Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
NCT05346835 · Status: AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2026-02-13
Summary
The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested.
Conditions
Interventions
- DRUG
-
Cilta-cel OOS Therapy
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) will be provided as a one-time administration as an intravenous infusion.
Sponsors & Collaborators
-
Janssen Scientific Affairs, LLC
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
- Germany
Study Locations
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