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Long-term Follow-up Study for Participants Previously Treated with Ciltacabtagene Autoleucel company-sponsored clinical studies.
Study on Long-term Effects of Investigational Treatment
R
Rafat Abonour, MD
Primary Investigator
Not Recruiting
18 years - 100 years
All
Phase
N/A
2 participants needed
1 Location
Brief description of study
This is an interventional long-term follow-up study to collect data on delayed adverse events after administration of cilta-cel in a previous clinical study, and to characterize and understand the long-term safety profile of cilta-cel.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
- All subjects who received treatment with cilta-cel in a Company-sponsored clinical study in the global development program will be offered enrolment into Study MMY4002 once the individual’s participation in the particular interventional study has ended or after a study has been terminated.
- Subjects post-CAR-T infusion who discontinue prior to completion of individual studies will be offered enrollment in this study. Subjects who had disease progression and had initiated subsequent antitumor therapy will also be eligible for enrollment into this study.
- No additional study treatment will be administered to subjects in Study MMY4002.
- 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. An ad-hoc visit between scheduled visits may be conducted if warranted.
- The study will report the preliminary results in a dedicated section of the annual safety update report, eg, development safety update report (DSUR) or periodic benefit-risk evaluation report (PBRER). In addition, the study results will be summarized and reported in a periodic clinical study report (CSR) every 3 years. At the end of the study, a final CSR will be issued.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cancer
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
- Criterion modified per Amendment 1
- Subjects who have received at least one dose of cilta-cel in a Company-sponsored
clinical study. - Subjects who have provided informed consent for Study MMY4002.
This study investigates the long-term effects of an investigational treatment used in previous clinical trials. The purpose is to collect data on delayed adverse events and to understand the safety profile over an extended period. Participants are those who have already received the investigational treatment in earlier studies.
In this study, participants will not receive any additional treatment. The study will observe participants for up to 15 years, with specific phases within the first 5 years and from Year 6 to Year 15. Participants may have additional visits if needed to monitor safety.
- Who can participate: Participants who have received at least one dose of the investigational treatment in a previous company-sponsored study and have provided informed consent are eligible.
- Study details: Data will be collected on any delayed adverse events to assess the long-term safety of the investigational treatment.
- Study timelines: The study will last 15 years.
Updated on
23 Sep 2025.
Study ID: CTO-68284528MMY4002, 19186
