Actively Recruiting
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
Led by Sheba Medical Center · Updated on 2026-01-16
50
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment using T-cells engineered to target CD22 in patients with B-cell malignancies that express this marker. This phase 1/2 open-label trial focuses on both pediatric and adult patients who have relapsed or refractory B-cell cancers after receiving at least two prior standard therapies, including treatments targeting CD19. The study aims to assess the safety and effectiveness of this anti-CD22 CAR-T therapy, as current CD19-targeted treatments often result in relapse. Participants will undergo a one-time collection of their own T cells through apheresis. These cells are then modified in the laboratory to express a chimeric antigen receptor (CAR) that recognizes CD22. Patients receive lymphodepleting chemotherapy before a single infusion of the CD22 CAR-T cells. The study includes a dose escalation phase with three dose levels to determine the safest and most effective dose, followed by a dose expansion phase at the recommended dose. During the trial, participants will be closely monitored for about three months after treatment to evaluate safety and response. Assessments will include blood tests, genetic testing, and disease evaluations. Long-term monitoring for survival and health outcomes will continue annually for up to 15 years. The primary outcomes focus on treatment-related toxicities, efficacy, and minimal toxic dose within specified timeframes after treatment.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with CD22-expressing blood cancers who have relapsed or are refractory after at least two standard treatments, including CD19-directed therapy
- Relapse following standard relapse protocol (second relapse), including after CD19 CAR-T therapy
- Primary refractory disease with failure to achieve remission after two induction chemotherapies
- Age between 1 and 80 years
- CD22 expression on at least 70% of leukemic or lymphoma cells confirmed by flow cytometry
- Adequate CD3+ T-cell count above 120 cells per microliter of blood
- Clinical performance status: Karnofsky score 50% or higher for patients over 10 years old; Lansky score 50% or higher for patients 10 years old or younger, except for neurologic symptoms related to malignancy
- Negative pregnancy test for females of child-bearing potential
- Normal heart function with left ventricular ejection fraction above 45% or shortening fraction above 28%
- At least 60 days since autologous or allogeneic bone marrow transplant
- At least 30 days since prior CAR therapy without response
You will not qualify if you...
- Patients not meeting the inclusion criteria
- Pregnancy or positive pregnancy test in females of child-bearing potential
- Inadequate heart function below specified thresholds
- Insufficient CD3+ T-cell count
- Performance status below required levels
- Less than required time elapsed since bone marrow transplant or prior CAR therapy
- Patients with non-CD22-expressing malignancies or without relapsed/refractory disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment event with monitoring up to 3 months post treatment
Participants receive lymphodepleting chemotherapy followed by a single dose of CD22 CAR-T cells (SHB-04-CD22).
1 apheresis visit, 1 lymphodepleting chemotherapy visit, 1 CAR-T cell infusion visit, and weekly visits for up to 12 weeks
Duration - Approximately 3 months
Participants are closely monitored for safety and response to treatment after receiving CD22 CAR-T cells.
Weekly visits for up to 12 weeks
Duration - Once a year for 15 years
Participants undergo yearly assessments to monitor long-term survival and health status.
1 visit annually
Trial Site Locations
Total: 1 location
1
Sheba Medical Center
Ramat Gan, G, Israel
Actively Recruiting
Research Team
S
Sivan Yakobi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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