A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma

Study Purpose

The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Eligible for treatment with cilta-cel per United States prescribing information (USPI) or locally approved label.
  • - Participant is suffering from serious or life threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re-manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator.
  • - Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (OOS) - Meets the criteria to receive lymphodepleting chemotherapy.
  • - 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.

Exclusion Criteria:

  • - History of active uncontrolled infection or condition where an administration of cilta-cel OOS constitutes serious health risk to the participant.
  • - Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI.
  • - Hepatitis B infection.
  • - Hepatitis C infection defined as (anti hepatitis C virus [HCV] antibody positive or detectable HCV ribonucleic acid [RNA]) or known to have a history of hepatitis C.
- Seropositive for human immunodeficiency virus (HIV) - Uncontrolled autoimmune disease

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05347485
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Scientific Affairs, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Scientific Affairs, LLC Clinical Trial
Principal Investigator Affiliation Janssen Scientific Affairs, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

Experimental: Ciltacabtagene Autoleucel (Cilta-cel)

Eligible participants will receive bridging therapy (that is, anti-plasma cell directed treatment) based on participant's clinical status and timing of availability of cilta-cel (JNJ-68284528) along with lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square [mg/m^2] intravenous [IV] and fludarabine 30 mg/m^2 IV daily, for 3 days). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants will receive a single IV infusion of cilta-cel (JNJ-68284528) at a total targeted dose of 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg).

Interventions

Drug: - Cilta-cel

Cilta-cel will be administered as an IV infusion.

Drug: - Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)

Lymphodepleting therapy (cyclophosphamide and fludarabine) will be administered intravenously.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope, Duarte, California

Status

Recruiting

Address

City of Hope

Duarte, California, 91010

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94143

Stanford University Medical Center, Stanford, California

Status

Recruiting

Address

Stanford University Medical Center

Stanford, California, 94305

Colorado Blood Cancer Institute, Denver, Colorado

Status

Recruiting

Address

Colorado Blood Cancer Institute

Denver, Colorado, 80218

Mayo Clinic, Jacksonville, Florida

Status

Withdrawn

Address

Mayo Clinic

Jacksonville, Florida, 32224

University of Miami, Miami, Florida

Status

Not yet recruiting

Address

University of Miami

Miami, Florida, 33136

Tampa, Florida

Status

Not yet recruiting

Address

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30322

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Kansas University Medical Center, Westwood, Kansas

Status

Recruiting

Address

Kansas University Medical Center

Westwood, Kansas, 66205

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Not yet recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan

Status

Recruiting

Address

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201

Mayo Clinic - Rochester, Rochester, Minnesota

Status

Not yet recruiting

Address

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Hackensack University Medical Center, Hackensack, New Jersey

Status

Recruiting

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Mount Sinai Medical Center, New York, New York

Status

Recruiting

Address

Mount Sinai Medical Center

New York, New York, 10029

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Levine Cancer Institute, Charlotte, North Carolina

Status

Recruiting

Address

Levine Cancer Institute

Charlotte, North Carolina, 28204

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Seattle, Washington

Status

Not yet recruiting

Address

University of Washington-Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109

Medical College Of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226