OrcaGraft (engineered donor allograft cell therapy)

P1, N=186, Recruiting, Orca Biosystems, Inc. | Trial completion date: Apr 2026 --> Apr 2028 | Trial primary completion date: Apr 2024 --> Apr 2026

RESULTS Orca-Q was successfully manufactured and delivered to all subjects with a vein-to-vein time (time between end of donor apheresis to start of recipient's Orca-T infusion) of < 72 hours...Sixteen patients received TBI-based MAC; 17 received busulfan-based MAC (Table)...With median follow-up of approximately 1 year, no patients experienced moderate or severe cGvHD, the low AE profile in the haplo setting remains favorable, and 1 year GvHD-free, relapse-free survival of 83% is very encouraging. This phase 1 study continues to enroll patients across the US.

P1/2, N=40, Recruiting, University of Florida | Suspended --> Recruiting

Background: Allogeneic stem cell transplantation (SCT) can be curative for high-risk (HR) hematologic malignancies, but until recently, access was limited to fully matched donors. Our findings suggest encouraging safety and efficacy outcomes using Orca-Q cell therapy for haplo-SCT, without PTCy, and only single agent tacrolimus. Patients treated with Orca-Q experienced a low adverse event profile, low incidence of overall and severe aGvHD/cGvHD, and improved GRFS. This phase 1 study continues to enroll patients across the US.

P1/2, N=40, Suspended, University of Florida | Recruiting --> Suspended

Patients treated with Orca-Q experienced a low adverse event profile, low incidence of overall and severe aGvHD/cGvHD, and an improved GRFS rate. This phase 1 study continues to enroll patients across the US.

P1/2, N=40, Not yet recruiting, University of Florida