NCT07135466 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
| NCT ID | NCT07135466 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sheba Medical Center |
| Condition | B Cell Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2026-02-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Prof. Elad Jacoby, MD
PRINCIPAL INVESTIGATOR
Sheba Medical Center
Frequently Asked Questions
Who can join the NCT07135466 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 80 Years, studying B Cell Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07135466 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07135466 currently recruiting?
Yes, NCT07135466 is actively recruiting participants. Contact the research team at sivan.yakobi@sheba.health.gov.il for enrollment information.
Where is the NCT07135466 trial being conducted?
This trial is being conducted at Ramat Gan, Israel.
Who is sponsoring the NCT07135466 clinical trial?
NCT07135466 is sponsored by Sheba Medical Center. The principal investigator is Prof. Elad Jacoby, MD at Sheba Medical Center. The trial plans to enroll 50 participants.