Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
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.
Arms & interventions
- DrugCilta-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.
Outcome measures
Primary
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From year 6 up to year 15
Secondary
Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
Time frame: 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
Time frame: Up to 15 years
Pattern of Lentiviral Vector Integration Sites
Time frame: 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
Time frame: Up to 15 years
Overall Survival (OS)
Time frame: Up to 15 years
Eligibility criteria
Study locations (28)
Mayo Clinic Cancer Center-Scottsdale
Phoenix, Arizona, 85054
City of Hope
Duarte, California, 91010
University of California San Francisco
San Francisco, California, 94143
Stanford University Medical Center
Stanford, California, 94305-5623
Moffitt Cancer Center
Tampa, Florida, 33612
Emory University
Atlanta, Georgia, 30322
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Indiana University
Indianapolis, Indiana, 46202
Kansas University Medical Center
Westwood, Kansas, 66205
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 02215
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Mayo Clinic Rochester
Rochester, Minnesota, 55902
Washington University School Of Medicine
St Louis, Missouri, 63110
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Roswell Park Cancer Institute
Buffalo, New York, 14263
Mount Sinai Medical Center
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Montefiore Medical Center
The Bronx, New York, 10467
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
MD Anderson Cancer Center
Houston, Texas, 77030
Froedtert Memorial
Milwaukee, Wisconsin, 53226