A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
- Registration Number
- NCT05201781
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 228
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cilta-cel 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.
- Primary Outcome Measures
Name Time Method Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder Up to 15 years Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.
Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder Up to 15 years Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported.
Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy Up to 15 years Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.
Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia From year 6 up to year 15 Number of participants with serious hematologic disorder, including hypogammaglobulinemia will be reported. Serious hematologic disorder, includes hypogammaglobulinemia (all grades, regardless of causality).
Number of Participants with Serious Infection From year 6 up to year 15 Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality.
Number of Participants with New Incidence of Grade >= 3 Infection From year 1 up to year 5 Number of participants with new incidence of Grade \>=3 infection will be reported.
Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia From year 1 up to year 5 Number of participants with new incidence of Grade \>=3 hematologic disorder including hypogammaglobulinemia will be reported.
Number of Participants with Serious Adverse Events (SAEs) From year 1 up to year 5 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.
Number of Participants with Related Serious Adverse Events Assessed by the Investigator From year 6 up to year 15 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.
- Secondary Outcome Measures
Name Time Method Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood Up to 15 years Number of participants with measurable RCL in peripheral blood will be reported.
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 Number of participants with CAR transgene level \>LLOQ in peripheral blood cells will be reported.
Pattern of Lentiviral Vector Integration Sites Up to 15 years 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.
Overall Survival (OS) Up to 15 years OS is measured from the date of randomization to the date of the participant's death.
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 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.
Trial Locations
- Locations (47)
Clinica Univ. de Navarra
🇪🇸Pamplona, Spain
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Mayo Clinic Cancer Center-Scottsdale
🇺🇸Phoenix, Arizona, United States
City of Hope
🇺🇸Duarte, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Kansas University Medical Center
🇺🇸Westwood, Kansas, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Washington University School Of Medicine
🇺🇸Saint Louis, Missouri, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Froedtert Memorial
🇺🇸Milwaukee, Wisconsin, United States
UZ Gent
🇧🇪Gent, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Peking University Third Hospital
🇨🇳Beijing, China
West China Hospital Si Chuan University
🇨🇳Chengdu, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, China
First Hospital, Zhejiang University Medical College
🇨🇳Hangzhou, China
Jiangsu Province Hospital
🇨🇳Nanjing, China
Ruijin Hospital Shanghai Jiao Tong University
🇨🇳Shanghai, China
Shanghai Fourth People s Hospital
🇨🇳Shanghai, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
CHRU de Lille Hopital Claude Huriez
🇫🇷Nord, France
Hopital Saint Louis
🇫🇷Paris, France
Tel Aviv Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Nagoya City University Hospital
🇯🇵Nagoya, Japan
Japanese Red Cross Medical Center
🇯🇵Shibuya, Japan
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Hosp Clinico Univ de Salamanca
🇪🇸Salamanca, Spain