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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.

Phase 2RecruitingBeijing Tongren HospitalNCT06081478Data as of May 2026

Treatment: CD19/CD22-bispecific CAR-T cellsCAR-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.

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Extracted 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

Min 1 prior line

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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