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

ClinicalTrials.gov ID: NCT05346835

Public ClinicalTrials.gov record NCT05346835. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05346835
Recruitment status
Available
Study type
Expanded access
Phase
Not listed
Lead sponsor
Janssen Scientific Affairs, LLC
Industry
Enrollment
Not listed

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Not listed
Last update posted
Feb 12, 2026

United States locations

U.S. sites
137
U.S. states
45
U.S. cities
99
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 Available
Banner MD Anderson Cancer Center Gilbert Arizona 85234 Available
Cancer Treatment Center of America Phoenix Goodyear Arizona 85338 Available
HonorHealth Cancer Transplant Institute Scottsdale Arizona 85258 Available
Mayo Clinic Scottsdale Arizona 85259 Available
University of Arizona Cancer Center Tucson Arizona 85719 Available
The University of Arkansas for Medical Sciences Myeloma Institute for Research and Therapy Little Rock Arkansas 72205 Available
Alta Bates Medical Center Cancer Center Berkeley California 94704 Available
City of Hope Duarte California 91010 Available
University of California at San Diego La Jolla California 92093 Available
USC Norris Comprehensive Cancer Center Los Angeles California 90033 Available
Samuel Oschin Comprehensive Cancer Center Cedars-Sinai Medical Center Los Angeles California 90048 Available
University of California, Los Angeles UCLA Los Angeles California 90095 Available
Hoag Memorial Hospital Newport Beach California 92658 Available
Sutter Medical Foundation Sacramento California 95816 Available
University of Calif Davis Medical Center Sacramento California 95817 Available
UCSF San Francisco California 94143 Available
Stanford University Medical Center Stanford California 94305 Available
UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center Aurora Colorado 80045 Available
Colorado Blood Cancer Institute Denver Colorado 80218 Available
Yale New Haven Hospital New Haven Connecticut 06520 Available
Christiana Care Newark Delaware 19713 Available
MedStar Georgetown Hospital Washington D.C. District of Columbia 20007 Available
University of Florida at Shands Gainesville Florida 32611 Available
Mayo Clinic Jacksonville Florida 32224 Available
University of Miami Sylvester Comprehensive Cancer Center Miami Florida 33136 Available
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group Miami Florida 33176 Available
Advent Health Orlando Orlando Florida 32803 Available
Orlando Health Orlando Florida 32806 Available
Memorial Healthcare System Pembroke Pines Florida 33028 Available
Tampa General Hospital Tampa Florida 33606 Available
H Lee Moffitt Cancer Center Tampa Florida 33612 Available
Emory University Atlanta Georgia 30322 Available
Northside Hospital Cancer Institute Atlanta Georgia 30342 Available
City of Hope Cancer Center Newnan Georgia 30265 Available
Kapi Olani Medical Center for Women and Children Hawaii Pacific Honolulu Hawaii 96826 Available
St. Luke's Mountain State Tumor Institute Boise Idaho 83712 Available
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion Chicago Illinois 60611 Available
Rush University Medical Center Chicago Illinois 60612 Available
University Of Illinois Chicago Illinois 60612 Available
The University of Chicago Medical Center (UCMC) Chicago Illinois 60637 Available
NorthShore University Health System, Evanston Hospital Evanston Illinois 60201 Available
Loyola University Medical Center Maywood Illinois 60153 Available
Advocate Lutheran General Hospital Park Ridge Illinois 60068 Available
City of Hope Chicago Zion Illinois 60099 Available
IU Health University Hospital Indianapolis Indiana 46202 Available
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Indianapolis Indiana 46237 8601 Available
Community Health Network MD Anderson Cancer Center Kokomo Indiana 46902 Available
University of Iowa Hospital and Clinics Iowa City Iowa 52242 Available
University of Kansas Cancer Center Fairway Kansas 66205 Available
Ascension via Christi Research Wichita Kansas 67214 Available
University of Kentucky Chandler Medical Center Lexington Kentucky 40508 Available
University of Louisville - James Graham Brown Cancer Center Louisville Kentucky 40202 Available
Norton Cancer Institute Louisville Kentucky 40207 Available
Ochsner Clinic Foundation New Orleans Louisiana 70121 Available
University of Maryland School of Medicine Baltimore Maryland 21201 Available
Johns Hopkins University School of Medicine JHUSOM Baltimore Maryland 21205 Available
Tufts New England Medical Center Boston Massachusetts 02111 Available
Massachusetts General Boston Massachusetts 02114 Available
Boston University Medical Center Boston Massachusetts 02118 Available
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 Available
Dana-Farber Brigham and Women's Cancer Center Weymouth Massachusetts 02190 Available
University of Massachusetts Medical School Worcester Massachusetts 01655 Available
University of Michigan Rogel Cancer Center Ann Arbor Michigan 48109 Available
Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center Farmington Hills Michigan 48334 Available
Corewell Health Grand Rapids Hospitals Butterworth Grand Rapids Michigan 49503 Available
William Beaumont Health System Royal Oak Michigan 48073 Available
M Health Fairview University of Minnesota Medical Center East Bank Minneapolis Minnesota 55455 Available
Mayo Clinic Rochester Rochester Minnesota 55905 Available
University of Mississippi Medical Center Jackson Mississippi 39213 Available
Ellis Fischel Cancer Center Columbia Missouri 65201 Available
Saint Louis University St Louis Missouri 63110 Available
Washington University School Of Medicine St Louis Missouri 63110 Available
University of Nebraska Medical Center Omaha Nebraska 68198 Available
Dartmouth Hitchcock Medical Center Lebanon New Hampshire 03756 Available
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey 07601 Available
Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ) New Brunswick New Jersey 08901-1914 Available
University of New Mexico School of Medicine Albuquerque New Mexico 87106 Available
Roswell Park Comprehensive Cancer Center Buffalo New York 14203 Available
The Feinstein Institute for Medical Research (Northwell Health Inc.) Manhasset New York 11030 Available
New York University Langone Medical Center New York New York 10010 Available
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg New York New York 10029 Available
Columbia University Medical Center New York New York 10032 Available
Memorial Sloan Kettering Cancer Center New York New York 10065 Available
Weill Cornell Medical Center New York New York 10065 Available
University of Rochester Medical Center Rochester New York 14642 Available
Montefiore Medical Center The Bronx New York 10467 Available
University of North Carolina Hospital Chapel Hill North Carolina 27514 Available
Atrium Health Charlotte North Carolina 28204 Available
Novant Health Charlotte North Carolina 28204 Available
Duke University Durham North Carolina 27710 Available
Novant Health Forsyth Medical Center Winston-Salem North Carolina 27103 Available
Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem North Carolina 27157 Available
Sanford Health Fargo North Dakota 58122 Available
Good Samaritan Hospital Cincinnati Ohio 45220 Available
The Jewish Hospital - Mercy Cincinnati Ohio 45236 Available
University Hospital of Cleveland Cleveland Ohio 44106 Available
Cleveland Clinic Cleveland Ohio 44145 Available
The Ohio State University Wexner Medical Center - James Cancer Hospital Columbus Ohio 43210 Available
OhioHealth Mansfield Hospital Columbus Ohio 43214 Available
University of Oklahoma Stephenson Cancer Center Oklahoma City Oklahoma 73104 Available
Providence Portland Medical Center Portland Oregon 97213 Available
Oregon Health And Science University Portland Oregon 97239 Available
Geisinger Medical Center Danville Pennsylvania 17622 Available
Penn State Milton S Hershey Medical Ctr Hershey Pennsylvania 17033 Available
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine Philadelphia Pennsylvania 19104 Available
Thomas Jefferson University Philadelphia Pennsylvania 19107 Available
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 Available
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15323 Available
Roger Williams Medical Center Providence Rhode Island 02908 Available
Medical University of South Carolina Charleston South Carolina 29425 Available
Prisma Health Greenville South Carolina 29615 Available
Avera McKennan Hospital Sioux Falls South Dakota 57105 Available
University of Tennessee Medical Center Knoxville Tennessee 37920 Available
Baptist Clinical Research Institute Memphis Tennessee 38120 Available
Sarah Cannon Cancer Institute Nashville Tennessee 37203 Available
Tennessee Valley Healthcare System Nashville Tennessee 37212 Available
Vanderbilt University Medical Center Nashville Tennessee 37232 Available
St. David's South Austin Medical Center Austin Texas 78704 Available
Texas Oncology-Medical City Dallas Dallas Texas 75230 Available
Baylor University Medical Center Dallas Texas 75246 Available
UT Southwestern Medical Center Dallas Texas 75390 Available
Houston Methodist Hospital Houston Texas 77030 Available
MD Anderson Cancer Center Houston Texas 77030 Available
San Antonio Methodist TX Transplant Physicians Group San Antonio Texas 78229 Available
Huntsman Cancer Institute Salt Lake City Utah 84112 Available
Intermountain Healthcare Salt Lake City Utah 84143 Available
University of Virginia Charlottesville Virginia 22903 Available
Inova Schar Cancer Institute Dept of Fairfax Hospital Fairfax Virginia 22031 Available
Virginia Oncology Associates Norfolk Virginia 23502 Available
VCU Medical Center Richmond Virginia 23219 Available
Swedish Cancer Institute First Hill Seattle Washington 98104 Available
University of Washington School of Medicine Seattle Washington 98195 Available
West Virginia University Medical Center Morgantown West Virginia 26506 Available
University Of Wisconsin Hospital Madison Wisconsin 53792 Available
Aurora Saint Lukes Medical Center Milwaukee Wisconsin 53215 Available
Medical College Of Wisconsin Milwaukee Wisconsin 53226 Available

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05346835, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 12, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05346835 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →