Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I/II Study of Competitive Transfer of αCD19-TCRz-CD28 and αCD19-TCRz-CD137 Chimeric Antigen Receptor T-Cells in Patients With Refractory CD19+ B-lineage Leukemia/Lymphoma
This is a single-arm open-label phase I/II study to determine the relative superiority of αCD19-TCRζ-CD28 and αCD19-TCRζ-CD137 CAR-T Cells in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. In this trial, all subjects will be competitively infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells in equal number to test a hypothesis that CD137-costimulation can promote the persistence and engraftment of CAR-T cells and this superiority can lead to improved progression-free survival.
Primary objectives
1. To determine the safety and feasibility of adoptive transfer of T cells modified to
express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and
lymphoma
Secondary objectives
1. To measure the efficacy of anti-tumor responses after CD19CAR T cell infusion
2. To determine if CD19CAR T cells engineered with 4-1BB signaling domain is superior to
that with CD28 signaling domain for their homing and persistence after CD19CAR T cell
infusion
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
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