drugset / Trial / NCT05347485
A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).
Timeline
- Start
- 2022-05-13
- Primary completion
- 2023-11-30
- Completion
- 2023-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ciltacabtagene autoleucel | Cell therapy | 750000 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |