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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06081478 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gene therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Does this trial require CD22?
Yes, CD22 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 85 years or younger and at least 14 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify