P1, N=60, Not yet recruiting, Tongji Hospital | Trial completion date: Oct 2027 --> Feb 2029 | Initiation date: Mar 2025 --> Feb 2026 | Trial primary completion date: Oct 2027 --> Feb 2028
28 days ago
Trial completion date • Trial initiation date • Trial primary completion date
P1, N=68, Recruiting, University of Colorado, Denver | N=20 --> 68 | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
1 month ago
Enrollment change • Trial completion date • Trial primary completion date
The CD22/CD19 CAR T-cell and auto-HSCT sandwich strategy represents a promising approach for the treatment of Ph-negative B-ALL in AYA and adult patients, offering high efficacy and a favorable safety profile. The trial registration is ClinicalTrials.gov identifier NCT05470777.
CAR T-cell expansion was similar, except for patients who had extramedullary disease with low bone marrow disease burden (n = 6 from each group), for whom BC-manufactured cells had greater expansion. In summary, while efficacy across both platforms was comparable, lower inflammatory markers in those who received Prodigy manufactured CAR T-cells suggest changes in the infusion product.