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
Recruiting now · Phase 1/Phase 2
Conditions studied: B Cell Malignancies
In brief
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.
Key facts
- Study ID
- NCT07135466
- Run by
- Sheba Medical Center
- People needed
- 50
- Starts
- 2026-02-01
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-01-16
Who can join
Age: 1 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient must have a CD22-expressing hematologic malignancy, relapsed or refractory after receiving at least 2 lines of standard therapy including CD19-directed therapy (For CD19 positive disease):
- Relapse following standard relapse protocol (2nd relapse), including CD19 CART.
- Primary refractory, i.e. failed to achieve morphologic remission after 2 lines of induction chemotherapy.
- Age 1-80 years
- CD22 expression shown by flow cytometry on at least 70% of leukemic blasts / lymphoma cells
- Adequate CD3 count (above 120 CD3+ cells per microliter blood)
- Clinical performance status: Patients > 10 years of age: Karnofsky ≥ 50%; Patients ≤ 10 years of age: Lansky scale ≥ 50%. Exception for neurologic symptoms (e.g. paralysis) that are explained by the malignancy.
- Females of child-bearing potential must have a negative pregnancy test
- Cardiac function: LV ejection fraction >45% or shortening fraction >28%
- At least 60 days after autologous or allogeneic BMT
- At least 30 days after prior CAR therapy in absence of response
Where it is running
- Sheba Medical Center — Ramat Gan, G, Israel (enrolling)
Full record on ClinicalTrials.gov
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