CARTinue
Multiple myeloma
A Phase 4, long-term follow-up study of participants previously treated with
cilta-cel (anti-BCMA CAR T-cell therapy) for MM
Phase
Compound
No intervention (previously received cilta-cel [anti-BCMA CAR T-cell therapy])
NCT identifier
NCT05201781
Enrollment
N=~295
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria:
- Received ≥1 dose of cilta-cel in a Johnson & Johnson R&D-sponsored clinical study
Study
design
Primary outcomes:
- New malignancies/recurrence of pre-existing malignancy
- New incidence or exacerbation of a pre-existing neurologic, rheumatologic, or other autoimmune disorder
- Grade ≥3 hematologic disorder or infection
- SAEs
Secondary outcomes:
- Measurable RCL in peripheral blood
- CAR transgene level greater than the LLOQ in peripheral blood
- Pattern of lentiviral vector integration sites
- Investigator’s CAR T-cell response assessment*
- OS
*Based on local laboratory assessments.
BCMA, B-cell maturation antigen; CAR, chimeric antigen receptor; cilta-cel, ciltacabtagene autoleucel; LLOQ, lower limit of quantification; MM, multiple myeloma; OS, overall survival; R&D, research and development; RCL, replication competent lentivirus; SAE, serious adverse event.