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Adult B-cell acute lymphoblastic leukemia (B-ALL) has a poor prognosis
.
There is currently no CD19 chimeric antigen receptor (CAR) therapy approved to treat this disease
.
The multicenter Phase 1 ALLCAR19 trial evaluated the safety and preliminary efficacy of autologous CAT19-41BB-Z CAR T cells (AUTO1) in relapsed or refractory (r/r) adult B-ALL patients
.
The trial recruited r/r B-ALL patients who were 16 years of age and older
.
The primary endpoint is toxicity and the feasibility of CAR T cell preparation
.
CAR-T
Twenty-five patients underwent leukocyte depletion, 24 patients successfully prepared CAR T cells, and finally 20 patients were infused with AUTO1
.
The median age of the tested patients was 41.
5 years old, 25% of them had been treated with Bonatumumab, 50% had been treated with Ituzumab ozogamicin, and 65% had had allogeneic stem cell transplantation
25 patients underwent leukocyte depletion, 24 patients successfully prepared CAR T cells, and finally 20 patients were infused with AUTO1 stem cells
Adverse events
Adverse eventsNo patient had a cytokine release syndrome ≥ grade 3
.
Three of the 20 patients (15%) developed Grade 3 neurotoxicity, which was reduced to ≤ Grade 1 within 72 hours of steroid use
.
No patient had a cytokine release syndrome ≥ grade 3 No patient had a cytokine release syndrome ≥ grade 3
Progression-free survival and overall survival
Progression-free survival and overall survivalThe event-free survival rates at the 6th and 12th months were 68.
3% (95%CI 42.
4-84.
4) and 48.
3 (23.
1-69.
7), respectively
.
At the last follow-up, 15 of the 20 patients had persistent B-cell aplasia, and high-level amplification (Cmax 127152 copies/μg genomic DNA) and long-lasting CAR-T persistence were observed
.
The event-free survival rates at the 6th and 12th months were 68.
In r/r adult B-ALL patients, AUTO1 showed tolerable safety, high remission rate and excellent duration.
Original source:
Claire Roddie, et al.
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