Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03310619 · ClinicalTrials.gov registry record · Phase 1
A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT03310619 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 62 participants.
The verdict
NCT03310619, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Ibrutinib
- DRUG Durvalumab
- DRUG CC-220
- DRUG CC-122
- BIOLOGICAL JCAR017
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2017-12-20 |
| Est. Completion | 2023-02-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03310619
The ClinicalTrials.gov registry entry for NCT03310619 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ibrutinib is the first listed.
NCT03310619 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03310619 about?
NCT03310619 is a clinical study titled "A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies". 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 J...
What is the current status of trial NCT03310619?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2017-12-20. Estimated completion is 2023-02-15.
What interventions are being tested in trial NCT03310619?
The interventions under investigation include: Ibrutinib (DRUG), Durvalumab (DRUG), CC-220 (DRUG), CC-122 (DRUG), JCAR017 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03310619?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.