[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-or-progressive-glioblastoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-or-progressive-glioblastoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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},"100652903","phase-1-a-phase-1-open-label-dose-escalation-study-to-evaluate-safety-tolerability-and-clinical-activity-of-cbx-663-in-participants-with-relapsed-or-refractory-myeloid-malignancies-advanced-solid-tumors-or-recurrent-or-progressive-glioblastoma-100652903",false,"NCT07779798","A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-663 in Participants With Relapsed or Refractory Myeloid Malignancies, Advanced Solid Tumors, or Recurrent or Progressive Glioblastoma.","TelOscope","Inclusion Criteria:\n\nCohort A (R\u002FR AML, MDS or CMML) Specific Inclusion Criteria:\n\n1. R\u002FR AML, as defined by standardized criteria (e.g., European Leukemia Net criteria (Dohner, 2022) (Arber, 2022); after standard of care therapy. Participants with persistent leukemia after initial therapy or with recurrence of leukemia at any time after achieving a response during or after the course of treatment (including HSCT) are eligible. Participants must have bone marrow blasts ≥5%.\n2. R\u002FR MDS as per WHO 2022. Participants must have peripheral or bone marrow blasts \\\u003C20%, and must have exhausted locally available treatments, including treatments for actionable mutations.\n\n   a. For High-Risk MDS participants, participants must be resistant to or refractory to at least 4 cycles of hypomethylating agents or have progressed or are intolerant to such agents.\n3. R\u002FR dysplastic or proliferative CMML participants, participants must be resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).\n4. White blood cells must be below 25,000\u002FµL at time of enrollment. Participants may receive cytoreduction prior to enrollment.\n5. Any prior treatment-related toxicities resolved to Grade ≤1 prior to enrollment, with the exception of Grade ≤2 alopecia.\n\n   Cohort B (Solid Tumor) Specific Inclusion Criteria:\n6. Histologically or cytologically diagnosed, locally advanced (unresectable) or metastatic solid cancers that have progressed after all available standard therapy for the specific tumor type, or for which no standard therapy exists. Participants for whom standard therapies are intolerable or considered inappropriate by the Investigator are eligible.\n7. Measurable disease (as defined by RECIST version 1.1).\n\n   Prior Therapy\n8. Any prior treatment-related toxicities resolved to Grade ≤1 prior to enrollment, with the exception of Grade ≤2 alopecia.\n9. Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily) or cytoreductive therapy. Cytoreductive therapy must have approval of the Study Responsible Physician.\n10. Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors.\n11. Anti-Cancer Therapy: Chemotherapy or small molecule targeted therapy, either investigational or commercially approved and available, within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of study drug administration.\n12. Radiation Therapy: At least 60 days from prior total body irradiation, craniospinal radiation and\u002For ≥50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port).\n\n    Cohort C (Recurrent\u002FProgressive GBM) Specific Inclusion Criteria:\n13. Histologically confirmed or molecularly defined diagnosis of glioblastoma (IDH-wildtype) according to WHO 2021.\n14. Historical documented evidence of a TERT promoter mutation.\n15. Radiographic evidence of recurrent or progressive disease following prior first-line radiotherapy, defined as progression per RANO 2.0 criteria, as determined by investigator assessment. Prior use of tumor-treating fields is allowed but not required (Wen, 2023).\n16. Measurable (at least 1 cm x 1 cm) enhancing tumor.\n17. Any prior treatment-related toxicities resolved to ≤Grade 1 prior to enrollment, with the exception of ≤Grade 2 alopecia and ≤Grade 2 fatigue.\n\n    Inclusion Criteria for All Participants:\n18. Aged ≥18 years.\n19. Backfill Cohorts: Participants for whom no curative treatment options, including transplantation, are available.\n20. Historical documented evidence of HLA-A\\*02:01 allele positivity.\n21. ECOG PS score 0-1. Adequate Organ Function Requirements within 10 Days of Treatment Initiation\n22. Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m2 based on local institutional practice (e.g., Cockcroft-Gault formula).\n23. Adequate liver function defined as:\n\n    * Total bilirubin \\\u003C1.5 × the upper limit of normal (ULN) for age or normal conjugated bilirubin, or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in participants with well documented Gilbert's syndrome or hemolysis or who require regular blood transfusions.\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 × ULN (unless attributed to leukemic or tumor involvement with discussion with the Study Responsible Physician).\n24. If a female of childbearing potential, willing to use a highly effective method of contraception or double barrier method from the time of enrollment through 120 days following the last study drug dose.\n25. If male of childbearing potential, agrees to use barrier contraception from the time of enrollment through 120 days following the last study drug dose.\n26. Participant or participant's health care proxy is able and willing to provide written informed consent and able to follow study instructions.\n\nExclusion Criteria:\n\nCohort C (Recurrent\u002FProgressive GBM) Specific Exclusion Criteria:\n\n1. Known or suspected leptomeningeal disease are excluded, defined as radiographic evidence of leptomeningeal involvement on MRI of the brain and\u002For spine, or positive cerebrospinal fluid (CSF) cytology, at screening or prior to first dose.\n2. Tumors involving the brainstem or spinal cord are excluded, including primary tumors arising from, or metastatic lesions involving, the brainstem (midbrain, pons, or medulla) or spinal cord.\n3. Received prior bevacizumab or any other anti-VEGF or anti-VEGFR therapy.\n4. Absolute lymphocyte count \\\u003C800\u002FuL.\n5. Clinically significant mass effect or midline shift.\n\n   Exclusion Criteria for All Participants:\n6. Previous treatment with any pHLA-targeting T-cell engager.\n7. Isolated extramedullary relapse.\n8. Active central nervous system (CNS) disease. Participants with prior CNS history can be enrolled if the participant has a negative lumbar puncture following completion of intrathecal chemotherapy.\n\n   • Note: this does not apply to Cohort C GBM participants\n9. Known HIV infection.\n10. Active hepatitis B infection (participants with documented clearance following treatment are allowed).\n11. Active hepatitis C infection (participants with documented clearance following treatment are allowed).\n12. Any acute or chronic infection requiring systemic treatment\n13. Pregnant or nursing women: Negative serum pregnancy tests are required during Screening and a negative serum or urine pregnancy test is required within 72 hours prior to receiving the first study drug administration, in females of childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n14. Cardiac Disease:\n\n    * Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Classification Class \\>II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.\n    * QTc using Fridericia's correction (QTcF) \\>480 msec\n15. Graft-Versus-Host Disease (GVHD): Active GVHD.\n16. Concurrent malignancy in the previous 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy. Concurrent malignancy must be in CR or no evidence of disease (NED) during this timeframe.\n17. Current or historical diagnosis of a gastrointestinal autoimmune or inflammatory condition, including but not limited to ulcerative colitis (UC), Crohn's disease (CD), indeterminate colitis, or microscopic colitis (collagenous or lymphocytic colitis), or a history of GI toxicity from previous therapy that, in the opinion of the investigator, should preclude study participation.\n18. Significant impairment of lung function requiring chronic use of ambulatory supplemental oxygen.\n19. Screening laboratory values or investigations that do not meet the requirements for adequate organ function.\n20. History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate.\n21. Any commercially available or investigational anti-leukemic or anti-cancer therapy other than CBX 663, with the following exceptions:\n\n    • Intrathecal chemotherapy for CNS prophylaxis is permitted after C1 is complete, at the treating physician's discretion.\n22. Participants who experienced severe, life-threatening or recurrent (≥ Grade 2) immune-mediated adverse events or infusion-related reactions including those that led to permanent discontinuation while on previous treatment with immuno-oncology agents.\n23. Any concurrent systemic treatment to prevent GVHD. Topical treatments for GVHD are permitted. Participants who stopped calcineurin inhibitor (CNI) prophylaxis should be off CNI for at least 4 weeks.\n24. Known allergy or sensitivity to study drug, including excipients.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1, open-label, dose-escalation study of CBX-663 in participants with R\u002FR AML, MDS or CMML (Cohort A), advanced solid tumors (Cohort B), or recurrent or progressive GBM (Cohort C) (collectively called 'indication cohorts'). Participants aged ≥18 years are planned to be enrolled. CBX-663 will initially be investigated on a fixed dosing schedule. CBX-663 will be administered intravenously (IV) on Cycle 1 Day 1 (C1D1) and then once weekly (QW) in 21-day cycles. Participants will continue treatment with CBX-663 until unacceptable toxicity, progressive disease, withdrawal of consent, or lack of clinical benefit.",[26,27,28],"Advanced Solid Tumors","Recurrent or Progressive Glioblastoma","Relapse or Refractory Myeloid Malignancies","NOT_YET_RECRUITING","2026-08-18",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":20},"2026-08",{"date":37,"type":20},"2028-06",{"name":39,"class":40},"Crossbow Therapeutics, Inc.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100569212","early-phase-1-wl276-car-t-cell-therapy-for-cd276-positive-recurrent-or-progressive-glioblastoma-patients-100569212","NCT06691308","WL276 CAR-T Cell Therapy for CD276 Positive Recurrent or Progressive Glioblastoma Patients","Clinical Study Evaluating the Safety and Efficacy of WL276 CAR-T Cell Therapy in CD276 Positive Recurrent or Progressive Glioblastoma Patients","Inclusion Criteria:\n\n1. Diagnosed with glioblastoma through histopathological examination;\n2. Patients with unresectable recurrent or progressive glioblastoma who have failed or are intolerant to standard treatment; 8.1The standardized systematic treatment received by patients must comply with the 2022 edition of the \"Guidelines for the Treatment of Gliomas\"; 8.2Requirements for treating intolerance: Refers to patients who are unable to continue the current effective systemic standardized treatment due to toxic side effects such as vomiting, diarrhea, abdominal pain, bone marrow suppression, etc. of grade ≥ 3. Refusal due to economic or personal reasons is not accepted;\n3. Age ≥ 18 years old, including boundary values;\n4. Expected survival period greater than 2 months;\n5. There is at least one measurable intracranial lesion that meets the criteria of Neuro Tumor Response Evaluation (RANO);\n6. Patients must provide tumor samples within 2 years that meet the requirements (paraffin blocks or unstained sections with a quantity that meets the testing requirements specified in this study) and have positive CD276 expression detected by immunohistochemistry;\n7. Karnofsky (KPS) functional status score ≥ 60 points;\n8. Blood routine:\n\n   8.1Hemoglobin (Hb) ≥ 90g\u002FL; 8.2Absolute neutrophil count (ANC) ≥ 1.5 × 10 \\^ 9\u002FL; 8.3Platelet count (PLT) ≥ 70 × 10 \\^ 9\u002FL; 8.4Absolute value of lymphocytes ≥ 0.5 × 10 \\^ 9\u002FL;\n9. The liver, kidney, heart, and lung functions meet the following requirements:\n\n   9.1Creatinine clearance rate ≥ 60ml\u002Fmin; 9.2Alanine transaminase (ALT) and aspartate transaminase 9.3Aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBL) ≤ 1.5 × ULN (for the elevation of ALT and AST that can be explained by liver invasion, AST and ALT high limit can be upregulated up to 5-fold, and TBL high limit can be upregulated up to 3-fold); 9.4Serum albumin ≥ 3.0g\u002FdL; 9.5Left ventricular ejection fraction ≥ 50%, no pericardial effusion \\[ECHO (Echocardiography, ECHO) examination\\], no clinically significant ECG (Electrocardiogram, ECG) results; 9.6Blood oxygen saturation is greater than 95% under non oxygen inhalation conditions.\n10. Women of childbearing age who have a negative blood pregnancy test before the start of the trial and agree to take effective contraceptive measures during the trial period until the last follow-up; Male participants with reproductive partners agree to take effective contraceptive measures during the trial period until the last follow-up;\n11. Those who voluntarily participate in this experiment and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Those who require the use of immunosuppressants; Or individuals with autoimmune diseases;\n2. Patients who have received or are waiting for organ transplantation in the past;\n3. The toxicity caused by previous treatment has not stabilized or recovered to ≤ level 1 (except for cases judged by the researcher to be clinically insignificant);\n4. There is a large amount of uncontrollable serosal fluid accumulation (such as pleural effusion, abdominal effusion, pericardial effusion) after treatment;\n5. Use any of the following drugs or treatment methods within the specified time before cell collection:\n\n   5.1Used therapeutic doses of corticosteroids within one week prior to cell collection. But the use of topical and inhaled steroids is allowed; 5.2Received chemotherapy drugs within one week prior to cell collection. If the oral chemotherapy drug has passed at least 3 half lives before cell collection, it is allowed to be included in the group; 5.3Individuals who use drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to cell collection;\n6. CNS diseases that have clinical significance in the past or screening, and have been assessed by researchers as having safety risks;\n7. Individuals who have previously used any gene therapy products;\n8. Active hepatitis B or hepatitis C virus is defined as: subjects who are positive for hepatitis B B virus surface antigen (HBsAg) or hepatitis B B core antibody (HBcAb) and whose peripheral blood HBV DNA titer is higher than the upper limit of detection; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA (HCV RNA); People infected with AIDS virus and syphilis;\n9. Active EBV and cytomegalovirus are defined as patients with positive or negative IgM antibodies in EBV serum but EBV-DNA levels higher than normal; Patients with IgM antibody positive or IgM antibody negative but CMV-DNA higher than normal in the serum of cytomegalovirus (CMV);\n10. Used the research drug within 4 weeks prior to cell collection. But if the experimental treatment is ineffective or if the disease progresses, and at least 5 half lives have passed before cell collection, it is allowed to be included in the group;\n11. Received radiation therapy within 4 weeks prior to cell collection;\n12. Patients who have undergone major surgical procedures or significant trauma within 4 weeks prior to cell collection, or who are expected to undergo major surgery during the study period;\n13. If immunotherapy such as anti-PD1 and PD-L1 has been used before cell infusion, at least 5 half lives must be passed between the last dose and CAR-T cell infusion;\n14. Abnormal cardiac function includes: long QTc syndrome or QTc interval\\>480 ms; Complete left bundle branch block, grade II\u002FIII atrioventricular block; Severe and uncontrolled arrhythmias requiring medication treatment; History of chronic congestive heart failure and NYHA ≥ 3 (refer to Appendix 4) with a heart ejection fraction below 50% within the 6 months prior to screening; Heart valve disease with CTCAE ≥ 3 grade; Within the first 6 months of screening, there has been a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina, severe pericardial disease, or other clinically significant heart diseases;\n15. Patients who require anticoagulant therapy;\n16. Patients requiring long-term antiplatelet therapy;\n17. Start screening for symptomatic history of venous thrombosis or pulmonary embolism within the previous 6 months;\n18. History of malignant tumors other than non melanoma skin cancer or carcinoma in situ (such as cervical, bladder, breast) (unless in a disease-free state for at least 3 years);\n19. Infections (fungal, bacterial, viral, or other) that require intravenous injection of antibiotics for control or are uncontrollable, such as simple urinary tract infections and bacterial pharyngitis, can be included if the researcher evaluates that they can be controlled through treatment;\n20. Unable to perform MRI examination (such as installing pacemakers, metal dentures, etc.)\n21. The researcher shall determine whether the patient has any factors that affect compliance with the protocol, or is unwilling or unable to comply with the procedures required in the research protocol.",{"count":50,"type":20},6,[52],"EARLY_PHASE1","Clinical study evaluating the safety and efficacy of WL276 CAR-T cell therapy in CD276 positive recurrent or progressive glioblastoma patients",[27],[56,57],"WL276 CAR-T cells","CD276 positive","2024-11-14",{"date":60,"type":33},"2024-11-18",{"date":62,"type":20},"2024-11-12",{"date":64,"type":20},"2027-05-31",{"name":66,"class":40},"Beijing Immunochina Medical Science & Technology Co., Ltd."]