Anti-CD22 CAR‑T cell therapy for CD22‑positive B‑cell cancers
Official title: 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
Run by Sheba Medical Center · NCT07135466 · Data updated 2026-11-12
This trial will try a one-time CAR‑T cell therapy that targets CD22 in children and adults whose relapsed or refractory B‑cell cancers still express CD22 after prior treatments, including CD19‑directed therapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 80 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Sheba Medical Center Government |
| Drugs / interventions | CART, chemotherapy, CAR-T, CAR T, immunotherapy |
| Locations | 1 site (Ramat Gan, G) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | January 1, 2028 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT07135466 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children or adults (age 1–80) with relapsed or refractory CD22‑expressing B‑cell malignancies (≥70% CD22 on tumor cells), who have had at least two prior therapies including CD19‑directed treatment when applicable, and meet blood count, cardiac, and performance‑status requirements.
✕Probably not a fit
Patients whose tumors do not express CD22 at the required level, those with inadequate T‑cell counts for manufacturing, severe uncontrolled medical conditions, or who cannot travel to Sheba Medical Center are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open‑label, single‑arm phase 1/2 trial collects a patient's own T cells by apheresis, engineers them with a retroviral anti‑CD22 chimeric antigen receptor at Sheba's Advanced Biotherapy Center, and returns the modified cells as a one‑time infusion. The study enrolls pediatric and adult patients (age 1–80) with relapsed or refractory CD22‑expressing B‑cell malignancies who have received at least two prior lines of therapy including CD19‑directed therapy when applicable. Key eligibility includes ≥70% CD22 expression on malignant cells, adequate CD3 count, and minimum cardiac and performance‑status criteria. Patients will be monitored closely for response and for known CAR‑T toxicities such as cytokine release syndrome and neurotoxicity.
Why it matters
Potential benefit: If successful, the anti‑CD22 CAR‑T could produce remissions in patients who have relapsed after CD19 therapies by targeting a different B‑cell antigen.
How similar studies have gone: Earlier CD22‑targeted CAR‑T programs have shown clinical responses, particularly in ALL and in some CD19‑negative relapses, but remissions have sometimes been short or limited by antigen loss.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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's running
-
Sheba Medical Center
Ramat Gan, G, Israel Recruiting
Study contacts
- Principal investigator: Prof. Elad Jacoby, MD — Sheba Medical Center
- Study coordinator: Sivan Yakobi
- Email: sivan.yakobi@sheba.health.gov.il
- Phone: 972 03 5309046
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.