04:12 PM EDT, 04/18/2024 (MT Newswires) -- Immix Biopharma ( IMMX ) Thursday said it is on track to dose first patients with relapsed or refractory AL Amyloidosis with its CAR-T NXC-201 therapy candidate by mid-2024 after scheduling initiation visits at US testing locations this month and May.
The open-label, phase 1b dose-expansion trial is expected to enroll around 40 patients with adequate cardiac function and will evaluate the safety and efficacy of NXC-201 over an 18-month span. The primary endpoints are complete response rate and overall response rate.
NXC-201 has received orphan-drug designation from the US Food and Drug Administration and European regulators as a prospective treatment for AL Amyloidosis. The FDA also designating the therapy as an orphan drug to treat multiple myeloma.
Immix Biopharma ( IMMX ) dropped more than 11% during regular trading hours.