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NCT03548207 · ClinicalTrials.gov registry record · Phase 1
A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 126
- Enrollment target
NCT03548207: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT03548207 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 126 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (110% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03548207, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 126 participants
- Enrollment target
Study Summary
The purpose of the study is to characterize safety of JNJ-68284528 and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of JNJ-68284528 (Phase 2).
Primary Outcome
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threate
Interventions
- BIOLOGICAL JNJ-68284528
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2018-06-29 |
| Est. Completion | 2022-08-23 |
| Phase | Phase 1 |
What the finished NCT03548207 record still lists
NCT03548207 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (110% higher).
The record links to 0 conditions, and to 1 intervention - of which JNJ-68284528 is the first listed.
NCT03548207 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03548207 about?
NCT03548207 is a clinical study titled "A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma". The purpose of the study is to characterize safety of JNJ-68284528 and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of JNJ-68284528 (Phase 2).
What is the current status of trial NCT03548207?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 126 participants. The study started on 2018-06-29. Estimated completion is 2022-08-23.
What interventions are being tested in trial NCT03548207?
The interventions under investigation include: JNJ-68284528 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03548207?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03548207's enrollment target sits among peer trials
126 461st of 2000 higher than 1,534 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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