What is the anti-CD22 CAR-T cell therapy studying for B-cell malignancies?

This trial studies T-cells modified to target CD22, a marker on some B-cell cancers, to evaluate safety and effectiveness in patients whose disease has returned or not responded to other treatments, including CD19 therapies. The research is sponsored by Sheba Medical Center and focuses on both children and adults with these blood cancers.

Who may be eligible for this B-cell malignancy clinical trial?

Patients aged 1 to 80 years with CD22-expressing blood cancers that have relapsed or are refractory after at least two standard treatments including CD19 therapies may be eligible. They must have adequate T-cell counts and heart function, and females of childbearing potential must test negative for pregnancy. Please review eligibility criteria for more details.

Is there any cost to participate in this B-cell malignancy clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 1Year - 80Years

All Genders

ID07135466

Phase 12 Study of Anti-CD22 CAR-T Cell Therapy SHB-04-CD22 for Patients Aged 1 to 80 With CD22-Expressing B-cell Cancers

Led by Sheba Medical Center · Updated on 2026-01-16

Participants Needed

Research Sites

39 weeks

Total Duration

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 12 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

Age: 1Year - 80Years

All Genders

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

Research Team

Sivan Yakobi

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Phase 12 Study of Anti-CD22 CAR-T Cell Therapy SHB-04-CD22 for Patients Aged 1 to 80 With CD22-Expressing B-cell Cancers

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria