firicabtagene autoleucel (CRG-022)

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.

P1, N=22, Active, not recruiting, Stanford University | Trial completion date: Jan 2037 --> May 2026 | Trial primary completion date: Jan 2037 --> May 2026 | Recruiting --> Active, not recruiting

P1, N=52, Completed, Stanford University | Active, not recruiting --> Completed | Trial completion date: Dec 2037 --> Mar 2025

P1, N=20, Recruiting, Stanford University | Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Jun 2025 --> Nov 2025

High and low percentages of CAR22 TCM and TEM, respectively, were correlated with CAR22 transduction efficiency and achieving complete response. Residual CAR19 and leukapheresis timing did not significantly affect outcomes, while CAR22 product composition was significantly correlated with treatment response.

Myeloablative conditioning with cyclophosphamide and total body irradiation precede infusion of investigational Orca-T, which consists of infusions of HSPCs and Tregs on Day 0 and an infusion of T conventional (Tcon) cells on Day 2. This paradigm shifting combination of allogeneic CAR T and allo-HCT resulted in 100% MRD- CR with full donor chimerism but without GVHD or severe CAR-mediated toxicity. These data, which demonstrate antigen-specific anti-tumor benefit of allogeneic CAR T cells in combination with GVHD prophylaxis mediated by Tregs and tacrolimus, have potential implications that could benefit patients with other hematologic diseases.

P1, N=20, Recruiting, Stanford University | Not yet recruiting --> Recruiting

P1, N=20, Not yet recruiting, Stanford University

Duration of response was overall limited (median 77 days), and CD22 expression was downregulated in 4/12 (33%) available samples at relapse. In summary, we demonstrate that closed-loop manufacturing of CD22-CAR T cells is feasible and is associated with a favorable safety profile and high CR rates in pediatric and adult r/r B-ALL, a cohort with limited CD22-CAR reporting.

P1, N=52, Active, not recruiting, Stanford University | Trial completion date: Dec 2024 --> Dec 2037

P1, N=10, Active, not recruiting, Stanford University | Suspended --> Active, not recruiting | N=52 --> 10 | Trial completion date: Aug 2035 --> Sep 2036 | Trial primary completion date: Aug 2025 --> Oct 2023

P1, N=52, Active, not recruiting, Stanford University | Recruiting --> Active, not recruiting | N=92 --> 52 | Trial completion date: Sep 2034 --> Dec 2024 | Trial primary completion date: Apr 2023 --> Dec 2024