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Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma

Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05346835
Enrollment
Unknown
Registered
2022-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief 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.

Interventions

DRUGCilta-cel OOS Therapy

Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) will be provided as a one-time administration as an intravenous infusion.

Sponsors

Janssen Scientific Affairs, LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Eligible for treatment with cilta-cel per United States Prescribing Information (USPI) * Has serious or life-threatening multiple myeloma per USPI, and where re-apheresis, re-manufacturing, or other anti-myeloma directed therapy is not considered feasible or adequate per treating physician discretion * Favorable participant benefit/risk assessment determined by Janssen medical review * Treating physician confirms the favorable risk benefit profile, and that proceeding with this treatment is in the best interest of the participant * Able to provide informed consent indicating they understand the purpose of this expanded access program (EAP) * A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine

Countries

Germany, United States

Contacts

CONTACTStudy Contact
Janssenmedinfo@its.jnj.com1-800-526-7736

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026