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

Available (expanded access)

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT05346835

Run by

Janssen Scientific Affairs, LLC

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Cancer Treatment Center of America Phoenix — Goodyear, Arizona, United States
• HonorHealth Cancer Transplant Institute — Scottsdale, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States
• The University of Arkansas for Medical Sciences Myeloma Institute for Research and Therapy — Little Rock, Arkansas, United States
• Alta Bates Medical Center Cancer Center — Berkeley, California, United States
• City of Hope — Duarte, California, United States
• University of California at San Diego — La Jolla, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Samuel Oschin Comprehensive Cancer Center Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California, Los Angeles UCLA — Los Angeles, California, United States
• Hoag Memorial Hospital — Newport Beach, California, United States
• Sutter Medical Foundation — Sacramento, California, United States
• University of Calif Davis Medical Center — Sacramento, California, United States
• UCSF — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center — Aurora, Colorado, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Christiana Care — Newark, Delaware, United States
• MedStar Georgetown Hospital — Washington D.C., District of Columbia, United States
• University of Florida at Shands — Gainesville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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