnosis of recurrent glioblastoma or IDH-mutant grade 4 astrocytoma is made.\n4. Karnofsky Performance Score (KPS) of \\>70 at trial entry. Lansky \\>70 at trial entry for patients less than 16.\n5. Must be at least 12 weeks from receiving conformal radiation, unless RANO criteria for early progression are met.\n6. A baseline brain MRI with Advance Brain Tumor Imaging (ABTI) must be obtained no more than 30 days prior to study registration\n7. Patients having undergone recent surgery are eligible so long as they are at least 3 weeks from resection or at least 1 week from stereotactic biopsy and recovered from any operative or perioperative complications.\n8. Adequate hematological function defined by white blood cell (WBC) count ≥ 3 x 10°9\u002FL with absolute neutrophil count (ANC) ≥ 1.5 x 10°9\u002FL, lymphocyte count ≥ 0.5 x 10°9\u002FL, platelet count ≥ 100 x 10°\u002FL, and Hgb ≥ 9 g\u002F dL (in absence of blood transfusion).\n9. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 x ULN, an AST level ≤ 2.5 x ULN, and an ALT level ≤ 2.5 x ULN, and INR ≤ 1.5 10. Adequate renal function defined creatinine ≥ 1.5 X upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL\u002Fmin for participant with creatinine levels \\> 1.5 X institutional ULN\n\n11\\. Female participant of childbearing potential should have a negative serum pregnancy test within 14 days (+\u002F-2 working days) of study registration.\n\n12\\. Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study and for 3 months after the last dose of study therapy. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n\n13\\. Male participants should agree to use 2 methods of highly effective contraception starting with the first dose of study therapy and for 3 months after the last dose of study therapy.\n\n14\\. For the surgical expansion group (Group 2): there must be at least 1 cm2 of contrast-enhancing disease that is considered resectable by the neurosurgeon.\n\nExclusion Criteria\n\n1. Has received prior therapy with Gliadel or bevacizumab.\n2. Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery.\n3. Is currently participating in or has participated in a study of cancer directed investigational agent or using an investigational device within 4 weeks since last dose of agent administration or device use, or is planning to continue or start treatment with Optune® during participation in this trial.\n4. Has known severe hypersensitivity to monoclonal antibodies, any history of anaphylaxis, or recent, within 5 months, history of uncontrolled asthma.\n5. Has a known history of Human Immunodeficiency Virus (HIV) (positive HIV 1\u002F2 antibodies); HTLV1 and\u002For HTLV2; active Hepatitis B (e.g., HbsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected). Patients with prior HBV vaccination (anti-HBs positive, HbsAg negative, anti-HBc negative) will NOT be excluded.\n6. Has a diagnosis of immunodeficiency or is receiving any immunosuppressive therapy within 7 days prior to study registration.\n7. Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 0.\n\n   1. Note: Participants with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n   2. Note: If participant received major surgery (other than craniotomy), they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n8. Has had prior radiation therapy less than 12 weeks prior to study registration, unless RANO criteria for early progression are met.\n9. Has had prior therapy with any antibody\u002Fdrug targeting T cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody within the last three months prior to study registration -.\n10. Has a known additional malignancy that is progressing or requires active treatment.\n\n    Exceptions include but are not limited to basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. Any exceptions must be discussed with the protocol PI.\n11. Has known gliomatous cerebri, extracranial disease, or tumor localized primarily to the brainstem or spinal cord.\n12. Brain midline shift greater than 0.5 cm or pending herniation seen on baseline MRI ABTI.\n13. Tumors larger than 5 cm at greatest diameter\n14. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Participants with vitiligo or resolved childhood asthma\u002Fatopy would be an exception to this rule. Participants that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.\n15. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.\n16. Has an active infection requiring systemic therapy or that in the opinion of the PI may interfere with the participant's participation, assessment of experimental treatment toxicity or increase the participant's risk of side effects.\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate in the opinion of the treating investigator.\n18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n19. Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit and through 3 months after last dose of the study treatment.\n20. Has received a live vaccine within 30 days prior to the first dose of trial treatment.\n21. Has a contraindication for undergoing MRIs.\n22. Has evidence of bleeding diathesis or coagulopathy.\n23. Is on full dose anticoagulants or antiplatelet therapy that cannot be held.\n24. Has significant hemorrhage on baseline MRI ABTI defined as \\>1 cm diameter of acute blood.\n25. Has received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).\n26. Has multicentric disease. Subject has multicentric GBM, defined as discrete sites of contrast enhancing disease without contiguous T2\u002FFLAIR abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2\u002FFLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted.\n\nTreatment will be up to 32 weeks in duration.\n\nThe number of cells administered will be based on gene editing efficiency. CB-NK-TGF-£\\]R2-\u002FNR3C1-cells will be administered via intraventricular injection via an Ommaya reservoir on day 0 and every 4 weeks y for up to 8 doses total in Group 1.\n\nSurgical patients in Group 2 will undergo intraventricular insertion of an Ommaya (day -14 to -\n\n1). They will then undergo IT injection via the Ommaya reservoir of CB-NK-TGF-£\\]R2-\u002FNR3C1-cells on day 0. Prior to planned tumor resection to occur between days 7-14. Every 4 week intraventricular injections of CB-NK-TGF-£\\]R2-\u002FNR3C1- cells will be administered for a total of 8 intraventricular treatments.\n\nIn the setting of any surgical complications following Ommaya placement, CB-NK-TGF-£\\]R2-\u002FNR3C1- cells may be delayed and administered once the patient is deemed stable by the neurosurgeon following Ommaya placement.\n\nTreatment will continue until tumor progression or intolerable toxicity, or a maximum of 8 intraventricular treatments with CB-NK-TGF-£\\]R2-\u002FNR3C1- cells whichever occurs first.","ALL","12 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial is to find out the best dose, possible benefits and\u002For side effects of engineered natural killer (NK) cells containing deleted TGF-betaR2 and NR3C1 (cord blood \\[CB\\]-NK-TGF-betaR2-\u002FNR3C1-) in treating patients with glioblastoma that has come back (recurrent). CB-NK-TGF-betaR2-\u002FNR3C1- cells are genetically changed immune cells that may help to control the disease.",[26,27,28],"Recurrent Gliosarcoma","Recurrent Supratentorial Glioblastoma","Supratentorial Gliosarcoma","RECRUITING","2026-07-28",{"date":32,"type":33},"2026-07-30","ACTUAL",{"date":35,"type":33},"2023-04-28",{"date":37,"type":20},"2027-01-31",{"name":39,"class":40},"M.D. Anderson Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100599834","phase-1-eras-801-for-the-treatment-of-resectable-and-progressive-or-recurrent-or-elderly-newly-diagnosed-idh-wildtype-grade-iv-glioblastoma-or-gliosarcoma-with-an-egfr-amplification-or-mutation-eras801-sarg-trial-100599834","NCT07089641","ERAS-801 for the Treatment of Resectable and Progressive or Recurrent or Elderly Newly Diagnosed IDH Wildtype Grade IV Glioblastoma or Gliosarcoma With an EGFR Amplification or Mutation, ERAS801-SARG Trial","A Phase Ib Open Label Clinical Trial to Evaluate the Safety and Efficacy of ERAS-801 in Recurrent Glioblastoma or Elderly Newly Diagnosed Glioblastoma Patients With EGFR Amplification and\u002For Mutation (ERAS-801-3.0)","Inclusion Criteria:\n\n* COHORT A: Patients must be 18 years of age or older on the day of signing informed consent\n* COHORT A: Patients must have histologically proven surgically accessible World Health Organization (WHO) grade IV glioblastoma\u002Fgliosarcoma, which is progressive or recurrent following radiation therapy +\u002F- chemotherapy\n* COHORT A: Patient tumor sample must have wild type IDH with evidence of EGFR mutation\u002Famplification by Clinical Laboratory Improvement Act (CLIA)-certified laboratory assay. Patients with EGFR mutations in T790M or exon 20 will be excluded\n* COHORT A: Patients may have had no more than two prior recurrences\n* COHORT A: Patient must be able to tolerate MRIs. Pre-study enrollment MRIs must be available for central review, including at least the immediate pre-progression scan and the scan demonstrating progression. Patients must have measurable, by RANO, supratentorial contrast-enhancing progressive or recurrent high-grade glioma by MRI imaging within 28 days prior to enrollment\n* COHORT A: Patients must have recovered from severe toxicity of prior therapy. The following intervals from previous treatments are required to be eligible:\n\n  * 12 weeks from the completion of radiation\n  * 6 weeks from a nitrosourea chemotherapy\n  * 3 weeks from a non-nitrosourea chemotherapy\n  * 4 weeks from any investigational (not Food and Drug Administration \\[FDA\\]-approved) agents\n  * 4 weeks from the last treatment with bevacizumab\n  * 2 weeks from administration of a non-cytotoxic, FDA-approved agent other than bevacizumab (e.g., hydroxychloroquine, etc.)\n  * 1 week from the tumor treating fields\n* COHORT A: Patients must be undergoing surgery that is clinically indicated as determined by their care providers. Patients must be eligible for surgical resection according to the following criteria:\n\n  * Expectation that the surgeon can resect at least 500 mg of tumor from enhancing tumor and 100 mg from non-enhancing tumor (if available) with low risk of inducing neurological injury\n* COHORT A: Paraffin embedded tissue must be available from initial surgical resection at diagnosis (prior to any treatment). The following amount of tissue is requested: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 30 FFPE unstained slides (5µm thick)\n* COHORT A: Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself\u002Fherself with occasional help from others)\n* COHORT A: Absolute neutrophil count (ANC) ≥ 1000\u002FuL\n* COHORT A: Platelets ≥ 100,000\u002FuL\n* COHORT A: Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL\n\n  * Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\n* COHORT A: Creatinine ≤ 1 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 30 mL\u002Fmin for participant with creatinine levels \\> 1 x institutional ULN (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\])\n\n  * Creatinine clearance (CrCl) should be calculated per institutional standard\n* COHORT A: Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome\n* COHORT A: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x ULN\n* COHORT A: International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* COHORT A: Patients must have left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment\n* COHORT A: Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with Fridericia's formula-corrected QT interval (QTcF) =\\\u003C 450 msec\n* COHORT A: Patients must be able to provide written informed consent\n* COHORT A: Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose\n* COHORT A: Women of childbearing potential and men must agree to use adequate method of contraception for the duration of study participation and for at least 6 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after the last dose of study drug\n* COHORT A: Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, prostate, bladder or melanoma in situ. Patients with prior malignancies must be disease-free for \\> three years\n* COHORT A: Patients must be able to swallow medication by mouth\n* COHORT B: Patients must be 18 years of age or older on the day of signing informed consent\n* COHORT B: Patients must have histologically proven WHO grade 4 glioblastoma\u002Fgliosarcoma, which is progressive or recurrent following radiation therapy +\u002F- chemotherapy\n* COHORT B: Patient initial tumor sample must have wild type IDH with evidence of EGFR mutation\u002Famplification by CLIA-certified laboratory assay. Patients with EGFR mutations in T790M or exon 20 will be excluded\n* COHORT B: Patients may have had no more than two prior recurrences\n* COHORT B: Patient must be able to tolerate MRIs. Pre-study enrollment MRIs must be available for central review, including at least the immediate pre-progression scan and the scan demonstrating progression. Patients must have measurable, by RANO, supratentorial contrast-enhancing progressive or recurrent high-grade glioma by MRI imaging within 14 days prior to enrollment\n* COHORT B: Patients must have recovered from severe toxicity of prior therapy. The following intervals from previous treatments are required to be eligible:\n\n  * 12 weeks from the completion of radiation\n  * 6 weeks from a nitrosourea chemotherapy\n  * 3 weeks from a non-nitrosourea chemotherapy\n  * 4 weeks from any investigational (not FDA-approved) agents\n  * 4 weeks from the last treatment with bevacizumab\n  * 2 weeks from administration of an anti-cancer, non-cytotoxic, FDA-approved agent other than bevacizumab (e.g., hydroxychloroquine, etc.)\n  * 1 week from the tumor treating fields device(s)\n* COHORT B: Paraffin embedded tissue must be available from initial surgical resection at diagnosis. The following amount of tissue is requested: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 30 FFPE unstained slides (5um thick).\n* COHORT B: Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself\u002Fherself with occasional help from others)\n* COHORT B: Absolute neutrophil count (ANC) ≥ 1000\u002FuL\n* COHORT B: Platelets ≥ 100000\u002FuL\n* COHORT B: Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FLa\n\n  * Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\n* COHORT B: Creatinine \\\u003C 1.5 times ULN or measured or calculated creatinine clearance \\> 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 x institutional ULN (GFR can also be used in place of creatinine or CrCl)\n\n  * Creatinine clearance (CrCl) should be calculated per institutional standard.\n* COHORT B: Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome\n* COHORT B: AST (SGOT) and ALT (SGPT) ≤ 3 x ULN\n* COHORT B: International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* COHORT B: Patients must have left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment\n* COHORT B: Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with QTcF ≤ 450 msec\n* COHORT B: Patients must be able to provide written informed consent\n* COHORT B: Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose\n* COHORT B: Women of childbearing potential and men must agree to use adequate method of contraception for the duration of study participation and for at least 6 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after the last dose of study drug\n* COHORT B: Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, prostate, bladder or melanoma in situ. Patients with prior malignancies must be disease-free for \\> three years\n* COHORT B: Patients must be able to swallow medication by mouth\n* COHORT C: Patients must be ≥ 70 years of age at the time of informed consent, with a life expectancy \\> 8 weeks\n* COHORT C: Patients must have histologically proven newly diagnosed WHO grade 4 glioblastoma\u002Fgliosarcoma\n* COHORT C: Patient initial tumor sample must have wild type IDH with evidence of EGFR mutation\u002Famplification by CLIA-certified laboratory assay. Patients with EGFR mutations in T790M or exon 20 will be excluded\n* COHORT C: Patient must be able to tolerate MRIs. Pre-study enrollment MRIs must be available for central review, including the pre-surgery MRI and the immediate post-diagnostic surgery MRI. The immediate postoperative MRI is preferred but not required to occur within 96 hours of surgery. The patient must also have a baseline MRI within 14 days prior to enrollment. Craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis. Enrollment is at least 2-4 weeks from prior surgery (if time is needed to be extended, PI approval needed)\n* COHORT C: Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself\u002Fherself with occasional help from others)\n* COHORT C: Absolute neutrophil count (ANC) ≥ 1000\u002FuL\n* COHORT C: Platelets ≥ 100000\u002FuL\n* COHORT C: Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FLa\n\n  * Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\n* COHORT C: Creatinine \\\u003C 1.5 times ULN OR measured or calculated creatinine clearance \\> 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 x institutional ULN (GFR can also be used in place of creatinine or CrCl)\n\n  * Creatinine clearance (CrCl) should be calculated per institutional standard\n* COHORT C: Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome\n* COHORT C: AST (SGOT) and ALT (SGPT) ≤ 3 x ULN\n* COHORT C: International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* COHORT C: Paraffin embedded tissue must be available from initial surgical resection at diagnosis. The following amount of tissue is requested: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 30 FFPE unstained slides (5um thick)\n* COHORT C: Patients must have left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment\n* COHORT C: Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with QTcF ≤ 450 msec\n* COHORT C: Patients must be able to provide written informed consent\n* COHORT C: Men treated or enrolled on this protocol who has a partner with reproductive potential must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after the last dose of study drug\n* COHORT C: Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, prostate, bladder or melanoma in situ. Patients with prior malignancies must be disease-free for \\> three years\n* COHORT C: Patients must be able to swallow medication by mouth\n\nExclusion Criteria:\n\n* COHORT A: Participants may not be receiving any other investigational agents\n* COHORT A: Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ERAS-801 are ineligible\n* COHORT A: Participants with prior therapy with EGFR inhibitors such as EGFR kinase inhibitors or other EGFR-targeted agents that have the potential to deplete the tumor of EGFR-amplified or EGFR mutant cell populations and confound the evaluation of ERAS-801 effects on participants are ineligible. If a participant had received previous treatment with EGFR-targeted agents but tumor resection after completing this treatment still shows EGFR amplification, patient might still be eligible and should be discussed with the principal investigator (PI)\n* COHORT A: Participants on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of ERAS-801\n* COHORT A: Participants must not have evidence of significant hematologic, renal, or hepatic dysfunction\n* COHORT A: Participants must not have evidence of significant intracranial hemorrhage\n* COHORT A: Participants with clinically significant cardiovascular disease including, but not limited to:\n\n  * Myocardial infarction or unstable angina within the 6 months prior to the first dose of study drug\n  * Clinically significant cardiac arrhythmia\n  * Prolonged QTcF \\> 450 ms\n  * Uncontrolled (persistent) hypertension: systolic blood pressure \\> 180 mmHg; diastolic blood pressure \\> 100 mmHg\n  * Congestive heart failure (New York Heart Association class III-IV)\n  * Use of pacemaker\n  * Pulmonary embolism \\\u003C 30 days\n* COHORT A: Participants with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, are ineligible\n* COHORT A: Pregnant women are excluded from this study because ERAS-801 has unknown potential for teratogenic or abortifacients effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ERAS-801, breastfeeding should be discontinued if the mother is treated with ERAS-801\n* COHORT A: Participants currently using or anticipating need to use drugs, food, or herbal supplements known to be strong or moderate inducers or inhibitors of CYP3A4, CYP2C8, and\u002For CYP2D6 and P-glycoprotein (P-gp) substrates may be enrolled if they have been off the substrates for at least 10 days or 5 half-lives prior to the first dose of ERAS 801, whichever is shorter\n* COHORT A: Participants who have acute or currently active\u002Frequiring anti-viral therapy hepatic or biliary disease are ineligible (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases from the primary brain tumor, or stable chronic liver disease per investigator assessment)\n* COHORT A: Patients with gastrointestinal conditions that may affect reliable administration\u002Fabsorption of medications including difficulty swallowing\u002Funable to swallow pills; malabsorption syndrome; refractory nausea and vomiting, chronic gastrointestinal (GI) disease or previous significant bowel resection with clinically significant sequelae are ineligible\n* COHORT A: Participants receiving P-gp inhibitors are ineligible\n* COHORT A: Patients who have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial are ineligible\n* COHORT B: Participants may not be receiving any other investigational agents\n* COHORT B: Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ERAS-801 are ineligible\n* COHORT B: Participants with prior therapy with EGFR inhibitors such as EGFR kinase inhibitors or other EGFR-targeted agents that have the potential to deplete the tumor of EGFR-amplified or EGFR mutant cell populations and confound the evaluation of ERAS-801 effects on participants are ineligible. If a participant had received previous treatment with EGFR-targeted agents but tumor resection after completing this treatment still shows EGFR amplification, patient might still be eligible and should be discussed with the PI\n* COHORT B: Participants on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of ERAS-801\n* COHORT B: Participants must not have evidence of significant hematologic, renal, or hepatic dysfunction\n* COHORT B: Participants must not have evidence of significant intracranial hemorrhage\n* COHORT B: Participants with clinically significant cardiovascular disease including, but not limited to:\n\n  * Myocardial infarction or unstable angina within the 6 months prior to the first dose of study drug\n  * Clinically significant cardiac arrhythmia\n  * Prolonged QTcF\\> 450 ms\n  * Uncontrolled (persistent) hypertension: systolic blood pressure \\> 180 mmHg; diastolic blood pressure \\> 100 mmHg\n  * Congestive heart failure (New York Heart Association class III-IV)\n  * Use of pacemaker\n  * Pulmonary embolism \\\u003C 30 days\n* COHORT B: Participants with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, are ineligible\n* COHORT B: Pregnant women are excluded from this study because ERAS-801 has unknown potential for teratogenic or abortifacients effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ERAS-801, breastfeeding should be discontinued if the mother is treated with ERAS-801\n* COHORT B: Participants currently using or anticipating need to use drugs, food, or herbal supplements known to be strong or moderate inducers or inhibitors of CYP3A4, CYP2C8, and\u002For CYP2D6 and P-gp substrates may be enrolled if they have been off the substrates for at least 10 days or 5 half-lives prior to the first dose of ERAS 801, whichever is shorter\n* COHORT B: Participants who have acute or currently active\u002Frequiring anti-viral therapy hepatic or biliary disease are ineligible (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases from the primary brain tumor, or stable chronic liver disease per investigator assessment)\n* COHORT B: Patients with gastrointestinal conditions that may affect reliable administration\u002Fabsorption of medications including difficulty swallowing\u002Funable to swallow pills; malabsorption syndrome; refractory nausea and vomiting, chronic gastrointestinal (G","18 Years",{"count":51,"type":20},50,[23],"This phase Ib trial tests the safety and side effects of ERAS-801 in treating patients with isocitrate dehydrogenase (IDH) wildtype, epidermal growth factor receptor (EGFR) amplified or mutated grade IV glioblastoma or gliosarcoma that can be removed by surgery (resectable) and that is growing, spreading, or getting worse (progressive), that has come back after a period of improvement (recurrent) or that is newly diagnosed in an elderly patient. Glioblastoma is the most common brain cancer in adults and survival rates remain poor despite treatment including surgery, radiation and chemotherapy. EGFR is a protein found on the surface of some cells, to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of tumor cells, so these cells may divide excessively in the presence of epidermal growth factor. ERAS-801, an EGFR inhibitor that can penetrate the central nervous system, binds to the tumor cells that express EGFR and may help shrink or slow the growth of the tumor cells.",[55,56,57,58,26,59],"Glioblastoma","Glioblastoma, IDH-Wildtype","Gliosarcoma","Recurrent Glioblastoma, IDH-Wildtype","Resectable Glioblastoma","2026-07-16",{"date":62,"type":33},"2026-07-20",{"date":64,"type":33},"2025-07-28",{"date":66,"type":20},"2028-07-30",{"name":68,"class":40},"Jonsson Comprehensive Cancer Center",2,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":41},"100354565","phase-1-msc-dnx-2401-in-treating-patients-with-recurrent-high-grade-glioma-100354565","NCT03896568","MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma","Phase I Clinical Trial of Allogeneic Bone Marrow Human Mesenchymal Stem Cells Loaded With A Tumor Selective Oncolytic Adenovirus, DNX-2401, Administered Via Intra-Arterial Injection in Patients With Recurrent High-Grade Glioma","Inclusion Criteria:\n\nSubjects must meet the following inclusion criteria to be eligible and enroll:\n\n1. Subjects must be willing and able to provide informed consent, undergo and comply with all study assessments, and adhere to the protocol schedule.\n2. Patients with recurrent malignant GBM or gliosarcoma will be eligible. Patients with recurrent anaplastic astrocytoma with wild-type IDH-1 gene will also be eligible if there is a significant enhancing mass on MRI (≥1.0 cm in diameter with upper limit of 5 cm maximal diameter) because their prognosis\u002Fbehavior is similar to GBM. Subjects with an initial diagnosis of an IDH-mutant grade 2 or 3 astrocytoma are also eligible at recurrence if a biopsy at recurrence is determined to be IDH-mutant grade 4 astrocytoma, and there is a significant enhancing mass on MRI (≥1.0 cm in diameter with upper limit of 5 cm maximal diameter). A pathology report constitutes adequate documentation of histology for study inclusion.\n3. Patients must show unequivocal evidence for tumor recurrence or progression by MRI scan after failing prior surgical resection, biopsy, chemotherapy or radiation. A baseline MRI must be performed within 24 days prior to registration. Biopsy is encouraged at the time of recurrence if it is unclear that there is recurrent tumor. However, biopsy is not required if the practicing physician thinks that there is adequate radiographic and clinical evidence for recurrence.\n4. Male or female patients ≥ 18 years of age.\n5. Patients must be able to undergo endovascular treatment based on Doppler studies showing ICA that is less than 50% occluded.\n6. For patients undergoing resection for biological endpoints, tumors must be surgically resectable at the time of baseline evaluation and craniotomy for tumor resection is indicated as part of their standard medical care.\n7. Tumors must be ≥1.0 cm in diameter with upper limit of 5 cm maximal diameter.\n8. Patients must have a Karnofsky performance score ≥ 70.\n9. Patients must have a life expectancy of at least 16 weeks.\n10. Patients must have adequate bone marrow function (absolute granulocyte count \\> 1,500 and platelet count of \\> 75,000), adequate liver function (SGPT and SGOT and bilirubin \\\u003C 2 times institutional normal ranges), and adequate renal function (creatinine \\\u003C 2.0 times institutional normal) prior to starting therapy.\n11. Prothrombin time\u002Finternational normalized ratio (PT\u002FINR) or partial thromboplastin time (PTT) ≤ 1.5x ULN.\n12. Subjects who have received the following chemotherapies must have completed them within the following time periods prior to Baseline\u002FDay 0 of hMSC-DNX2401 delivery with recovery from any drug-related toxic effects to Grade 1, or less, severity:\n\n    * Four weeks from cytotoxic agents (3 weeks from procarbazine or Temozolomide, 2 weeks from vincristine)\n    * 6 weeks from nitrosoureas (CCNU, BCNU)\n    * Four weeks from any targeted investigational agent\n    * One week from non-cytotoxic agents\n13. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender.\n14. No exclusion to this study will be based on race. Minorities will actively be recruited to participate. The malignant glioma patient population treated at MDACC over the past year is as follows:\n\n    * American Indian or Alaskan Native - 0\n    * Asian or Pacific Islander - \\\u003C2%\n    * Black, not of Hispanic Origin - 3%\n    * Hispanic - 6%\n    * White, not of Hispanic Origin - 88%\n    * Other or Unknown - 2%\n    * Total - 100%\n15. Patients must be 8 weeks from radiotherapy to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, or 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is outside the primary radiation field (beyond 80% isodose line). However, if a biopsy is undertaken prior to these times and this biopsy documents histological evidence for recurrent disease, then patients will be eligible regardless of the time after radiation.\n16. Patients must be willing to forego other cytotoxic and non-cytotoxic drug or radiation therapy against the tumor while enrolled in the study.\n17. Women of childbearing potential must have a negative urine or serum pregnancy test at screening.\n18. Subjects and their partners must be willing to use effective birth control during the study and for up to 6 months following administration of hMSC-DNX2401. Birth control that is acceptable to use in this study:\n\n    * Using twice the normal protection of birth control (i.e., double-barrier) by using a condom AND spermicidal jelly or foam, or a diaphragm AND spermicidal jelly or foam. A spermicidal jelly or foam must be used in addition to a barrier method (e.g., condom or diaphragm)\n    * Birth control pills (\"The Pill\")\n    * Depot or injectable birth control\n    * IUD (Intrauterine Device)\n    * Birth Control Patch (e.g., Othro Evra®)\n    * NuvaRing®\n    * Surgical sterilization (i.e., tubal ligation or hysterectomy for women or vasectomy for men)\n\nExclusion Criteria:\n\n1. Histology other than GBM, gliosarcoma, IDH wild-type astrocytoma grade III or IDH-mutant astrocytoma grade 4.\n2. Tumor foci detected below the tentorium or beyond the cranial vault.\n3. Tumor within the posterior fossa.\n4. Tumor with leptomeningeal spread.\n5. Difficulty in obtaining vascular access for percutaneous procedure.\n6. Ipsilateral carotid stenosis (\\>50%, by Doppler studies).\n7. Thrombophilias or primary hematological diseases.\n8. Transfusions or medications (G-CSF) to treat pancytopenia or other hematological conditions \\\u003C 28 days prior to Baseline\u002FDay 0\u002FhMSC-DNX2401 administration.\n9. Biologic\u002Fimmunotherapy within 2 weeks of baseline.\n10. Clinical or laboratory evidence of inflammatory and\u002For autoimmune disorders.\n11. Any contraindication for undergoing MRI such as: individuals with pacemakers, epicardial pacer wires, infusion pumps, surgical and\u002For aneurysm clips, shrapnel, metal prosthesis, implants with potential magnetic properties, metallic bodies in the eyes, etc. In addition, subjects must present with tumor that is evaluable by MRI.\n12. Pregnant or nursing females.\n13. Evidence of active uncontrolled infection or unstable or severe intercurrent medical conditions. All subjects must be afebrile (i.e., \\\u003C38.0° Celsius \\[C\\]).\n14. Any medical condition that precludes surgery or endovascular treatment\n15. Alcoholism (dependency), alcohol or substance abuse within twelve (12) months prior to screening that has caused health consequences.\n16. Immunocompromised subjects or those with autoimmune conditions, active hepatitis (Liver function tests \\> 2x normal) or human immunodeficiency virus (HIV) seropositivity.\n17. Evidence of bleeding diathesis or use of anticoagulant medication or any medication that may increase the risk of bleeding that cannot be stopped prior to surgery. If the medication can be discontinued prior to DNX-2401 injection then the subject may be eligible following consultation with the Study Chair. Low weight heparin and Lovenox (enoxaparin) administered on a temporary limited basis for post procedure DVT prophylaxis is permitted.\n18. History or current diagnosis of any medical or psychological condition that in the Investigator's opinion might interfere with the subject's ability to participate or inability to obtain informed consent because of psychiatric or complicating medical problems.\n19. Encephalitis, multiple sclerosis or other central nervous system (CNS) infection or primary CNS disease that would interfere with subject evaluation.\n20. Subjects with known Li-Fraumini Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.\n21. Subjects with significant systemic or major illnesses including but not limited to: congestive heart failure, ischemic heart disease, cerebrovascular disease (history of strokes or TIAs in large vessel or small vessel distribution), kidney disease or renal failure, active liver disease, organ transplantation, or significant psychiatric disorder.\n22. Enrollment in a concomitant therapeutic clinical study.\n23. Any condition that prevents compliance with the protocol or adherence to therapy.\n24. For patients enrolled in the biological endpoint phase of the study, patients will be excluded if in the assessment of the surgeon, after resecting the tumor, there is high likelihood of injecting BM-hMSC-DNX2401 into the ventricles.",{"count":78,"type":20},36,[23],"This phase I trial studies best dose and side effects of oncolytic adenovirus DNX-2401 in treating patients with high-grade glioma that has come back (recurrent). Oncolytic adenovirus DNX-2401 is made from the common cold virus that has been changed in the laboratory to make it less likely to cause an infection (such as a cold). The virus is also changed to target brain cancer cells and attack them.",[82,83,84,26,85],"IDH1 wt Allele","Recurrent Anaplastic Astrocytoma","Recurrent Glioblastoma","Recurrent Malignant Glioma","2026-07-14",{"date":88,"type":33},"2026-07-15",{"date":90,"type":33},"2019-02-12",{"date":92,"type":20},"2027-09-30",{"name":39,"class":40},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100625417","phase-1-testing-the-combination-of-anti-cancer-drugs-actimab-a-and-cemiplimab-regn2810-to-improve-outcomes-for-patients-with-recurrent-glioblastoma-100625417","NCT07422363","Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma","A Phase I Trial of 225Ac-anti-CD33 and PD1-Inhibitor in Recurrent Glioblastoma","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed glioblastoma isocitrate dehydrogenase wild type (IDH-WT) World Health Organization (WHO) grade 4 inclusive of gliosarcoma (Louis et al., 2021)\n\n  * Note: Isocitrate dehydrogenase (IDH) status confirmed by immunohistochemistry (IHC) for IDH1 R132H + next-generation sequencing (NGS) for IDH1 and IDH2 hotspots\n* Evidence of recurrent disease (RD) that is measurable (1 x 1cm) at first or second relapse demonstrated by disease progression using Response Assessment in Neuro-Oncology 2.0 (RANO 2.0) criteria, unless the recurrence is outside the radiation field or has been histologically documented\n* Tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) methylation status must be available from any prior GBM tumor specimen; results of routinely used methods for MGMT methylation testing (e.g., mutagenically separated polymerase chain reaction \\[MSPCR\\] or quantitative polymerase chain reaction \\[PCR\\] are acceptable)\n* Previous first-line treatment with at least radiotherapy (prior dose ≥ 40 gray \\[Gy\\])\n\n  * Note: Prior temozolomide, prior tumor-treatment fields and\u002For Gliadel wafer (if placed at initial tumor resection) are allowed, but none of these are required\n* Last radiation ≥ 6 months (182 days) prior to enrollment if received ≥ 60 Gy or ≥ 3 months (84 days) if received \\\u003C 60 Gy to limit the risk of radiation necrosis\n* No previous treatment with anti PD1, PDL1, CTLA-4, or other immune checkpoint inhibitors\n* No tumor-directed therapy for most recent progression\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of Actimab-A in combination with cemiplimab (REGN2810) in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Hemoglobin ≥ 9 g\u002FdL\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within six (6) months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* The effects of Actimab-A and cemiplimab (REGN2810) on the developing human fetus are unknown. For this reason and because anti-PD-1 agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for at least six (6) months after completion of Actimab-A. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and six (6) months after completion of Actimab-A and cemiplimab (REGN2810) administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives (LAR) may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered to grade 0 or 1 or pre-treatment baseline from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* Presence of extracranial metastatic or leptomeningeal disease\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Actimab-A and cemiplimab (REGN2810)\n* Patients being treated with systemic immunostimulatory agents (including, but not limited to, interferon \\[IFN\\]-α or interleukin \\[IL\\]-2) within four (4) weeks prior to cycle 1 day 1. The study principal investigator (PI) must be consulted if a patient was being treated with any antibody within four (4) half-lives of said antibody\n\nTreatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha \\[TNF-α\\] agents) within two (2) weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n* Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study\n* Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study\n\n  * Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n  * Pregnant women are excluded from this study because cemiplimab (REGN2810) is an anti-PD-1 agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cemiplimab (REGN2810), breastfeeding should be discontinued if the mother is treated with cemiplimab (REGN2810). These potential risks also apply to Actimab-A\n  * Early disease progression prior to three (3) months from the completion of radiotherapy\n  * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy defined as dexamethasone \\> 2 mg\u002Fday or bioequivalent for at least three (3) consecutive days within two (2) weeks of start of study drug\n  * Has active autoimmune disease that has required systemic treatment in the past two (2) years\n  * Prior administration of a radiopharmaceutical unless 10 or more effective half-lives have elapsed before injection of Actimab-A (Ac225-lintuzumab)\n  * Previous treatment with bevacizumab for the treatment of glioblastoma with therapeutic intent, or with bevacizumab as supportive therapy (e.g., edema reduction) within six (6) weeks (42 days) of initiation of study treatment. This is approximately two (2) half-lives which is justified based on median time to rebound tumor progression following bevacizumab discontinuation (6.1 weeks), median time to clinical deterioration following bevacizumab discontinuation after disease progression from multiple studies indicating that washout periods longer than eight (8) weeks are unlikely to be tolerated, and perioperative outcome data after neoadjuvant bevacizumab demonstrating relative safety of surgical intervention at least four (4) weeks after bevacizumab discontinuation (Sener et al., 2024)\n  * Patients who are unable to take spironolactone or eplerenone due to intolerance, allergy, drug-drug interactions, or for any other reason",{"count":102,"type":20},30,[23],"This phase I trial studies the side effects and best dose of Actimab-A when given together with cemiplimab (REGN2810) in treating patients with glioblastomas that have come back after a period of improvement (recurrent). Actimab-A consists of the monoclonal antibody lintuzumab combined with the radioactive drug actinium Ac 225. Lintuzumab specifically binds to the cell surface antigen CD33 which is found on the glioblastoma cells and delivers the actinium Ac 225. This may allow the glioblastoma to be found and treated by Actimab-A. Immunotherapy with monoclonal antibodies, such as cemiplimab (REGN2810), may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving Actimab-A with cemiplimab (REGN2810) may be safe, tolerable and\u002For effective in treating recurrent glioblastoma.",[58,26,106],"Recurrent WHO Grade 4 Glioma","NOT_YET_RECRUITING","2026-06-11",{"date":110,"type":33},"2026-06-12",{"date":112,"type":20},"2026-12-04",{"date":114,"type":20},"2027-02-28",{"name":116,"class":117},"National Cancer Institute (NCI)","NIH",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":41},"100616104","phase-2-gi-102-alone-or-with-pembrolizumab-before-surgery-for-treatment-of-recurrent-or-progressive-idh-wildtype-glioblastoma-and-idh-mutated-grade-4-astrocytoma-100616104","NCT07301268","GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma","MC230719 Window Of Opportunity Study Of GI-102 In Patients With Recurrent High-Grade Glioblastoma","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease characteristics\n\n  * Tissue-confirmed progressive or recurrent World Health Organization (WHO) grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma); and IDH mutated WHO grade 4 astrocytoma\n  * Candidates for surgical resection\n* Measurable or non-measurable disease as defined by Response Assessment in Neuro-Oncology (RANO) 2.0\n* Willing to undergo clinically indicated biopsy followed by resection of high-grade glioma at Mayo Clinic in Rochester, Minnesota (MN)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0,1, or 2 and Karnofsky performance status (KPS) ≥ 60\n\n  * NOTE: PS must be assessed (again) ≤ 7 days prior to first dose of study drug\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml\u002Fmin (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 x ULN (obtained ≤ 15 days prior to registration)\n* Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN (obtained ≤ 15 days prior to registration)\n* Amylase and lipase ≤ ULN (obtained ≤ 15 days prior to registration)\n* Left ventricular ejection fraction (LVEF) ≥ 50% (obtained ≤ 29 days prior to registration)\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Persons of childbearing potential (POCBP) or able to father a child must be willing to use adequate contraception starting with first dose through 180 days after last dose\n* Provide written informed consent\n* Willingness to provide blood specimens for correlative research\n* Willingness to provide tissue specimens for correlative research\n* Willingness to provide written informed consent for the neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and\u002For blood samples collected on this protocol\n* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait)\n* Prior treatment\n\n  * Received bevacizumab (AVASTIN) \\\u003C 30 days prior to registration\n\n    * NOTE: Bevacizumab is allowed for symptom control during the adjuvant phase of the study\n  * Increasing dexamethasone dose prior to registration\n\n    * NOTE: Patients currently on dexamethasone must be on dose ≤ 4 mg\u002Fday at time of registration\n  * Received chemotherapy \\\u003C 30 days prior to registration\n  * Received a live vaccine \\\u003C 30 days prior to registration\n* Failure to recover from any adverse events related to any of the following therapies received prior to registration:\n\n  * Major surgery \\\u003C 28 days prior to registration\n  * Radiation therapy \\\u003C 14 days prior to registration\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring IV antibiotics\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness\u002Fsocial situations (e.g., drug addiction) that would limit compliance with study requirements\n* Receiving any other investigational agent at the time of registration\n* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) ≤ 2 years prior to registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Concurrent known active hepatitis B (i.e., known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] reactive) AND known active hepatitis C (i.e., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] detected by polymerase chain reaction \\[PCR\\]). Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority\n\n  * NOTE: Patients with known hepatitis B OR hepatitis C may be enrolled if they meet the following criteria:\n\n    * Hepatitis B: Patients who are HBsAG positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on anti-viral therapy throughout the treatment phase of the trial and should follow local guidelines for HBV anti-viral therapy after completing study treatment\n    * Hepatitis C: Patients with history of hepatitis C infection are eligible if HCV viral load is undetectable at screening. Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration\n* Known history of active TB (Bacillus tuberculosis)\n* History of (non-infectious) pneumonitis or interstitial lung disease that required steroids, or current pneumonitis or interstitial lung disease\n* Hypersensitivity to pembrolizumab, IL-2, GI-102 or any of its excipients\n* History of allogeneic tissue\u002Fsolid organ transplant",{"count":78,"type":20},[127],"PHASE2","This phase II trial compares the effect of GI-102 alone and in combination with pembrolizumab given before surgery in treating patients with IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). Glioblastoma is the most common and the most aggressive primary brain tumor in adults. Current standard of care includes surgical resection, radiation and chemotherapy. Treatment is often given before surgery (neoadjuvant therapy) to shrink the tumor and make it easier to remove. Treatment with GI-102, a bispecific fusion protein, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving GI-102 alone and in combination with pembrolizumab between neoadjuvant therapy and surgery may be safe, tolerable, and effective in treating patients with recurrent or progressive IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma.",[56,130,131,132,133,58,26,134,59],"Progressive Astrocytoma, IDH-Mutant, Grade 4","Progressive Glioblastoma","Progressive Gliosarcoma","Recurrent Astrocytoma, IDH-Mutant, Grade 4","Resectable Astrocytoma","2026-04-02",{"date":137,"type":33},"2026-04-08",{"date":139,"type":33},"2026-04-01",{"date":141,"type":20},"2034-04-30",{"name":143,"class":40},"Mayo Clinic",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":21,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":41},"100475057","phase-2-efineptakin-alfa-and-pembrolizumab-for-the-treatment-of-recurrent-glioblastoma-100475057","NCT05465954","Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma","Efficacy and Safety Study of Neoadjuvant Efineptakin Alfa (NT-I7) and Pembrolizumab in Recurrent Glioblastoma","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Disease characteristics:\n\n  * Tissue-confirmed progressive or recurrent World Health Organization (WHO) Grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma)\n  * Previously treated with maximum feasible resection or biopsy, radiation, and temozolomide\n* Have an enhancing mass on magnetic resonance imaging (MRI) amenable to resection or biopsy of the tumor (as determined by the neurosurgeon pre-operatively) and histological diagnosis of glioblastoma from a prior biopsy or surgery\n* Willing to undergo clinically indicated biopsy and\u002For resection of their glioblastoma at Mayo Clinic in Rochester, Minnesota (MN).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 and Karnofsky Performance Scale (KPS) \\>= 70 NOTE: PS must be assessed (again) within 7 days prior to first dose of study drug\n* Hemoglobin \\>= 9.0 g\u002FdL (obtained =\\\u003C 15 days prior to registration) (without transfusion or erythropoietin \\[EPO\\] dependency =\\\u003C 7 days prior to assessment)\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* Platelet count \\>= 100,000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* Creatinine =\\\u003C 1.5 x upper limits of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be \\>= 45 ml\u002Fmin (obtained =\\\u003C 15 days prior to registration)\n* Total bilirubin =\\\u003C1.5 x ULN OR direct bilirubin =\\\u003C ULN for patients with total bilirubin levels \\>1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* Aspartate transaminase (AST) AND alanine transaminase (ALT) =\\\u003C 2.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN OR if patient is receiving anticoagulant therapy then INR or aPTT is within target range of therapy (obtained =\\\u003C 15 days prior to registration)\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only (POCBP) Note: If testing done for eligibility is \\> 72 hours prior to first dose, then pregnancy testing must be repeated, and result must be negative for patient to receive treatment.\n* POCBP or able to father a child must be willing to use adequate contraception starting with first dose through 180 days after last dose\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).\n* Willing to provide tissue and blood samples for correlative research purposes\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent for which genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait).\n* Prior treatment\n\n  * Received bevacizumab (AVASTIN) =\\\u003C 4 months prior to registration\n\n    * Note: Bevacizumab is allowed for symptom control during the adjuvant phase of the study\n  * Received a live vaccine =\\\u003C 30 days prior to registration.\n  * Requirement for dexamethasone dose of \\> 2mg\u002Fday =\\\u003C 2 days prior to registration\n* Failure to recover from any adverse events related to any of the following therapies received prior to registration:\n\n  * Major surgery =\\\u003C 28 days prior to registration\n  * Radiation therapy =\\\u003C 14 days prior to registration\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Known history of human immunodeficiency virus (HIV) infection\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations (e.g., drug addiction) that would limit compliance with study requirements\n* Receiving any other investigational agent\n* Other active malignancy requiring systemic treatment =\\\u003C 1 year prior to registration\n* History of myocardial infarction =\\\u003C 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) =\\\u003C 2 years prior to registration NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Concurrent known active Hepatitis B (i.e., known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] reactive) AND known active Hepatitis C (i.e., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] detected by polymerase chain reaction \\[PCR\\])\n\n  * Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority\n  * NOTE: Patients with known Hepatitis B OR Hepatitis C may be enrolled if they meet the following criteria:\n\n    * Hepatitis B: Patients who are HBsAG positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on anti-viral therapy throughout the treatment phase of the trial and should follow local guidelines for HBV anti-viral therapy after completing study treatment\n    * Hepatitis C: Patients with history of Hepatitis C infection are eligible if HCV viral load is undetectable at screening. Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration\n* Known history of active TB (Bacillus Tuberculosis)\n* History of (non-infectious) pneumonitis or interstitial lung disease that required steroids, or current pneumonitis or interstitial lung disease\n* Hypersensitivity to pembrolizumab or any of its excipients\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent within \\\u003C 12 months prior to registration\n\n  * NOTE: If such therapy was given ≥ 12 months prior to registration, patient is eligible\n* History of allogenic tissue\u002Fsolid organ transplant",{"count":152,"type":20},54,[127],"This phase II trial tests the safety and side effects of efineptakin alfa and pembrolizumab in treating patients with glioblastoma that has come back (recurrent). Efineptakin alfa is an immunotherapy drug that works by helping the immune system fight tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving efineptakin alfa and pembrolizumab may kill more tumor cells in patients with recurrent glioblastoma.",[156,58,26],"High Grade Astrocytic Tumor","2026-01-09",{"date":159,"type":33},"2026-01-12",{"date":161,"type":33},"2023-01-24",{"date":163,"type":20},"2028-10-15",{"name":143,"class":40}]