Tests CD22 CAR-T cells in people with CD22-expressing B-cell cancers
Tests modified T cells targeting CD22 in children and adults with returned B-cell cancers.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Ramat Gan, IsraelSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 80 years old?
Source: NCT07135466, who can take part
Where in Israel
- Sheba medical centerRamat Gan, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sheba Medical Center
- Trial code
- NCT07135466
- Record updated
- 16 January 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.