NCT07135466RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 2 Jul 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Sheba Medical Center
- Diseases
- Childhood cancers
- NCT number
- NCT07135466
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 50
- From 1 Feb 2026 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 1 year to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.