Safety and Efficacy of iPD1 CD19 eCAR T Cells in Relapsed or Refractory B-cell Lymphoma
Summary
PD1 pathway is critical in determining the response to CAR T cell therapy. Emerging data suggested that Inhibition of PD1 could enhance the efficacy of CAR T cell therapy. iPD1 CD19 eCAR T cells is an enhanced version of the classical 2nd generation anti-CD19 4-1BB-costimulatory chimeric antigen receptor engineered T cells with cell-intrinsic PD1 inhibition by incorporation of a PD1 shRNA-expressing cassette in the CAR lentivector. This design will enhance the anti-tumor activities of CAR T cells by inhibiting PD1 induction after CAR T cell activation. This pilot, single arm, one center, dose-escalation, open label study is to determine the safety and efficacy of iPD1 CD19 eCAR T cells in relapsed or refractory CD19 positive lymphoma. Subjects will be given a lymphodepletion chemotherapy comprised of Fludarabine and cyclophosphamide prior to CAR T cell infusion. The chemotherapy is completed 1 to 4 days before the first dost of iPD1 CD19 eCAR T cells.
Timeline
- Start
- 2017-06-21
- Primary completion
- 2019-06-01
- Completion
- 2020-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | iPD1 CD19 eCAR T cells | Cell therapy | 100000 cells/kg | — |
| Subject | iPD1 CD19 eCAR T cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | iPD1 CD19 eCAR T cells | Cell therapy | 3e+06 cells/kg | — |
| Subject | iPD1 CD19 eCAR T cells | Cell therapy | 6e+06 cells/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 250 mg/m2 | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | — |