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NCT03743246 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)
A Phase 1 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT03743246 is a Phase 1 study that was terminated before completion, run by Celgene. The registered enrollment target is 21 participants.
The verdict
NCT03743246, a Phase 1 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a Phase 1/2, open-label, single arm, multicohort study to evaluate the safety and efficacy of JCAR017 in pediatric subjects aged ≤ 25 years with CD19+ r/r B-ALL and B-NHL. Phase 1 will identify a recommended Phase 2 dose (RP2D). Phase 2 will evaluate the efficacy of JCAR017 RP2D in the following three disease cohorts: Cohort 1 (r/r B-ALL), Cohort 2 (MRD+ B-ALL) and Cohort 3 (r/r B-NHL, \[DLBCL, BL, or PMBCL\]). A Simon's Optimal two-stage study design will be applied to Cohort 1 and 2 in Phase 2.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG JCAR017
- DRUG Lymphodepleting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-10-17 |
| Est. Completion | 2024-01-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03743246
The ClinicalTrials.gov registry entry for NCT03743246 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 21 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 4 interventions - of which Cyclophosphamide is the first listed.
NCT03743246 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03743246 about?
NCT03743246 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)". This is a Phase 1/2, open-label, single arm, multicohort study to evaluate the safety and efficacy of JCAR017 in pediatric subjects aged ≤ 25 years with CD19+ r/r B-ALL and B-NHL. Phase 1 will identify a recommended Phase 2 dose (RP2D). Phase 2 will evaluate the efficacy of JCAR017 RP2D in the foll...
What is the current status of trial NCT03743246?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2018-10-17. Estimated completion is 2024-01-26.
What interventions are being tested in trial NCT03743246?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), JCAR017 (DRUG), Lymphodepleting (DRUG).
Who is sponsoring clinical trial NCT03743246?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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