At a glance
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A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies
In Brief
A Phase 1 clinical trial evaluating Therapeutic 4SCAR19 cells for B-cell Malignancies. Currently recruiting, targeting 200 participants across 1 site.
Detailed Summary
The study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
Study Details
Timeline
Arms & Interventions
Patients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells.
Interventions
Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19