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

CAR-T001/TR

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.

2022-01-18

2025-12-31

2026-12-31

Recruiting

Early phase I

100

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-10-13