An Exploratory Phase 1/2 trial to Evaluate the Safety and Efficacy of JCAR017 Combinations in Subjects with Relapsed/Refractory B-Cell Malignancies (Platform)
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/Chronic lymphocytic leukemia (CLL)
Current Status: Open to accrual
Phase: I/II
Principal Investigator: Lunning, Matthew
Contact Information:
Susan Blumel, RN
402-559-9183
sblumel@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03310619#eligibility
Summary
This is a global, open-label, multi-arm, 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.
During the Phase 1 part, different arms may be opened to test JCAR017 in combination with combination agent(s). Within each arm, different doses and schedules of JCAR017 and the combination agent(s) may be tested in several cohorts and subcohorts per arm. During the Phase 2 part of the study, the expansion of any dose level and schedule that has been shown to be safe may occur. The following combinations will be tested in adult subjects with R/R aggressive B-cell NHL:
Arm A: JCAR017 in combination with durvalumab
Arm B: JCAR017 in combination with avadomide (CC-122)
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
All subjects from Phase 1 and Phase 2 will be followed for 24 months following JCAR017 infusion. Post-study follow-up for survival, relapse, long-term toxicity, and viral vector safety will continue under a separate long-term follow-up protocol for up to 15 years after the JCAR017 dose as per health authority regulatory guidelines.