OncoMatch/Clinical Trials/NCT07135466
A Phase 1/2 Study of T-cell Expressing an Anti-CD22 Chimeric-Antigen Receptor (SHB-04-CD22) in Patients With CD22-expressing B-cell Malignancies
Is NCT07135466 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies non-drug interventions for b cell malignancies.
This is a phase I/II trial of T-cell expressing an anti-CD22 Chimeric-Antigen-Receptor (CAR) in patients with CD22 expressing B-cell malignancies. This trial is an open label, single-arm, for pediatric and adult patients with relapsed/refractory B-cell malignancies.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CD22 expression (expression shown by flow cytometry on at least 70% of leukemic blasts / lymphoma cells)
CD22 expression shown by flow cytometry on at least 70% of leukemic blasts / lymphoma cells
Allowed: CD19 positive disease
including CD19-directed therapy (For CD19 positive disease)
Prior therapy
Must have received: CD19-directed therapy
relapsed or refractory after receiving at least 2 lines of standard therapy including CD19-directed therapy (For CD19 positive disease)
Must have received: CAR-T cell therapy
Relapse following standard relapse protocol (2nd relapse), including CD19 CART
Must have received: induction chemotherapy
Primary refractory, i.e. failed to achieve morphologic remission after 2 lines of induction chemotherapy
Lab requirements
Cardiac function
LV ejection fraction >45% or shortening fraction >28%
Cardiac function: LV ejection fraction >45% or shortening fraction >28%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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