Safety and Efficacy of iPD1 CD19 eCAR T Cells in Relapsed or Refractory B-cell Lymphoma

Relapsed or Refractory B-cell Lymphoma Clinical Trial

Official title: Pilot Study of Autologous Anti-CD19 4-1BB CAR T Cells With Cell-intrinsic PD1 Inhibition in Relapsed or Refractory B-cell Lymphoma

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Relapsed or Refractory B-cell Lymphoma

• NCT number: NCT03208556
• Study type: Interventional
• Source: Peking University
• Contact: Jun Zhu, MD
• Phone: +86-10-88196596
• Email: zj@bjcancer.org
• Status: Recruiting
• Phase: Phase 1
• Start date: June 21, 2017
• Completion date: June 1, 2020