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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a blood cancer that came back or did not respond to treatment, and whose cancer cells carry the right pair of target markers for a CAR-T cell treatment.
- Age
- 18 to 75 years
- Sex
- Men and women
- Disease stage
- Relapsed or refractory B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin lymphoma, CLL/SLL, multiple myeloma, plasma cell leukemia, AML, high-risk MDS, BPDCN, T-ALL, T-lymphoblastic lymphoma or peripheral T-cell lymphoma, with disease that can be measured or evaluated.
- Earlier treatment
- At least 2 earlier lines of treatment, or no standard option the investigator judges appropriate. No gene-modified cell therapy within 12 weeks before leukapheresis. After an earlier donor stem cell transplant, at least 100 days must have passed, with no uncontrolled GVHD.
- Biomarker or test result
- A central lab must confirm that the cancer cells carry the target markers of at least one dual-target CAR-T module (CD19/CD22, CD19/CD20, BCMA/CD19, BCMA/CD38, BCMA/GPRC5D, CD33/CLL1, CD33/CD123 or CD5/CD7).
Main reasons for not taking part
- Active uncontrolled infection
- Active symptomatic cancer in the central nervous system (CNS) that needs stronger treatment
- Earlier solid organ transplant
- Pregnancy or breastfeeding
- Uncontrolled HIV, HBV or HCV viremia
Read by machine on 9 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.