Study Summary
This is a phase I/II trial of SHB-02-CD19, T-cell expressing an anti-CD19 Chimeric-Antigen-Receptor (CAR) in patients with CD19 expressing B-cell malignancies. This trial is an open label, single-arm, for pediatric and adult patients with relapsed/refractory B-cell malignancies.
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Request More InfoInterventions
SHB-02-CD19 (anti CD19 CAR-T cells)DRUG
Phase 1 of this study includes a dose escalation plan of SHB-02-CD19. Treatment will start at dose level 1. According to safety assessments, dose will increase to next dose level.
Dose level 1: 0.25x10\^6 CAR+ T cells per kilogram Dose level 2: 0.5x10\^6 CAR+ T cells per kilogram Dose level 3: 1x10\^6 CAR+ T cells per kilogram Phase 2 of this study will be a dose expansion phase of the dose recommended based on safety and expected efficacy.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Sheba Medical Center | Ramat Gan | Israel |