[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633197":3},{"organization":4,"armGroups":7,"interventions":49,"overallOfficials":55,"centralContacts":84,"locations":90,"responsibleParty":110,"collaborators":55,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":55,"studyType":126,"phases":127,"briefSummary":130,"conditions":131,"keywords":139,"overallStatus":93,"whyStopped":55,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,14,19,24,29,34,39,44],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A1 CD19\u002FCD22","EXPERIMENTAL","B-ALL, DLBCL, FL, MCL, PMBCL, CLL\u002FSLL, or Richter transformation with confirmed CD19-positive \u002F CD22-positive disease.",[13],"Biological: Autologous CD19\u002FCD22 dual-target CAR-T module",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm A2 CD19\u002FCD20","B-NHL or CLL\u002FSLL with CD19-positive \u002F CD20-positive disease, especially mature B-cell phenotype or relapse after prior CD19-directed therapy.",[18],"Biological: Autologous CD19\u002FCD20 dual-target CAR-T module",{"label":20,"type":10,"description":21,"interventionNames":22},"Arm B1 BCMA\u002FCD19","Multiple myeloma or plasma cell leukemia with BCMA-positive disease plus evidence of a CD19-positive minor clone, precursor phenotype, or marked clonal heterogeneity.",[23],"Biological: Autologous BCMA\u002FCD19 dual-target CAR-T module",{"label":25,"type":10,"description":26,"interventionNames":27},"Arm B2 BCMA\u002FCD38","Multiple myeloma or plasma cell leukemia with BCMA-positive \u002F CD38-positive disease and a plasma-cell-dominant phenotype.",[28],"Biological: Autologous BCMA\u002FCD38 dual-target CAR-T module",{"label":30,"type":10,"description":31,"interventionNames":32},"Arm B3 BCMA\u002F GPRC5D","Multiple myeloma or plasma cell leukemia with BCMA-positive \u002F GPRC5D-positive disease, especially after prior BCMA exposure or with high escape risk.",[33],"Biological: Autologous BCMA\u002FGPRC5D dual-target CAR-T",{"label":35,"type":10,"description":36,"interventionNames":37},"Arm C1 CD33\u002FCD123","AML, high-risk MDS, or BPDCN with CD33-positive \u002F CD123-positive disease",[38],"Biological: Autologous CD33\u002FCD123 dual-target CAR-T module",{"label":40,"type":10,"description":41,"interventionNames":42},"Arm C2 CD33\u002FCLL1","AML with CD33-positive \u002F CLL1(CLEC12A)-positive disease, particularly stem-cell-rich or measurable residual disease patterns.",[43],"Biological: Autologous CD33\u002FCLL1 dual-target CAR-T module",{"label":45,"type":10,"description":46,"interventionNames":47},"Arm D1 CD5\u002FCD7","T-ALL, T-LBL, or peripheral T-cell lymphoma with dual CD5-positive \u002F CD7-positive expression and a feasible fratricide-mitigation plan.",[48],"Biological: Autologous CD5\u002FCD7 dual-target CAR-T module",[50,56,60,64,68,72,76,80],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"BIOLOGICAL","Autologous CD19\u002FCD22 dual-target CAR-T module","Biological: Autologous CD19\u002FCD22 dual-target CAR-T module after lymphodepletion with fludarabine\u002Fcyclophosphamide.",[9],null,{"type":51,"name":57,"description":58,"armGroupLabels":59,"otherNames":55},"Autologous CD19\u002FCD20 dual-target CAR-T module","Biological: Autologous CD19\u002FCD20 dual-target CAR-T module after lymphodepletion with fludarabine\u002Fcyclophosphamide.",[15],{"type":51,"name":61,"description":62,"armGroupLabels":63,"otherNames":55},"Autologous BCMA\u002FCD19 dual-target CAR-T module","Biological: Autologous BCMA\u002FCD19 dual-target CAR-T module after lymphodepletion with fludarabine\u002Fcyclophosphamide.",[20],{"type":51,"name":65,"description":66,"armGroupLabels":67,"otherNames":55},"Autologous BCMA\u002FCD38 dual-target CAR-T module","Biological: Autologous BCMA\u002FCD38 dual-target CAR-T module after lymphodepletion with fludarabine\u002Fcyclophosphamide.",[25],{"type":51,"name":69,"description":70,"armGroupLabels":71,"otherNames":55},"Autologous BCMA\u002FGPRC5D dual-target CAR-T","Biological: Autologous BCMA\u002FGPRC5D dual-target CAR-T module after lymphodepletion with fludarabine\u002Fcyclophosphamide",[30],{"type":51,"name":73,"description":74,"armGroupLabels":75,"otherNames":55},"Autologous CD33\u002FCD123 dual-target CAR-T module","Biological: Autologous CD33\u002FCD123 dual-target CAR-T module (simultaneous or planned sequential paired infusion, module-specific) after lymphodepletion.",[35],{"type":51,"name":77,"description":78,"armGroupLabels":79,"otherNames":55},"Autologous CD33\u002FCLL1 dual-target CAR-T module","Biological: Autologous CD33\u002FCLL1 dual-target CAR-T module after lymphodepletion with fludarabine\u002Fcyclophosphamide.",[40],{"type":51,"name":81,"description":82,"armGroupLabels":83,"otherNames":55},"Autologous CD5\u002FCD7 dual-target CAR-T module","Biological: Autologous CD5\u002FCD7 dual-target CAR-T module (including sequential paired infusion if needed for manufacturing\u002Fsafety) after lymphodepletion.",[45],[85],{"name":86,"role":87,"phone":88,"phoneExt":55,"email":89},"shan S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[91],{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":100,"coordinates":101},"Point",[102,103],114.0683,22.54554,{"lat":103,"lon":102},[106],{"name":107,"role":87,"phone":108,"phoneExt":55,"email":109},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":111,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100633197","phase-1-adaptive-dual-target-car-t-cells-for-relapsed-or-refractory-hematologic-malignancies-100633197",false,"NCT07523555","Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies","A Phase 1\u002F2, Open-Label, Nonrandomized, Multi-arm Umbrella Study of Biomarker-Selected Dual-Target CAR-T Cell Modules in Adults With Relapsed or Refractory Hematologic Malignancies","ADAPT-HEM","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Pathologically or cytologically confirmed eligible disease: B-ALL; B-cell NHL\u002FCLL\u002FSLL; multiple myeloma\u002Fplasma cell leukemia; AML\u002Fhigh-risk MDS\u002FBPDCN; or T-ALL\u002FT-LBL\u002Fperipheral T-cell lymphoma.\n* Relapsed or refractory disease after at least 2 prior lines of therapy, or no curative\u002Fapproved standard option judged appropriate by the investigator.\n* Central laboratory confirmation that at least one active dual-target module is suitable based on malignant-cell antigen co-expression and safety review.\n* Measurable or otherwise evaluable disease by disease-specific response criteria.\n* ECOG performance status 0 to 2.\n* Adequate organ function: LVEF \\>= 45%; creatinine clearance \\>= 40 mL\u002Fmin; AST\u002FALT \\\u003C= 3 x ULN; total bilirubin \\\u003C= 1.5 x ULN unless due to Gilbert syndrome; oxygen saturation \\>= 92% on room air.\n* Adequate hematologic reserve unless cytopenia is clearly disease-related.\n* Ability to undergo leukapheresis and willingness to comply with study procedures and follow-up.\n* If prior allogeneic HSCT: at least 100 days from transplant, no uncontrolled GVHD, and no systemic immunosuppression above physiologic steroid replacement.\n* Negative pregnancy test for participants of childbearing potential and agreement to use effective contraception during protocol-defined risk periods.\n* Written informed consent obtained before any study-specific procedure.\n\nExclusion Criteria:\n\n* \\- Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection, or clinical sepsis.\n* Active symptomatic CNS involvement requiring escalating therapy; previously treated\u002Fstable CNS disease may be allowed if defined prospectively in the final protocol.\n* Prior gene-modified cellular therapy within 12 weeks before leukapheresis, or unresolved \\>= Grade 3 toxicity from prior anticancer therapy\n* Need for urgent cytoreduction such that manufacturing delay would create unacceptable clinical risk.\n* Active autoimmune disease requiring systemic immunosuppression, except limited replacement-dose steroids or protocol-permitted topical\u002Finhaled therapy.\n* Prior solid organ transplant.\n* Clinically significant cardiovascular disease, uncontrolled arrhythmia, decompensated heart failure, myocardial infarction within 6 months, or recent stroke within 6 months.\n* Uncontrolled HIV, HBV, or HCV viremia.\n* Pregnancy or breastfeeding.\n* Another active malignancy requiring systemic therapy, unless low-risk and definitively treated per protocol-defined exceptions.\n* Known hypersensitivity to fludarabine, cyclophosphamide, or critical product excipients.\n* Inability to manufacture a releaseable CAR-T product or failure to meet module-specific product-release criteria.\n* Any medical, psychiatric, or social condition that, in the investigator's judgment, would increase risk, impair compliance, or confound interpretation of study results.","ALL","18 Years","75 Years",{"count":124,"type":125},96,"ESTIMATED","INTERVENTIONAL",[128,129],"PHASE1","PHASE2","Phase 1\u002F2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies. After central antigen co-expression screening, participants are assigned to the most appropriate active dual-target module: CD19\u002FCD22, CD19\u002FCD20, BCMA\u002FCD19, BCMA\u002FCD38, BCMA\u002FGPRC5D, CD33\u002FCD123, CD33\u002FCLL1, or CD5\u002FCD7. Phase 1 determines safety, dose-limiting toxicities, and the recommended phase 2 dose for each module; phase 2 estimates preliminary antitumor activity, including overall response rate and MRD-negative response.\n\nLymphodepletion with fludarabine\u002Fcyclophosphamide precedes infusion. The design is intended to reduce antigen escape by matching disease biology and target co-expression to a rational dual-target strategy.",[132,133,134,135,136,137,138],"Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia","Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma or CLL\u002FSLL","Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","Relapsed\u002FRefractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm","BPDCN; Relapsed\u002FRefractory T-cell Acute Lymphoblastic Leukemia","T-lymphoblastic Lymphoma","Peripheral T-cell Lymphoma",[140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156],"BCMA","biomarker-selected","CD19","CD20","CD22","CD33","CD38","CD123","CD5","CD7","CLL1\u002FCLEC12A","dual-target CAR-T","GPRC5D","hematologic malignancy","MRD negativity","antigen escape","umbrella trial","2026-04-05",{"date":159,"type":160},"2026-04-13","ACTUAL",{"date":162,"type":160},"2026-03-02",{"date":164,"type":125},"2028-02-17",{"name":5,"class":6},1]