A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies

Part of paid clinical trials in Duarte, California.

Sponsor
Celgene
Study ID
NCT03310619
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin

Eligibility Criteria

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

Interventions

  • JCAR017 — BIOLOGICAL
    Gene modified autologous T cells
  • Durvalumab — DRUG
    Anti-PD-L1
  • CC-122 — DRUG
    Pleiotropic Pathway Modifier
  • Ibrutinib — DRUG
    Ibrutinib
  • CC-220 — DRUG
    CC-220
  • Relatlimab — DRUG
    Relatlimab
  • Nivolumab — DRUG
    Nivolumab
  • CC-99282 — DRUG
    CC-99282

Study Details

This is a global, open-label, multi-arm, parallel multi-cohort, multi-center, Phase 1/2 study to determine the safety, tolerability, PK, efficacy and patient-reported quality of life of JCAR017 in combination with various agents. This protocol is intended to evaluate various drug combinations with JCAR017, as separate arms, over the life of the protocol, using the same objectives. Each combination will be evaluated separately (ie, the intention is not to compare between combinations) for the purposes of the objectives, trial design, and statistical analysis. The following combinations will be tested: Arm A: JCAR017 in combination with durvalumab Arm B: JCAR017 in combination with CC-122 (avadomide) Arm C: JCAR017 in combination with CC-220 (iberdomide) Arm D: JCAR017 in combination with ibrutinib Arm E: JCAR017 in combination with relatlimab and/or nivolumab Arm F: JCAR017 in combination with CC-99282 Additional arms will be added by way of amendment once combination agents have been selected. The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2). Dose expansion may occur in one or more arms.

Key Dates

Start date
Dec 20, 2017
Status verified
Mar 2024
Primary completion
Feb 15, 2023
Completion
Feb 15, 2023

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: JCAR017 in combination with Durvalumab
    JCAR017 will be administered at a single flat dose of 50 x 10\^6 CAR+T cells or 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/ or schedules
  • Experimental: Arm B: JCAR017 in combination with CC-122
    This arm will test JCAR017 in combination with the CC-122. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses
  • Experimental: Arm C: JCAR017 in combination with CC-220
    This arm will test JCAR017 in combination with CC-220. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses
  • Experimental: Arm D: JCAR017 in combination with Ibrutinib
    This arm will test JCAR017 in combination with ibrutinib. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at a fixed dose of 420 mg daily
  • Experimental: Arm E: JCAR017 in combination with relatlimab and/or nivolumab
    This arm will test JCAR017 in combination with relatlimab and/or nivolumab in adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/or schedules
  • Experimental: Arm F: JCAR017 in combination with CC-99282
    This arm will test JCAR017 in combination with CC-99282 in adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/or schedules.

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicity (DLT) [ Time Frame: From first dose of the combination agent until 1 month (28 days) after JCAR017 infusion (pre- JCAR017 cohort) or from JCAR017 infusion until 1 month (28 days) after the first dose of combination agent (post-JCAR017 cohort) ]

Locations (9)

FacilityCityStateZIPSite coordinators
Local Institution - 011DuarteCalifornia91010-
Local Institution - 022AtlantaGeorgia30342-
Local Institution - 014ChicagoIllinois60611-5975-
Local Institution - 012BostonMassachusetts02114-
Local Institution - 021BostonMassachusetts02215-
Local Institution - 015OmahaNebraska68198-7680-
Local Institution - 016PhiladelphiaPennsylvania19104-
Local Institution - 020PittsburghPennsylvania15232-
Local Institution - 013HoustonTexas77030-

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