Trials / Completed
CompletedNCT05347485
A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma
A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Janssen Scientific Affairs, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cilta-cel | Cilta-cel will be administered as an IV infusion. |
| DRUG | Lymphodepleting Therapy (Cyclophosphamide and Fludarabine) | Lymphodepleting therapy (cyclophosphamide and fludarabine) will be administered intravenously. |
Timeline
- Start date
- 2022-05-13
- Primary completion
- 2023-11-30
- Completion
- 2023-12-15
- First posted
- 2022-04-26
- Last updated
- 2025-04-25
- Results posted
- 2024-12-27
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05347485. Inclusion in this directory is not an endorsement.