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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT02706405
Phase
PHASE1
Status
Terminated

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing CD4+/CD8+ Central Memory T-lymphocytes JCAR014 — BIOLOGICAL
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Durvalumab — BIOLOGICAL
    Given IV
  • Fludarabine — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Nov 15, 2016
Status verified
Aug 2022
Primary completion
May 28, 2021
Completion
May 28, 2021

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I (JCAR014, durvalumab) Early - Dose Level 2
    Patients receive JCAR014 IV over 20-30 minutes on day 0 and durvalumab IV over 60 minutes on day 21 (may occur as early as day 7) and then every 4 weeks for up to 10 doses in the absence of disease progression or unacceptable toxicity. Group 1 - early: start durvalumab no earlier than 7 days after JCAR014. Group 1 Dose Level 2 is 750 mg Durvalumab, up to 2 x 106/kg CAR T cells
  • Experimental: Group I (JCAR014, durvalumab) Late- Dose Level 1
    Patients receive JCAR014 IV over 20-30 minutes on day 0 and durvalumab IV over 60 minutes on day 21 (may occur as early as day 7) and then every 4 weeks for up to 10 doses in the absence of disease progression or unacceptable toxicity. Group 1 - late: start durvalumab no earlier than 21 days after JCAR014 Group 1 Dose Level 1 is 225 mg Durvalumab, up to 2 x 106/kg CAR T cells .
  • Experimental: Group I (JCAR014, durvalumab) Late - Dose Level 2
    Patients receive JCAR014 IV over 20-30 minutes on day 0 and durvalumab IV over 60 minutes on day 21 (may occur as early as day 7) and then every 4 weeks for up to 10 doses in the absence of disease progression or unacceptable toxicity. Group 1 - late: start durvalumab no earlier than 21 days after JCAR014 Group 1 Dose Level 2 is 750 mg Durvalumab, up to 2 x 106/kg CAR T cells
  • Experimental: Group II (durvalumab, JCAR014) - Dose Level 1
    Patients receive durvalumab IV over 60 minutes on day -1, JCAR014 IV over 20-30 minutes on day 0, then up to 10 additional doses of durvalumab every 4 weeks in the absence of disease progression or unacceptable toxicity. Group 2 Dose Level 1 is 7.5 mg Durvalumab, up to 2 x 106/kg CAR T cells
  • Experimental: Group II (durvalumab, JCAR014) - Dose Level 2
    Patients receive durvalumab IV over 60 minutes on day -1, JCAR014 IV over 20-30 minutes on day 0, then up to 10 additional doses of durvalumab every 4 weeks in the absence of disease progression or unacceptable toxicity. Group 2 Dose Level 2 is 22.5 mg Durvalumab, up to 2 x 106/kg CAR T cells
  • Experimental: Group II (durvalumab, JCAR014) - Dose Level 3
    Patients receive durvalumab IV over 60 minutes on day -1, JCAR014 IV over 20-30 minutes on day 0, then up to 10 additional doses of durvalumab every 4 weeks in the absence of disease progression or unacceptable toxicity. Group 2 Dose Level 3 is 75 mg Durvalumab, up to 2 x 106/kg CAR T cells
  • Experimental: Group II (durvalumab, JCAR014) - Dose Level 4
    Patients receive durvalumab IV over 60 minutes on day -1, JCAR014 IV over 20-30 minutes on day 0, then up to 10 additional doses of durvalumab every 4 weeks in the absence of disease progression or unacceptable toxicity. Group 2 Dose Level 4 is 225 mg Durvalumab, up to 2 x 106/kg CAR T cells
  • Experimental: Group II (durvalumab, JCAR014) - Dose Level 5
    Patients receive durvalumab IV over 60 minutes on day -1, JCAR014 IV over 20-30 minutes on day 0, then up to 10 additional doses of durvalumab every 4 weeks in the absence of disease progression or unacceptable toxicity. Group 2 Dose Level 5 is 750 mg Durvalumab, up to 2 x 106/kg CAR T cells

Primary Outcome Measure

Count of Participants Who Experienced Adverse Events [ Time Frame: 28 days post last infusion of Durvalumab, up to 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

Related Studies