Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies

Recruiting now · Phase 1/Phase 2

Conditions studied: Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia, Relapsed/Refractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm, BPDCN; Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia, T-lymphoblastic Lymphoma, Peripheral T-cell Lymphoma

In brief

Phase 1/2 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/CD22, CD19/CD20, BCMA/CD19, BCMA/CD38, BCMA/GPRC5D, CD33/CD123, CD33/CLL1, or CD5/CD7. 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. Lymphodepletion with fludarabine/cyclophosphamide precedes infusion. The design is intended to reduce antigen escape by matching disease biology and target co-expression to a rational dual-target strategy.

Key facts

Study ID

NCT07523555

Run by

Beijing Biotech

People needed

96

Starts

2026-03-02

Expected to finish

2028-02-17

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 75 years at the time of consent.
• Pathologically or cytologically confirmed eligible disease: B-ALL; B-cell NHL/CLL/SLL; multiple myeloma/plasma cell leukemia; AML/high-risk MDS/BPDCN; or T-ALL/T-LBL/peripheral T-cell lymphoma.
• Relapsed or refractory disease after at least 2 prior lines of therapy, or no curative/approved standard option judged appropriate by the investigator.
• Central laboratory confirmation that at least one active dual-target module is suitable based on malignant-cell antigen co-expression and safety review.
• Measurable or otherwise evaluable disease by disease-specific response criteria.
• ECOG performance status 0 to 2.
• Adequate organ function: LVEF >= 45%; creatinine clearance >= 40 mL/min; AST/ALT <= 3 x ULN; total bilirubin <= 1.5 x ULN unless due to Gilbert syndrome; oxygen saturation >= 92% on room air.
• Adequate hematologic reserve unless cytopenia is clearly disease-related.
• Ability to undergo leukapheresis and willingness to comply with study procedures and follow-up.
• If prior allogeneic HSCT: at least 100 days from transplant, no uncontrolled GVHD, and no systemic immunosuppression above physiologic steroid replacement.
• Negative pregnancy test for participants of childbearing potential and agreement to use effective contraception during protocol-defined risk periods.
• Written informed consent obtained before any study-specific procedure.

You may not qualify if…

• - Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection, or clinical sepsis.
• Active symptomatic CNS involvement requiring escalating therapy; previously treated/stable CNS disease may be allowed if defined prospectively in the final protocol.
• Prior gene-modified cellular therapy within 12 weeks before leukapheresis, or unresolved >= Grade 3 toxicity from prior anticancer therapy
• Need for urgent cytoreduction such that manufacturing delay would create unacceptable clinical risk.
• Active autoimmune disease requiring systemic immunosuppression, except limited replacement-dose steroids or protocol-permitted topical/inhaled therapy.
• Prior solid organ transplant.
• Clinically significant cardiovascular disease, uncontrolled arrhythmia, decompensated heart failure, myocardial infarction within 6 months, or recent stroke within 6 months.
• Uncontrolled HIV, HBV, or HCV viremia.
• Pregnancy or breastfeeding.
• Another active malignancy requiring systemic therapy, unless low-risk and definitively treated per protocol-defined exceptions.
• Known hypersensitivity to fludarabine, cyclophosphamide, or critical product excipients.
• Inability to manufacture a releaseable CAR-T product or failure to meet module-specific product-release criteria.
• Any medical, psychiatric, or social condition that, in the investigator's judgment, would increase risk, impair compliance, or confound interpretation of study results.

Where it is running

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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