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.
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
None
Single group
CD22 CAR-T cells
Other interventionCD22 CAR-T cells
Safety Evaluation: Treatment Related Toxicities
An evaluation of safety of the use of autologous anti-CD22 CAR T cells (SHB-04-CD22) manufactured at the Sheba Medical Center, in patients with relapsed/refractory B-cell malignancies. Safety will be determined by evaluation of participants with treatment-related adverse events, as assessed by CTCAE 5.0.
Efficacy Evaluation
An evaluation of the feasibility and efficacy of administering anti-CD22-CAR T cells (SHB-04-CD22) in patients with B-cell malignancies at the Sheba Medical Center. Efficacy will be determined by an evaluation of disease response in participants post treatment. Disease response will be assessed by blasts percentage in bone marrow for ALL patients and by PET-CT scan based on the Lugano classification for NHL patients.
Minimal toxic dose evaluation
An evaluation of the minimal toxic dose of CD22 CAR-T cells (SHB-04-CD22). This will be determined by evaluation of participants with treatment-related adverse events, as assessed by CTCAE 5.0, and according to different dose levels administered.
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