OncoMatch/Clinical Trials/NCT06081478
CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia
Is NCT06081478 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies CD19/CD22-bispecific CAR-T cells for b-cell acute lymphoblastic leukemia.
Treatment: CD19/CD22-bispecific CAR-T cells — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: CD19 positive
Required: CD22 positive
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard first-line treatment
relapsed or refractory to standard first-line treatment
Cannot have received: gene therapy
previously treatment with any gene therapy products
Lab requirements
Blood counts
WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L
Kidney function
Cr≤1.25ULN
Liver function
TBIL≤3ULN,AST ≤2.5ULN,ALT ≤2.5ULN
Cardiac function
Cardiac function: 1-2 levels
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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