[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"trbc1-adc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:trbc1-adc":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":5},"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"]