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NCT04231747 · ClinicalTrials.gov registry record · Phase 1
A Study of CC-97540, CD19-targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
A Phase 1 study, sponsored by Juno Therapeutics, a Subsidiary of Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04231747: Completed Phase 1 study, sponsored by Juno Therapeutics, a Subsidiary of Celgene.
NCT04231747 is a Phase 1 study that has completed, run by Juno Therapeutics, a Subsidiary of Celgene. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04231747, a Phase 1 study, has completed, sponsored by Juno Therapeutics, a Subsidiary of Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a Phase 1, first-in-human, open-label, multicenter study of CC-97540, CD19-targeted NEX-T chimeric antigen receptor (CAR) T cells, in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma. The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-97540 to establish a recommended Phase 2 dose (RP2D); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-97540 at the RP2D.
Primary Outcome
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.ject's health, including
Interventions
- BIOLOGICAL CC-97540
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-05-21 |
| Est. Completion | 2024-02-01 |
| Phase | Phase 1 |
What the finished NCT04231747 record still lists
NCT04231747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which CC-97540 is the first listed.
NCT04231747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04231747 about?
NCT04231747 is a clinical study titled "A Study of CC-97540, CD19-targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma". This is a Phase 1, first-in-human, open-label, multicenter study of CC-97540, CD19-targeted NEX-T chimeric antigen receptor (CAR) T cells, in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma. The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). Th...
What is the current status of trial NCT04231747?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-05-21. Estimated completion is 2024-02-01.
What interventions are being tested in trial NCT04231747?
The interventions under investigation include: CC-97540 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04231747?
This trial is sponsored by Juno Therapeutics, a Subsidiary of Celgene, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04231747's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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