KTE-C19-108: Phase1/2 study of KTE-C19 in subjects with R/R CLL
Research type
Research Study
Full title
A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia
IRAS ID
253442
Contact name
Peter Hillmen
Contact email
Sponsor organisation
Kite Pharma, Inc
Eudract number
2018-001923-38
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
16675, IND
Duration of Study in the UK
16 years, 6 months, 1 days
Research summary
Research Summary:
Chronic lymphocytic leukaemia (CLL) is the most commonly occurring leukaemia in Europe and the US. This research study is being conducted in adult participants with relapsed or refractory (r/r) CLL, to find out if a treatment known as KTE-C19 is safe and effective in treating CLL, as currently available treatments do not provide durable responses or a cure for patients. The experimental treatment (KTE-C19) in this study removes some of the participants immune cells, genetically engineers those cells to identify and kill cancer cells, and gives the participant back those cells in an infusion.
There will be 2 phases to this study. Phase 1 will enrol participants (up to 48) to evaluate the safety of KTE-C19. Based on the safety of this phase, more participants might be enrolled into this phase or enrolled into phase 2 of this study. During phase 2 of this study, participants (approximately 60) will be assessed to evaluate the efficacy and safety of KTE-C19. All participants in this study will receive conditioning chemotherapy (to prepare the participant for the KTE-C19 treatment) followed by the KTE-C19 treatment. All participants will be hospitalised to receive the KTE-C19 infusion followed by a minimum 7 day observation period. The duration of participation in this study may last up to 15 years. Visits will be more frequent at the start of the study but then will become less frequent when participants enter long-term follow-up (after 3 months).
During the study, participants in phase 1 will undergo a number of different procedures as per study protocol. Participants enrolled in part 2 will also undergo the same study procedures but will also complete questionnaires for patient reported outcomes.
Summary of Results:
A total of 16 participants were enrolled (ie, leukapheresed), of whom 15 were subsequently treated with brexucabtagene autoleucel. Infusion of brexucabtagene autoleucel was completed for all 15 participants.
As of the database finalisation on 11 January 2023, the actual median follow-up time from brexucabtagene autoleucel infusion was 24.38 months (range: 2.7 to 41.5 months).
All 15 participants treated with brexucabtagene autoleucel completed the study. Six participants (38%) died, 2 participants (13%) withdrew consent, and 7 participants (44%) had other reasons for ending the study (1 participant was lost to follow-up, 1 participant chose not to rollover to the LTFU study KT-US-982-5968, and the remaining 5 participants rolled over to KT-US-982-5968).
The median age at enrolment was 63 years (range: 52 to 79 years), and 6 participants (40%) were ≥ 65 years old. Most participants were male (10 participants, 67%), White (13 participants, 87%), and were treated in the US (14 participants, 93%). None of the participants were known to be Hispanic or Latino. Fourteen participants were diagnosed with CLL, and 1 participant was diagnosed with SLL. Most participants had advanced disease; the median time from diagnosis to enrolment was 10.37 years (range: 3.3 to 18.8 years) and they had received > 3 prior lines of therapy (12 subjects, 80%). At baseline, the median ALC was 2.2 × 109 cells/L (range: 0.03 to 33.99 × 109 cells/L) and the median tumour burden by the sum of product diameters was 2308.50 mm2 (range: 464.0 to 26688.3 mm2).
REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0118
Date of REC Opinion
8 Jul 2019
REC opinion
Further Information Favourable Opinion