[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ctcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ctcl":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100651268","phase-1-a-phase-iii-study-of-fg-m131-in-trbc1-relapsedrefractory-peripheral-t-cell-lymphoma-100651268",false,"NCT07758491","A Phase I\u002FII Study of FG-M131 in TRBC1+ Relapsed\u002FRefractory Peripheral T-Cell Lymphoma","An Open-label, Multicenter Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FG-M131 in Patients With TRBC1-positive Relapsed\u002FRefractory Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n* Voluntarily sign the informed consent form, understand the study, are willing to comply with and have the ability to complete all trial procedures;\n* Age 18-75 years (inclusive), any gender;\n* Histologically and\u002For cytologically confirmed peripheral T-cell lymphoma or cutaneous T-cell lymphoma;\n* Relapsed or refractory lymphoma after at least one prior line of therapy；\n* Able to provide tumor tissue specimens;\n* ECOG performance status of 0 or 1;\n* Expected survival ≥3 months;\n* Have at least one measurable tumor lesion;\n* Adequate cardiac, bone marrow, liver, renal function;\n\nExclusion Criteria:\n\n* Have received a live vaccine within 3 months prior to the first dose;\n* Have received radiotherapy within 4 weeks prior to the first dose;\n* Have received other anti-tumor drug therapy within 3 weeks or within 5 half-lives of the anti-tumor drug prior to the first dose;\n* Have undergone major surgery within 4 weeks prior to the first dose;\n* Have previously received any therapy targeting the TRBC1 antigen or any antibody-drug conjugate with MMAE payload;\n* Have received autologous stem cell transplantation within 3 months prior to the first dose;\n* Have previously received allogeneic stem cell transplantation;\n* Have a history of other malignancies within 5 years prior to the first dose;\n* Have received high-dose systemic vitamin A therapy (daily dose \\>15,000 IU \\[i.e., 5,000 mcg\\]) within 3 weeks prior to the first dose of study drug;\n* Have any condition requiring systemic treatment with corticosteroids (\\>20 mg\u002Fday prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose;\n* Have received oral retinoid drugs for any indication within 3 weeks prior to the first dose;\n* Have adverse reactions from prior treatments that have not recovered to CTCAE v5.0 Grade ≤1 (excluding alopecia and anemia) prior to the first dose;\n* Presence or history of central nervous system lymphoma, leptomeningeal disease, or spinal cord compression;\n* Have a history of severe allergic reactions or are allergic to the investigational drug;\n* Have experienced a clinically significant cardiac disease within 6 months before the first dose;\n* Have uncontrolled systemic diseases assessed by the investigator, including diabetes, hypertension, pulmonary fibrosis, interstitial lung disease, etc.;\n* Known history of Hepatitis C or chronic active Hepatitis B;\n* Clinically uncontrolled diseases such as diabetes mellitus, thyroid disease, or other severe systemic diseases requiring systemic treatment;\n* Active or progressive infection requiring systemic therapy within 2 weeks prior to the first dose;\n* Known or suspected active autoimmune disease requiring systemic therapy within 2 years prior to the first dose;\n* Are pregnant or breastfeeding;","ALL","18 Years","75 Years",{"count":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","FG-M131 for injection is an antibody-drug conjugate (ADC) targeting the T-cell receptor beta chain constant region 1 (TRBC1). TRBC1 is a subunit of the αβ T-cell receptor (TCR) complex. Targeting TRBC1 can eliminate TRBC1-positive malignant T cells while sparing TRBC2-positive normal T cells, providing a novel strategy for the treatment of T-cell malignancies.\n\nThis study is a multicenter, open-label Phase I\u002FII clinical trial in patients with TRBC1-positive relapsed\u002Frefractory peripheral T-cell lymphoma, designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary antitumor activity of FG-M131 for injection in this patient population. The study consists of a Phase I dose-escalation stage and a Phase IIa cohort-expansion stage.",[28,29,30],"PTCL","TRBC1 ADC","CTCL",[28,29,30],"NOT_YET_RECRUITING","2026-08-06",{"date":35,"type":36},"2026-08-11","ACTUAL",{"date":38,"type":21},"2026-08-30",{"date":40,"type":21},"2031-04",{"name":42,"class":43},"FutureGen Biopharmaceutical (Beijing) Co., Ltd","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100581772","phase-2-a-phase-2-study-of-ptx-100-in-patients-with-relapsedrefractory-ctcl-100581772","NCT06854653","A Phase 2 Study of PTX 100 in Patients With Relapsed\u002FRefractory CTCL","An Open-Label, Phase 2 Study of PTX-100 Monotherapy in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma.","Inclusion Criteria:\n\n1. Adult patient ≥18 years of age at the time of signing the informed consent.\n2. Patient is capable of giving adequate signed informed consent\n3. Have a confirmed diagnosis of CTCL with histological confirmation\n4. Patients must have greater than or equal to Stage Ib disease.\n5. Has received and failed (or intolerant of) at least 2 prior lines of prior systemic therapy for their disease.\n6. Has measurable disease defined by at least one of the following, within 28 days prior to start of study treatment: by evaluable by mSWAT or quantifiable by flow cytometry or morphology in blood or measurable by Lugano Criteria.\n7. On a stable dose of systemic corticosteroid (\\\u003C 10 mg prednisone or equivalent) are permitted. Participants on a stable dose of topical corticosteroids are permitted.\n8. Washout period- must be 2 weeks (4 weeks for monoclonal antibodies) or 5 -half-lives (whichever is longer) since any prior anti-cancer therapy.\n9. Must be human T-cell lymphotropic virus type 1 (HTLV1) negative.\n10. Has an ECOG PS of 0 to 2.\n11. Life expectancy of 3 months or greater\n12. Has adequate bone marrow function.\n13. Has adequate hepatic function.\n14. Has adequate Renal function.\n15. Has adequate coagulation function.\n16. Patients with Human Immunodeficiency virus (HIV) must be on established and stable effective anti-retroviral therapy for at least 4 weeks and have an HIV viral load of less than 400 copies\u002FmL.\n17. Male patients are eligible to participate if they agree to use a highly effective contraception during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.\n18. Female patients are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n    -Not a woman of childbearing potential (WOCBP).\n    * OR\n    * A WOCBP who agrees to use a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year) or be abstinent from heterosexual intercourse as their preferred method and usual lifestyle, beginning the time of informed consent, during the treatment period and for at least 3 months after the last dose of study treatment.\n19. A WOCBP must have a negative serum pregnancy within 72 hours of the first dose of study treatment.\n20. Must be willing and able to adhere to the study as judged by the Investigator.\n\nExclusion Criteria:\n\n1. Patients with known central nervous system involvement.\n2. Patients who require the use of strong inhibitors or inducers of CYP enzymes or transporters (e.g., CYP3A4, 2D6, 2C19) or (P-gp, BCRP, OATP1B1, OATP1B3, OAT1. OAT3, OCT2, MATE1 and MATE2-K). Patients who are receiving these medications at Screening can be enrolled into the trial if they discontinue them for at least 14 days or 5 half-lives, whichever is longer, before they commence PTX-100. An alternative pharmacological treatment should be instituted by the treating clinician based on clinical judgement.\n3. Significant cardiovascular disease. A history of, or concurrent interstitial lung disease or severely impaired lung function.\n\n5\\. Active viral, bacterial, fungal infection or other serious infection requiring ongoing systemic treatment. Routine antimicrobial prophylaxis is permitted.\n\n6\\. Medical history of another malignant tumor within the past 5 years. Exceptions are patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ who have undergone curative therapy with no evidence of disease.\n\n7\\. On an immunomodulatory drug for concomitant or intercurrent conditions or who have received any of these agents within 4 weeks of baseline.\n\n8\\. Patients with active viral (any etiology) hepatitis are excluded. However, patients with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV deoxyribose nucleic acid titer \\\u003C 1000 cps\u002FmL or 200 IU\u002FmL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Medical Monitor. Patients with a history of hepatitis C virus infection who have completed curative antiviral treatment and have a viral load below the limit of quantification may be eligible and should be discussed with the Medical Monitor.\n\n9\\. A history or current evidence of any condition, laboratory abnormality or other circumstance that might confound the results of the study or interfere with patient participation for the full duration of the study.\n\n10\\. Prior allogeneic or autologous hematopoietic transplantation 11. Has a known psychiatric disorder that would interfere with compliance with the requirements of the study.\n\n12\\. Is a consumer of illicit or recreational drugs or has a recent history (within the last year) of drug or alcohol abuse or dependence that in the judgment of the Investigator, would interfere with compliance with the requirements of the study.",{"count":53,"type":21},115,[25],"This is an open-label, phase 2 randomized study to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmadynamics (PD), of PTX-100 monotherapy at 500 or 1000 mg\u002Fm2 in patients with relapsed\u002Frefractory Cutaneous T-Cell Lymphoma (CTCL).\n\nPTX-100 will be administered by IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles, then 21 day cycle thereafter. Subjects will be treated or followed up, if subjects discontinue treatment, for up to 18 months.",[30],[58,30,59,60,61,62,63,64],"Relapsed or refractory Cutaneous T Cell Lymphoma","PTX-100","Mycosis Fungoides","Sezary Syndrome","T Cell Lymphoma","Non-Hodgkin Lymphoma","Cutaneous Lymphoma","RECRUITING","2026-04-28",{"date":68,"type":36},"2026-04-29",{"date":70,"type":36},"2025-03-28",{"date":72,"type":21},"2028-06",{"name":74,"class":43},"Prescient Therapeutics, Ltd.",15,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":44},"100369230","stratactx-as-a-steroid-sparing-device-100369230","NCT04087629","StrataCTX® as a Steroid Sparing Device","Post-marketing Surveillance of StrataCTX® Flexible Wound Dressing for Use as a Steroid Sparing Agent","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ability to sign informed consent document\n* Patient with a diagnosis of CTCL who have contact dermatitis to topical mechlorethamine gel\n* Patients with a diagnosis of CTCL who have intractable pruritis\n* Patients with a diagnosis of CTCL who rely heavily on topical steroids for symptomatic relief\n* Patients on chemo\u002Fimmunotherapy with drug induced rash\n\nExclusion Criteria:\n\n* Patients currently undergoing radiotherapy\n* Patients currently receiving oral steroids\n* Patients who are unable to apply topical medications",{"count":84,"type":21},70,[86],"NA","The purpose is to determine if StrataCTX® can be used as a steroid sparing agent for the treatment of cutaneous reactions related to, cutaneous T Cell lymphoma (CTCL) and chemotherapy\u002Fimmunotherapy treatments than the current standard treatment - topical steroids - in people who are receiving treatment for CTCL, or chemotherapy\u002Fimmunotherapy for solid\u002Fhematologic malignancies. Subjects will have CTCL and are being treated with topical steroids, or being treated with chemotherapy\u002Fimmunotherapy for another condition and have had cutaneous reactions that have warranted initiation of topical steroids.",[30],[30,90,91,92,93],"topical steroids","StrataCTX®","cutaneous","steroid sparing","2025-09-29",{"date":96,"type":36},"2025-10-02",{"date":98,"type":36},"2021-07-07",{"date":100,"type":21},"2026-08",{"name":102,"class":103},"Columbia University","OTHER"]