Actively Recruiting
Exploratory Study of CD22/CD19 Dual-Target CAR-T Cell Therapy as Consolidation Treatment After First Remission in High-Risk B-Cell Acute Lymphoblastic Leukemia
Led by Liping Dou · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-center, open-label, single-arm, prospective study will evaluate the safety, tolerability, and efficacy of CD22/CD19 dual-target CAR-T cell therapy as consolidation treatment in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) who have achieved first remission after standard induction therapy and consolidation chemotherapy. Approximately 30 patients will be enrolled. Participants will undergo screening, cell collection for CAR-T manufacturing, lymphodepleting chemotherapy, and subsequent CAR-T cell infusion, followed by scheduled safety and efficacy follow-up. Safety assessments will include monitoring for cytokine release syndrome, neurotoxicity, hematologic toxicity, organ toxicity, infections, and other adverse events. Efficacy assessments will include event-free survival, overall survival, progression-free survival, duration of response, relapse, and mortality. Exploratory analyses will assess CAR-T cell kinetic characteristics and clonal evolution after treatment.
CONDITIONS
Official Title
Exploratory Study of CD22/CD19 Dual-Target CAR-T Cell Therapy as Consolidation Treatment After First Remission in High-Risk B-Cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and able to follow study procedures including visits and tests
- Diagnosed with B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL) according to WHO 2022 criteria, with CD19-positive and/or CD22-positive disease
- Achieved first complete remission (CR1) after standard induction chemotherapy with bone marrow blasts less than 5%
- Eligible for enhanced consolidation therapy due to high-risk disease or persistent minimal residual disease after consolidation
- Unwilling or ineligible for allogeneic hematopoietic stem cell transplantation and planned to receive CAR-T therapy
- Age between 18 and 85 years
- ECOG performance status of 0 to 2
- Estimated life expectancy of at least 3 months
- Hemoglobin level at least 60 g/L (transfusion allowed)
- Absolute neutrophil count at least 1,000/µL and platelet count at least 45,000/µL
- Adequate organ function including specified limits for bilirubin, liver enzymes, kidney function, heart function, oxygen saturation, and no significant effusions
- Subjects of reproductive potential must agree to effective contraception from enrollment until 6 months after study completion
You will not qualify if you...
- Relapsed or refractory B-ALL or patients planned for allogeneic stem cell transplant or CD19/CD3 bispecific antibody therapy who refuse CAR-T consolidation
- Early relapse within 6 months after first complete remission
- Primary refractory disease after two cycles of induction chemotherapy
- Failure to achieve remission or relapse after salvage chemotherapy
- Relapse after allogeneic stem cell transplantation
- Prior CAR-T or genetically modified T-cell therapy
- Known HIV infection, active hepatitis B infection, or uncontrolled active systemic infection needing IV antibiotics
- Non-disease-related severe liver or kidney dysfunction beyond specified limits
- Significant cardiovascular disease within 12 months prior to enrollment
- Severe or uncontrolled medical conditions interfering with participation
- History of severe immediate allergic reactions to study drugs or related agents
- Pregnant or breastfeeding women
- Unable or unwilling to comply with study procedures or poor adherence
- History of other cancers unless disease-free for at least 3 years (except treated non-melanoma skin cancer or carcinoma in situ)
- Receipt of live vaccines within 6 weeks before lymphodepleting chemotherapy
- Major surgery within 14 days before enrollment or planned during study
- Any other condition increasing risk or interfering with study per investigator judgment
AI-Screening
AI-Powered 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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