CClinicalTrials.gg
AvailableNCT05346835Updated Feb 13, 2026

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

An expanded access record providing Cilta-cel OOS Therapy in Multiple Myeloma, sponsored by Janssen Scientific Affairs, LLC. Available at 138 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by Janssen Scientific Affairs, LLC · Expanded access

Study type
Expanded access
Access type
Intermediate-size population
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Myeloma

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Eligibility criteria

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
04

Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

  • DrugCilta-cel OOS Therapy

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

    Also known as: JNJ-68284528

05

Where to request access

138 of 138 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
    Available
  • Banner MD Anderson Cancer Center
    Gilbert, Arizona 85234, United States
    Available
  • Cancer Treatment Center of America Phoenix
    Goodyear, Arizona 85338, United States
    Available
  • HonorHealth Cancer Transplant Institute
    Scottsdale, Arizona 85258, United States
    Available
  • Mayo Clinic
    Scottsdale, Arizona 85259, United States
    Available
  • University of Arizona Cancer Center
    Tucson, Arizona 85719, United States
    Available
  • The University of Arkansas for Medical Sciences Myeloma Institute for Research and Therapy
    Little Rock, Arkansas 72205, United States
    Available
  • Alta Bates Medical Center Cancer Center
    Berkeley, California 94704, United States
    Available
  • City of Hope
    Duarte, California 91010, United States
    Available
  • University of California at San Diego
    La Jolla, California 92093, United States
    Available
  • USC Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
    Available
  • Samuel Oschin Comprehensive Cancer Center Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
    Available
  • University of California, Los Angeles UCLA
    Los Angeles, California 90095, United States
    Available
  • Hoag Memorial Hospital
    Newport Beach, California 92658, United States
    Available
  • Sutter Medical Foundation
    Sacramento, California 95816, United States
    Available
  • University of Calif Davis Medical Center
    Sacramento, California 95817, United States
    Available
  • UCSF
    San Francisco, California 94143, United States
    Available
  • Stanford University Medical Center
    Stanford, California 94305, United States
    Available
  • UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center
    Aurora, Colorado 80045, United States
    Available
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
    Available
  • Yale New Haven Hospital
    New Haven, Connecticut 06520, United States
    Available
  • Christiana Care
    Newark, Delaware 19713, United States
    Available
  • MedStar Georgetown Hospital
    Washington D.C., District of Columbia 20007, United States
    Available
  • University of Florida at Shands
    Gainesville, Florida 32611, United States
    Available
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
    Available
  • University of Miami Sylvester Comprehensive Cancer Center
    Miami, Florida 33136, United States
    Available
  • Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
    Miami, Florida 33176, United States
    Available
  • Advent Health Orlando
    Orlando, Florida 32803, United States
    Available
  • Orlando Health
    Orlando, Florida 32806, United States
    Available
  • Memorial Healthcare System
    Pembroke Pines, Florida 33028, United States
    Available
  • Tampa General Hospital
    Tampa, Florida 33606, United States
    Available
  • H Lee Moffitt Cancer Center
    Tampa, Florida 33612, United States
    Available
  • Emory University
    Atlanta, Georgia 30322, United States
    Available
  • Northside Hospital Cancer Institute
    Atlanta, Georgia 30342, United States
    Available
  • City of Hope Cancer Center
    Newnan, Georgia 30265, United States
    Available
  • Kapi Olani Medical Center for Women and Children Hawaii Pacific
    Honolulu, Hawaii 96826, United States
    Available
  • St. Luke's Mountain State Tumor Institute
    Boise, Idaho 83712, United States
    Available
  • Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
    Chicago, Illinois 60611, United States
    Available
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
    Available
  • University Of Illinois
    Chicago, Illinois 60612, United States
    Available
  • The University of Chicago Medical Center (UCMC)
    Chicago, Illinois 60637, United States
    Available
  • NorthShore University Health System, Evanston Hospital
    Evanston, Illinois 60201, United States
    Available
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
    Available
  • Advocate Lutheran General Hospital
    Park Ridge, Illinois 60068, United States
    Available
  • City of Hope Chicago
    Zion, Illinois 60099, United States
    Available
  • IU Health University Hospital
    Indianapolis, Indiana 46202, United States
    Available
  • St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
    Indianapolis, Indiana 46237 8601, United States
    Available
  • Community Health Network MD Anderson Cancer Center
    Kokomo, Indiana 46902, United States
    Available
  • University of Iowa Hospital and Clinics
    Iowa City, Iowa 52242, United States
    Available
  • University of Kansas Cancer Center
    Fairway, Kansas 66205, United States
    Available
  • Ascension via Christi Research
    Wichita, Kansas 67214, United States
    Available
  • University of Kentucky Chandler Medical Center
    Lexington, Kentucky 40508, United States
    Available
  • University of Louisville - James Graham Brown Cancer Center
    Louisville, Kentucky 40202, United States
    Available
  • Norton Cancer Institute
    Louisville, Kentucky 40207, United States
    Available
  • Ochsner Clinic Foundation
    New Orleans, Louisiana 70121, United States
    Available
  • University of Maryland School of Medicine
    Baltimore, Maryland 21201, United States
    Available
  • Johns Hopkins University School of Medicine JHUSOM
    Baltimore, Maryland 21205, United States
    Available
  • Tufts New England Medical Center
    Boston, Massachusetts 02111, United States
    Available
  • Massachusetts General
    Boston, Massachusetts 02114, United States
    Available
  • Boston University Medical Center
    Boston, Massachusetts 02118, United States
    Available
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
    Available
  • Dana-Farber Brigham and Women's Cancer Center
    Weymouth, Massachusetts 02190, United States
    Available
  • University of Massachusetts Medical School
    Worcester, Massachusetts 01655, United States
    Available
  • University of Michigan Rogel Cancer Center
    Ann Arbor, Michigan 48109, United States
    Available
  • Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center
    Farmington Hills, Michigan 48334, United States
    Available
  • Corewell Health Grand Rapids Hospitals Butterworth
    Grand Rapids, Michigan 49503, United States
    Available
  • William Beaumont Health System
    Royal Oak, Michigan 48073, United States
    Available
  • M Health Fairview University of Minnesota Medical Center East Bank
    Minneapolis, Minnesota 55455, United States
    Available
  • Mayo Clinic Rochester
    Rochester, Minnesota 55905, United States
    Available
  • University of Mississippi Medical Center
    Jackson, Mississippi 39213, United States
    Available
  • Ellis Fischel Cancer Center
    Columbia, Missouri 65201, United States
    Available
  • Saint Louis University
    St Louis, Missouri 63110, United States
    Available
  • Washington University School Of Medicine
    St Louis, Missouri 63110, United States
    Available
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
    Available
  • Dartmouth Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
    Available
  • John Theurer Cancer Center at Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
    Available
  • Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ)
    New Brunswick, New Jersey 08901-1914, United States
    Available
  • University of New Mexico School of Medicine
    Albuquerque, New Mexico 87106, United States
    Available
  • Roswell Park Comprehensive Cancer Center
    Buffalo, New York 14203, United States
    Available
  • The Feinstein Institute for Medical Research (Northwell Health Inc.)
    Manhasset, New York 11030, United States
    Available
  • New York University Langone Medical Center
    New York, New York 10010, United States
    Available
  • Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
    New York, New York 10029, United States
    Available
  • Columbia University Medical Center
    New York, New York 10032, United States
    Available
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Available
  • Weill Cornell Medical Center
    New York, New York 10065, United States
    Available
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
    Available
  • Montefiore Medical Center
    The Bronx, New York 10467, United States
    Available
  • University of North Carolina Hospital
    Chapel Hill, North Carolina 27514, United States
    Available
  • Atrium Health
    Charlotte, North Carolina 28204, United States
    Available
  • Novant Health
    Charlotte, North Carolina 28204, United States
    Available
  • Duke University
    Durham, North Carolina 27710, United States
    Available
  • Novant Health Forsyth Medical Center
    Winston-Salem, North Carolina 27103, United States
    Available
  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157, United States
    Available
  • Sanford Health
    Fargo, North Dakota 58122, United States
    Available
  • Good Samaritan Hospital
    Cincinnati, Ohio 45220, United States
    Available
  • The Jewish Hospital - Mercy
    Cincinnati, Ohio 45236, United States
    Available
  • University Hospital of Cleveland
    Cleveland, Ohio 44106, United States
    Available
  • Cleveland Clinic
    Cleveland, Ohio 44145, United States
    Available
  • The Ohio State University Wexner Medical Center - James Cancer Hospital
    Columbus, Ohio 43210, United States
    Available
  • OhioHealth Mansfield Hospital
    Columbus, Ohio 43214, United States
    Available

Showing the first 100 of 138 sites across 2 countries.

06

Registry details

Key details

Study ID
NCT05346835
Lead sponsor
Janssen Scientific Affairs, LLC
Responsible party
Sponsor
First posted
Apr 26, 2022
Last update
Feb 13, 2026

Study contacts

Study Contact
Contact
Janssenmedinfo@its.jnj.com
1-800-526-7736
View the source record on ClinicalTrials.gov ↗

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