CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CD19/CD22-bispecific CAR-T cells.
- Who it may be relevant to
- Registry conditions: B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma, Diffuse Large B Cell Lymphoma. Basic parameters: 14 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia: a Prospective, Single-arm, Single-center, Phase 2 Clinical Trial
Overview
CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, we supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B-ALL or NHL. In this prospective phase 2 clinical trial, we aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory B-ALL or Large B cell lymphoma.
Interventions
- Drug CD19/CD22-bispecific CAR-T cells
CD19/CD22-bispecific CAR-T cells were infused at the same day with 2×10e6/kg and 1×10e6/kg dosage, respectively.
Primary outcome measures
- Best ORR [Time frame: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion]
Secondary outcome measures (3)
- Best CR rate [Time frame: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion]
- Progression free survival (PFS) [Time frame: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion]
- overall survival (OS) [Time frame: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion]
Eligibility criteria
Inclusion criteria
- 14 years to 85 years, expected survival > 3 months;
- CD19/CD22 positive B-cell lymphoma or B-ALL;
- relapsed or refractory to standard first-line treatment;
- ECOG-PS score=0-2;
- Having at least one measurable lesions;
- Cardiac function: 1-2 levels;
- Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN;
- kidney: Cr≤1.25ULN;
- bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L;
- No serious allergic constitution;
- No other serious diseases that conflicts with the clinical program;
- No other cancer history;
- No serious mental disorder;
- Informed consent is signed by a subject or his lineal relation.
Exclusion criteria
- Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B or hepatitis C infection;
- Recent or current use of glucocorticoid or other immunosuppressor;
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- Participate in other clinical research in the past three months;
- previously treatment with any gene therapy products;
- Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Liang Wang — Beijing
Identifiers
NCT: NCT06081478 · CAR-T001/TR