A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

NCT05201781 | Recruiting Phase 4 FDA Drug

• 4 other identifiers: CR10912368284528MMY40022020-005521-842023-505530-10-00
• Study Type: interventional
• Target: 295
• Locations: 8 countries
• Sites: 50

Brief Summary

The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (9)

• Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy

  Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.

  Up to 15 years

• Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder

  Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.

  Up to 15 years

• Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder

  Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported.

  Up to 15 years

• Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia

  Number of participants with new incidence of Grade \>=3 hematologic disorder including hypogammaglobulinemia will be reported.

  From year 1 up to year 5

• Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia

  Number of participants with serious hematologic disorder, including hypogammaglobulinemia will be reported. Serious hematologic disorder, includes hypogammaglobulinemia (all grades, regardless of causality).

  From year 6 up to year 15

• Number of Participants with New Incidence of Grade >= 3 Infection

  Number of participants with new incidence of Grade \>=3 infection will be reported.

  From year 1 up to year 5

• Number of Participants with Serious Infection

  Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality.

  From year 6 up to year 15

• Number of Participants with Serious Adverse Events (SAEs)

  A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

  From year 1 up to year 5

• Number of Participants with Related Serious Adverse Events Assessed by the Investigator

  Number of participants with related serious adverse events assessed by the investigator will be reported. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

  From year 6 up to year 15

Secondary Outcomes (5)

• Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood

  Up to 15 years

• Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells

  Up to 15 years

• Pattern of Lentiviral Vector Integration Sites

  Up to 15 years

• Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments

  Up to 15 years

• Overall Survival (OS)

  Up to 15 years

Study Arms (1)

Cilta-cel

EXPERIMENTAL

Participants who had previously received treatment with cilta-cel in a Company-sponsored clinical study (example, NCT04923893, NCT03758417, NCT04181827, NCT05347485, NCT04133636, and NCT03548207) in the global development program will be enrolled into this study once the individual's participation in the particular interventional study has ended or a study has been terminated. Participants will not receive any treatment in this study and will be followed-up at least once per year on delayed adverse events for up to 15 years after receiving the last dose of cilta-cel.

Drug: Cilta-cel

Interventions

Cilta-cel DRUG

Participants who had received cilta-cel in previous studies will be followed up in this study. No additional study treatment will be administered to participants in this study.

Also known as: JNJ-68284528, LCAR-B38M CAR-T cells

Cilta-cel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
• Participants who have provided informed consent for this study

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (50)

Mayo Clinic Cancer Center-Scottsdale

Phoenix, Arizona, 85054, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Stanford University Medical Center

Stanford, California, 94305-5623, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Kansas University Medical Center

Westwood, Kansas, 66205, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

RECRUITING

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55902, United States

RECRUITING

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Mount Sinai Medical Center

New York, New York, 10029, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Froedtert Memorial

Milwaukee, Wisconsin, 53226, United States

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Peking University Third Hospital

Beijing, 100191, China

ACTIVE NOT RECRUITING

West China Hospital Si Chuan University

Chengdu, 610041, China

ACTIVE NOT RECRUITING

Fujian Medical University Union Hospital

Fuzhou, 350000, China

ACTIVE NOT RECRUITING

Sun Yat-sen University Cancer Hospital

Guangzhou, 510060, China

ACTIVE NOT RECRUITING

First Hospital, Zhejiang University Medical College

Hangzhou, 310003, China

ACTIVE NOT RECRUITING

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, 210008, China

ACTIVE NOT RECRUITING

Jiangsu Province Hospital

Nanjing, 210029, China

ACTIVE NOT RECRUITING

Shanghai Changzheng Hospital

Shanghai, 200003, China

ACTIVE NOT RECRUITING

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, 200025, China

ACTIVE NOT RECRUITING

Shanghai Fourth People s Hospital

Shanghai, 200434, China

ACTIVE NOT RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004, China

ACTIVE NOT RECRUITING

CHRU de Lille Hopital Claude Huriez

Nord, 59037, France

RECRUITING

Hopital Saint Louis

Paris, 75010, France

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Nagoya City University Hospital

Nagoya, 467 8602, Japan

ACTIVE NOT RECRUITING

Japanese Red Cross Medical Center

Shibuya City, 150-8935, Japan

ACTIVE NOT RECRUITING

VU Medisch Centrum

Amsterdam, 1081 HV, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Clinica Univ. de Navarra

Pamplona, 31008, Spain

RECRUITING

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 21, 2022
• Study Start: March 9, 2022
• Primary Completion (Estimated): July 29, 2037
• Study Completion (Estimated): January 26, 2038
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (11); BE (2); JP (2); US (28); ES (2); FR (2); IL (1); NL (2)