Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
NCT ID: NCT05346835
Last Updated: 2026-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Cilta-cel OOS Therapy
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) will be provided as a one-time administration as an intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
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 Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
Miami, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Orlando Health
Orlando, Florida, United States
Memorial Healthcare System
Pembroke Pines, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
H Lee Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northside Hospital Cancer Institute
Atlanta, Georgia, United States
City of Hope Cancer Center
Newnan, Georgia, United States
Kapi Olani Medical Center for Women and Children Hawaii Pacific
Honolulu, Hawaii, United States
St. Luke's Mountain State Tumor Institute
Boise, Idaho, United States
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University Of Illinois
Chicago, Illinois, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
NorthShore University Health System, Evanston Hospital
Evanston, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
City of Hope Chicago
Zion, Illinois, United States
IU Health University Hospital
Indianapolis, Indiana, United States
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States
Community Health Network MD Anderson Cancer Center
Kokomo, Indiana, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Kansas Cancer Center
Fairway, Kansas, United States
Ascension via Christi Research
Wichita, Kansas, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine JHUSOM
Baltimore, Maryland, United States
Tufts New England Medical Center
Boston, Massachusetts, United States
Massachusetts General
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Brigham and Women's Cancer Center
Weymouth, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Corewell Health Grand Rapids Hospitals Butterworth
Grand Rapids, Michigan, United States
William Beaumont Health System
Royal Oak, Michigan, United States
M Health Fairview University of Minnesota Medical Center East Bank
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Ellis Fischel Cancer Center
Columbia, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ)
New Brunswick, New Jersey, United States
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
The Feinstein Institute for Medical Research (Northwell Health Inc.)
Manhasset, New York, United States
New York University Langone Medical Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Atrium Health
Charlotte, North Carolina, United States
Novant Health
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Sanford Health
Fargo, North Dakota, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
The Jewish Hospital - Mercy
Cincinnati, Ohio, United States
University Hospital of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, United States
OhioHealth Mansfield Hospital
Columbus, Ohio, United States
University of Oklahoma Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
Oregon Health And Science University
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania, United States
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Roger Williams Medical Center
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Avera McKennan Hospital
Sioux Falls, South Dakota, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Sarah Cannon Cancer Institute
Nashville, Tennessee, United States
Tennessee Valley Healthcare System
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Texas Oncology-Medical City Dallas
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
San Antonio Methodist TX Transplant Physicians Group
San Antonio, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Schar Cancer Institute Dept of Fairfax Hospital
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
VCU Medical Center
Richmond, Virginia, United States
Swedish Cancer Institute First Hill
Seattle, Washington, United States
University of Washington School of Medicine
Seattle, Washington, United States
West Virginia University Medical Center
Morgantown, West Virginia, United States
University Of Wisconsin Hospital
Madison, Wisconsin, United States
Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States
DUMMY
Dummy, , Germany
Countries
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Central Contacts
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Other Identifiers
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68284528MMY4006
Identifier Type: OTHER
Identifier Source: secondary_id
CR108968
Identifier Type: -
Identifier Source: org_study_id
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