Actively Recruiting
Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
Led by Beijing Biotech · Updated on 2026-04-13
96
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at consent
- Confirmed diagnosis of eligible blood cancers including 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
- Disease that is relapsed or refractory after at least two prior treatments or no appropriate standard option
- Central lab confirmation that at least one dual-target module matches malignant-cell antigen expression
- Measurable or evaluable disease by disease-specific criteria
- ECOG performance status 0 to 2
- Adequate organ function including LVEF ≥ 45%, creatinine clearance ≥ 40 mL/min, AST/ALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN unless Gilbert syndrome, and oxygen saturation ≥ 92% on room air
- Adequate blood cell counts unless cytopenia is due to disease
- Ability to undergo leukapheresis and willingness to follow study procedures
- If prior allogeneic stem cell transplant, at least 100 days post-transplant with no uncontrolled graft-versus-host disease and no systemic immunosuppression above physiologic steroid replacement
- Negative pregnancy test for those who can become pregnant and agreement to use contraception during risk periods
- Provided written informed consent before any study procedures
You will not qualify if you...
- Active uncontrolled infections including bacterial, fungal, viral infections, or sepsis
- Active symptomatic central nervous system involvement needing escalating treatment; stable treated CNS disease may be allowed if defined
- Previous gene-modified cellular therapy within 12 weeks or unresolved Grade 3 or higher toxicity from prior cancer therapy
- Need for urgent cytoreduction that would risk delay in manufacturing
- Active autoimmune disease requiring systemic immunosuppression beyond limited steroids or permitted topical/inhaled therapy
- Prior solid organ transplant
- Significant cardiovascular disease, uncontrolled arrhythmia, decompensated heart failure, recent myocardial infarction or stroke within 6 months
- Uncontrolled HIV, HBV, or HCV infection
- Pregnancy or breastfeeding
- Another active cancer requiring systemic therapy unless low-risk and definitively treated as per protocol
- Known allergy to fludarabine, cyclophosphamide, or key product ingredients
- Inability to produce a releaseable CAR-T product or failure to meet product release criteria
- Any medical, psychiatric, or social condition judged by the investigator to increase risk, impair compliance, or affect study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
shan S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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