NCT05201781

A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 295 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-09
• Primary completion: 2037-07-29
• Completion: 2038-01-26
• First posted: 2022-01-21
• Last updated: 2026-04-13

Locations

50 sites across 8 countries: United States, Belgium, China, France, Israel, Japan, Netherlands, Spain

Regulatory

• FDA-regulated drug study