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NCT03318861 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma
A Phase 1 study, sponsored by Kite, A Gilead Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT03318861: Clinical Trial Phase 1 study, sponsored by Kite, A Gilead Company.
NCT03318861 is a Phase 1 study that was terminated before completion, run by Kite, A Gilead Company. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03318861, a Phase 1 study, was terminated before completion, sponsored by Kite, A Gilead Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the safety and tolerability of KITE-585, an autologous engineered chimeric antigen receptor (CAR) T-cell product targeting a protein commonly found on myeloma cells called B-cell maturation antigen (BCMA), as measured by the incidence of dose-limiting toxicities (DLTs). Participants will be given a 3 day course of conditioning chemotherapy followed by a single infusion of KITE-585.
Primary Outcome
A DLT is a KITE-585-related event with onset in the first 28 days following infusion. DLTs are defined by events and duration of events, including: * Any duration: Grade (GR) 4 cytokine release syndrome (CRS), KITE-585-related GR 5 adverse events (AE) and GR 4 nonhematologic AE with the exceptions of fever, nausea, hepatic toxicity that resolves to GR 3 or better in ≤ 72 hours, hypogammaglobulinemia, tumor lysis syndrome, acute renal toxicity requiring dialysis for ≤ 7 days, intubation for airw
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- GENETIC KITE-585
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-10-20 |
| Est. Completion | 2022-09-16 |
| Phase | Phase 1 |
Why NCT03318861 stopped before completion
NCT03318861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT03318861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03318861 about?
NCT03318861 is a clinical study titled "Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma". The primary objective of the study is to evaluate the safety and tolerability of KITE-585, an autologous engineered chimeric antigen receptor (CAR) T-cell product targeting a protein commonly found on myeloma cells called B-cell maturation antigen (BCMA), as measured by the incidence of dose-limitin...
What is the current status of trial NCT03318861?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2017-10-20. Estimated completion is 2022-09-16.
What interventions are being tested in trial NCT03318861?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), KITE-585 (GENETIC).
Who is sponsoring clinical trial NCT03318861?
This trial is sponsored by Kite, A Gilead Company, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03318861's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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