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Clinical trial

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

ID
Name
CR109123
Description
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.
Trial arms
Trial start
2022-03-09
Estimated PCD
2037-07-29
Trial end
2037-07-29
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Cilta-cel
Other names:
JNJ-68284528, LCAR-B38M CAR-T cells
Size
228
Primary endpoint
Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy
Up to 15 years
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 Rheumatologic or Other Autoimmune Disorder
Up to 15 years
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 Serious Hematologic Disorder, including Hypogammaglobulinemia
From year 6 up to year 15
Number of Participants with New Incidence of Grade >= 3 Infection
From year 1 up to year 5
Number of Participants with Serious Infection
From year 6 up to year 15
Number of Participants with Serious Adverse Events (SAEs)
From year 1 up to year 5
Number of Participants with Related Serious Adverse Events Assessed by the Investigator
From year 6 up to year 15
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 228, 'type': 'ESTIMATED'}}
Updated at
2024-05-23

1 organization

1 product

1 indication

Organization
Janssen Research & Development
Product
Cilta-cel
Indication
Multiple Myeloma