Study KTE-C19-102 (NCT02601313) enrolled participants with r/r MCL who had been treated with up to 5 prior regimens, including a BTKi, in Cohorts 1 and 2. To fulfill an FDA postmarketing requirement, Cohort 3 is added to the study. Cohort 3 includes participants with r/r MCL who have been treated with up to five prior regimens but have not received prior therapy with a BTKi.
The final analysis for Cohorts 1 and 2 has been completed. Data for Cohort 3 are analyzed separately. Therefore, this separate registration is only for Cohort 3.
After the end of KTE-C19-102, subjects who received an infusion of anti-CD19 CAR T cells will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968 (NCT05041309).
