[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651268":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":51,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":24,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":76,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"FutureGen Biopharmaceutical (Beijing) Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation Cohort","EXPERIMENTAL","Dose Escalation Cohort Eight dose levels of FG-M131 will be tested according to an accelerated titration method followed by a adaptive BOIN design.",[13],"Drug: FG-M131",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Expansion Cohort","Once the effective dose has been determined, 2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.",[13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","FG-M131","Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)",[9],null,{"type":20,"name":21,"description":26,"armGroupLabels":27,"otherNames":24},"1\\~2 dose levels of FG-M131 will be tested according to the result from dose escalation stage",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Zhaoyu Jin","CONTACT","+8610-60709130","pr@futuregenbiopharm.com",[35],{"facility":36,"status":24,"city":37,"state":24,"zip":24,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Beijing Cancer Hospital","Beijing","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},[47],{"name":48,"role":31,"phone":49,"phoneExt":24,"email":50},"Yuqin Song","+8610-88196118","SongYQ_VIP@163.com",{"type":52,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","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":64,"type":65},110,"ESTIMATED","INTERVENTIONAL",[68,69],"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.",[72,73,74],"PTCL","TRBC1 ADC","CTCL",[72,73,74],"NOT_YET_RECRUITING","2026-08-06",{"date":79,"type":80},"2026-08-11","ACTUAL",{"date":82,"type":65},"2026-08-30",{"date":84,"type":65},"2031-04",{"name":5,"class":6},1]