drugset / Trial / NCT02706405

JCAR014 and Durvalumab in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

NCT02706405 ↗

Non-randomizedSequentialOpen-labelTreatment

Summary

This phase Ib trial studies whether anti-CD19-chimeric antigen receptor (CAR) lentiviral vector-transduced autologous T cells (JCAR014) and durvalumab are safe in combination and can work together in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). JCAR014 is made of each patient's immune cells (T cells) that have a new gene added to them in a laboratory, which programs them to kill lymphoma cells. Durvalumab is a type of drug called a monoclonal antibody, targeted to PD-L1 that may help immune cells attack cancer cells more effectively and thus help JCAR014 work better.

Timeline

Start
2016-11-15
Primary completion
2021-05-28
Completion
2021-05-28

Outcome

Outcome not reported

Stopped (Enrollment): “Terminated due to slow accrual.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 7.5 mg Intravenous
Subject Durvalumab Monoclonal antibody 22.5 mg Intravenous
Subject Durvalumab Monoclonal antibody 75 mg Intravenous
Subject Durvalumab Monoclonal antibody 225 mg Intravenous
Subject Durvalumab Monoclonal antibody 750 mg Intravenous
Subject JCAR014 Cell therapy 2e+06 cells/kg Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous