MedTrace Logo

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

NCT02706405 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-08-24

Study results available
· View outcomes & findings →

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.

Conditions

  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma

Interventions

BIOLOGICAL

Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing CD4+/CD8+ Central Memory T-lymphocytes JCAR014

Given IV

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Durvalumab

Given IV

DRUG

Fludarabine

Given IV

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

    collaborator INDUSTRY

  • MedImmune LLC

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Jordan Gauthier · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-15
Primary Completion
2021-05-28
Completion
2021-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02706405 on ClinicalTrials.gov