Dual-Target CAR-T Cell Therapy for Adults With Relapsed or Hard-to-Treat Blood Cancers
Tests CAR-T cells aimed at two targets in adults with returned blood cancers.
Plain-language title generated from the registry record
Registry title: Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07523555, who can take part
Where in China
- Peking University Shenzhen HospitalShenzhen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Biotech
- Trial code
- NCT07523555
- Record updated
- 13 April 2026
- Original description
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.Read full original descriptionShow less
A Phase 1/2, Open-Label, Nonrandomized, Multi-arm Umbrella Study of Biomarker-Selected Dual-Target CAR-T Cell Modules in Adults With Relapsed or Refractory Hematologic Malignancies
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.
Inclusion: 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.
Exclusion: 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; Prior solid organ transplant; - Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection, or clinical sepsis; Active autoimmune disease requiring systemic immunosuppression, except limited replacement-dose steroids or protocol-permitted topical/inhaled therapy; 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; 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; Need for urgent cytoreduction such that manufacturing delay would create unacceptable clinical risk; Pregnancy or breastfeeding.