A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cilta-cel Participants who had previously received treatment with cilta-cel in a Company-sponsored clinical study (example, NCT04923893, NCT04181827, 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. 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:
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Outcome Measures
Primary Outcome Measures
- 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 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 Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia [Up to 15 years]
Number of participants with new incidence of Grade >=3 hematologic disorder including hypogammaglobulinemia will be reported.
- Number of Participants with New Incidence of Grade >= 3 Infection [Up to 15 years]
Number of participants with new incidence of Grade >=3 infection will be reported.
- Number of Participants with Serious Adverse Events (SAEs) [Up to 15 years]
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
- 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.
- 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.
- Overall Survival (OS) [Up to 15 years]
OS is measured from the date of randomization to the date of the participant's death.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
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Participants who have provided informed consent for this study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic Cancer Center-Scottsdale | Phoenix | Arizona | United States | 85054 |
2 | City of Hope | Duarte | California | United States | 91010 |
3 | University of California, San Francisco | San Francisco | California | United States | 94143 |
4 | University of Chicago | Chicago | Illinois | United States | 60637 |
5 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
6 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02215 |
7 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
8 | Mayo Clinic Rochester | Rochester | Minnesota | United States | 55902 |
9 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
10 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
11 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
12 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
13 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
14 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
15 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15232 |
16 | Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
17 | Froedtert Memorial | Milwaukee | Wisconsin | United States | 53226 |
18 | UZ Gent | Gent | Belgium | 9000 | |
19 | UZ Leuven | Leuven | Belgium | 3000 | |
20 | Peking University Third Hospital | Beijing | China | 100191 | |
21 | Fujian Medical University Union Hospital | Fuzhou | China | 350000 | |
22 | First Hospital, Zhejiang University Medical College | Hangzhou | China | 310003 | |
23 | Jiangsu Province Hospital | Nanjing | China | 210029 | |
24 | Shanghai Changzheng Hospital | Shanghai | China | 200003 | |
25 | Ruijin Hospital, Shanghai Jiao Tong University | Shanghai | China | 200025 | |
26 | Sheba Medical Center | Ramat Gan | Israel | 57261 | |
27 | Tel-Aviv Sourasky Medical Center | Tel-Aviv | Israel | 64239 | |
28 | Nagoya City University Hospital | Nagoya | Japan | 467-8602 | |
29 | Japanese Red Cross Medical Center | Shibuya | Japan | 150-8935 | |
30 | Clinica Univ. de Navarra | Pamplona | Spain | 31008 | |
31 | Hosp. Clinico Univ. de Salamanca | Salamanca | Spain | 37007 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109123
- 2020-005521-84
- 68284528MMY4002