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

Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Cilta-cel

Detailed Description

Cilta-cel (JNJ-68284528/LCAR-B38M chimeric antigen receptor T-cells [CAR-T]) is an autologous CAR-T therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. There will be no treatment administered during the study and the data obtained from this study will help to assess whether there will be long-term cilta-cel-related toxicities. The study will consist of 2 phases: within the first 5 years after receiving the last dose of cilta-cel and Year 6 to 15 years after last dose of cilta-cel. Safety evaluations will include a review of adverse events, laboratory test results, and physical examination findings (including neurological examination). The duration of the study is up to 15 years after last dose of cilta-cel and participants will be followed at least once per year.

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Phase 4

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Recruiting
    • UZ Gent
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
• China
  • Beijing, China, 100191
    • Recruiting
    • Peking University Third Hospital
  • Chengdu, China, 610041
    • Recruiting
    • West China Hospital, Si Chuan University
  • Fuzhou, China, 350000
    • Recruiting
    • Fujian Medical University Union Hospital
  • Hangzhou, China, 310003
    • Recruiting
    • First Hospital, Zhejiang University Medical College
  • Nanjing, China, 210029
    • Recruiting
    • Jiangsu Province Hospital
  • Shanghai, China, 200025
    • Recruiting
    • Ruijin Hospital, Shanghai Jiao Tong University
  • Shanghai, China, 200434
    • Recruiting
    • Shanghai Fourth People's Hospital
  • Xi'an, China, 710004
    • Recruiting
    • The Second Affiliated Hospital of Xi'an Jiaotong University
• Israel
  • Tel-Aviv, Israel, 64239
    • Recruiting
    • Tel-Aviv Sourasky Medical Center
• Japan
  • Nagoya, Japan, 467 8602
    • Active, not recruiting
    • Nagoya City University Hospital
  • Shibuya, Japan, 150-8935
    • Active, not recruiting
    • Japanese Red Cross Medical Center
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Recruiting
    • VU Medisch Centrum
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • University Medical Center Groningen
• Spain
  • Pamplona, Spain, 31008
    • Recruiting
    • Clinica Univ. de Navarra
  • Salamanca, Spain, 37007
    • Recruiting
    • Hosp. Clinico Univ. de Salamanca
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Cancer Center-Scottsdale
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
  • Kansas
    • Westwood, Kansas, United States, 66205
      • Recruiting
      • Kansas University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Barbara Ann Karmanos Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Recruiting
      • Mayo Clinic Rochester
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack University Medical Center
    • New Brunswick, New Jersey, United States, 08903
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Levine Cancer Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Sarah Cannon Research Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Memorial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cilta-cel; 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; 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.; Other Names: JNJ-68284528; LCAR-B38M CAR-T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood	Number of participants with measurable RCL in peripheral blood will be reported.	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	Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported.	Up to 15 years
Pattern of Lentiviral Vector Integration Sites	Pattern of lentiviral vector integration sites if at least 1 percent (%) of cells in the blood sample or new malignancy are positive for vector sequences will be reported.	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	Investigator's response assessment of long term follow-up on CAR-T therapy based on local lab assessments if the participant does not have confirmed disease progression or does not initiate subsequent anti-myeloma therapy at the entry of the study and at any time of during the study will be reported.	Up to 15 years
Overall Survival (OS)	OS is measured from the date of randomization to the date of the participant's death.	Up to 15 years

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Estimated): July 29, 2037
• Study Completion (Estimated): July 29, 2037

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Multiple Myeloma
• Other Study ID Numbers: CR109123; 2020-005521-84 (EudraCT Number); 68284528MMY4002 (Other Identifier: Janssen Research & Development, LLC); 2023-505530-10-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No