Actively Recruiting
Targeted CD22/CD19 CAR-T Therapy for Consolidation in Standard-Risk B-ALL
Led by Liping Dou · Updated on 2026-05-08
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, open-label, single-arm prospective study designed to evaluate the safety, tolerability, and efficacy of dual-target CD22/CD19 chimeric antigen receptor (CAR)-T cell therapy as consolidation treatment in patients with standard-risk B-cell acute lymphoblastic leukemia (B-ALL) in remission. Eligible patients will undergo leukapheresis for CAR-T cell manufacturing, followed by lymphodepleting chemotherapy and CAR-T cell infusion. Patients will be closely monitored for safety, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicity, and infections. Efficacy endpoints include event-free survival (EFS), overall survival (OS), progression-free survival (PFS), relapse rate, and mortality. Exploratory analyses will assess CAR-T cell expansion kinetics and clonal evolution. The total follow-up duration is planned to be 2 years.
CONDITIONS
Official Title
Targeted CD22/CD19 CAR-T Therapy for Consolidation in Standard-Risk B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who provide written informed consent and can comply with study procedures
- Diagnosis of B-cell acute lymphoblastic leukemia/lymphoma with CD19-positive and/or CD22-positive disease
- Achieved first morphological complete remission after standard induction chemotherapy
- Adults aged 18 to 85 years
- Standard-risk B-ALL patients without high-risk features who have completed two cycles of intensive consolidation chemotherapy
- Sustained bone marrow and molecular minimal residual disease negativity
- ECOG performance status 0-2
- Estimated life expectancy of at least 3 months
- Hemoglobin level at least 60 g/L (transfusion allowed)
- Absolute neutrophil count of at least 1,000/µL and platelet count of at least 45,000/µL
- Adequate organ function including liver, kidney, heart, and lung parameters
- Agreement to use effective contraception during and for 6 months after the study if of reproductive potential
You will not qualify if you...
- Relapsed or refractory B-cell acute lymphoblastic leukemia or high-risk patients planned for stem cell transplant or bispecific antibody therapy
- Early relapse within 6 months after first remission
- Primary refractory disease after two induction chemotherapy cycles
- Failure to achieve remission or relapse after salvage chemotherapy
- Relapse after allogeneic stem cell transplant
- Persistent minimal residual disease positivity with high relapse risk
- Prior CAR-T or genetically modified T-cell therapy
- Known HIV infection, active hepatitis B infection, or uncontrolled systemic infections
- Significant liver or kidney dysfunction outside disease-related causes
- Cardiovascular disease within the past 12 months
- Severe or uncontrolled medical conditions affecting participation
- History of severe allergic reactions to study treatments
- Pregnant or breastfeeding women
- Inability or unwillingness to comply with study procedures
- History of other cancers unless disease-free for at least 3 years
- Receipt of live vaccines within 6 weeks before chemotherapy
- Major surgery within 14 days before enrollment or planned during the study
- Any other condition judged by the investigator to increase risk or interfere with study results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
L
Li-Ping Dou, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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