Actively Recruiting
Phase 1/2 Study of Biomarker-Selected Dual-Target CAR-T Cell Modules for Adults With Relapsed or Refractory Hematologic Malignancies
Led by Beijing Biotech · Updated on 2026-04-13
96
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating dual-target CAR-T cell therapies in adults with relapsed or refractory blood cancers. This Phase 1/2 umbrella study assigns participants to different CAR-T modules based on the presence of specific antigen combinations on their malignant cells to reduce the chance of the cancer escaping treatment. The study aims to determine the safety, recommended dose, and initial antitumor activity of each dual-target module while matching treatment to disease biology. Participants undergo screening including bone marrow and blood tests to identify the best CAR-T module from options like CD19/CD22, CD19/CD20, BCMA/CD19, and others. Treatment includes leukapheresis to collect cells, optional bridging therapy, lymphodepletion with fludarabine and cyclophosphamide, followed by infusion of the selected dual-target CAR-T cells. Different modules may be given as tandem or sequential infusions depending on safety and manufacturing needs. During the study, participants are closely monitored for safety through the first 28 days, then followed for efficacy up to 24 months. Assessments include response rates, minimal residual disease negativity, duration of response, and survival. Long-term safety follow-up of gene-modified cells may continue up to 15 years. Participants must comply with study visits and procedures including blood tests, imaging, and clinical evaluations throughout this period.
CONDITIONS
Brief 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 the time of 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
- Relapsed or refractory disease after at least two prior treatments or no suitable standard therapy
- Central lab confirmation of eligible dual-target antigen expression on malignant cells
- Measurable or evaluable disease by disease-specific criteria
- ECOG performance status between 0 and 2
- Adequate organ function including LVEF ≥ 45%, creatinine clearance ≥ 40 mL/min, AST/ALT ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (except Gilbert syndrome), oxygen saturation ≥ 92% on room air
- Adequate blood cell counts unless due to disease
- Ability to undergo leukapheresis and comply with study procedures and follow-up
- If prior allogeneic stem cell transplant, at least 100 days post-transplant without uncontrolled graft-versus-host disease or high immunosuppression
- Negative pregnancy test if applicable and agreement to use effective contraception
- Written informed consent obtained before any study-specific procedure
You will not qualify if you...
- Active uncontrolled infection including bacterial, fungal, viral infections, or sepsis
- Active symptomatic central nervous system involvement requiring increasing therapy
- Prior gene-modified cell therapy within 12 weeks or unresolved grade 3 or higher toxicity from prior cancer treatment
- Need for urgent cytoreduction that would delay manufacturing and pose clinical risk
- Active autoimmune disease needing systemic immunosuppression beyond limited steroids or permitted therapies
- Prior solid organ transplant
- Significant cardiovascular disease such as uncontrolled arrhythmia, heart failure, recent heart attack or stroke within 6 months
- Uncontrolled HIV, hepatitis B or C infection
- Pregnancy or breastfeeding
- Another active cancer requiring systemic therapy unless low-risk and treated
- Known allergy to fludarabine, cyclophosphamide, or critical product components
- Inability to produce CAR-T product meeting release criteria
- Any medical, psychiatric, or social condition increasing risk or impairing study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 3 weeks
Participants are screened for eligibility to participate in the trial.
1 to 3 visits for central immunophenotyping on bone marrow, peripheral blood, and/or involved tissue
Duration - Day 0 with monitoring through Day 28
Participants undergo leukapheresis, optional bridging therapy, lymphodepletion with fludarabine and cyclophosphamide, followed by infusion of the selected dual-target CAR-T module.
1 leukapheresis visit, 1 to 2 visits for lymphodepletion, 1 infusion visit, and intensive monitoring visits through Day 28
Duration - Up to 24 months for efficacy follow-up; up to 15 years for long-term safety follow-up if applicable
Participants are followed for efficacy assessments through Month 24 and may enter long-term gene-modified cell safety follow-up for up to 15 years if required.
Regular visits for efficacy assessments through 24 months; additional long-term safety visits as required
Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
shan S Lu, Phd
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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