RecruitingPhase 1Phase 2NCT07135466

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


Sponsor

Sheba Medical Center

Enrollment

50 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 1 YearMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of CAR-T cell therapy — where a patient's own immune T-cells are re-engineered to recognize and attack a protein called CD22 — in people with blood cancers (leukemia or lymphoma) that have stopped responding to other treatments, including prior CD19-targeted therapies. **You may be eligible if...** - You are between 1 and 80 years old - You have a blood cancer (leukemia or lymphoma) that expresses CD22 on at least 70% of cancer cells - Your cancer has come back or did not respond to at least 2 prior treatment lines, including a CD19-directed therapy - You have adequate immune cell counts (CD3 T-cells above 120 per microliter) - You are in reasonably functional health (Karnofsky ≥50% for adults; Lansky ≥50% for children) **You may NOT be eligible if...** - Your cancer does not express CD22 - You have had only one prior line of therapy - You have significant organ dysfunction making this therapy unsafe - You have active brain or spinal involvement by the cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCD22 CAR-T cells

CD22 CAR-T cells


Locations(1)

Sheba Medical Center

Ramat Gan, G, Israel

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NCT07135466


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