Clinical TrialMay 21, 2026, 06:02 AM
ImmixBio NEXICART-2 CR rate 95%; all MRD-negative patients convert to CR
AI Summary
Immix Biopharma announced strong results from its NEXICART-2 Phase 2 clinical trial for NXC-201 in relapsed/refractory AL Amyloidosis. The complete response (CR) rate reached 95% (19 of 20 patients), with all four previously MRD-negative patients converting to CR. No relapses have been observed for patients who reached CR, and all subsequently enrolled patients with available MRD results are MRD-negative at one month. The company plans to initiate a Phase 3 trial and expects to present 1-year follow-up data by March 2027, aiming for BLA submission and commercial launch.
Key Highlights
- NEXICART-2 trial achieved a 95% complete response (CR) rate (19 of 20 patients).
- All four previously MRD-negative patients converted to complete response.
- No relapses observed to date for patients who have reached complete response.
- All subsequently enrolled patients with available MRD results are MRD-negative at one month.
- ImmixBio plans to initiate a multi-center, randomized Phase 3 trial for NXC-201.
- Next NEXICART-2 update is expected in late September 2026.
- Company expects 1-year follow-up data by March 2027 to drive BLA submission.
- NXC-201 holds FDA Breakthrough Therapy, RMAT, and Orphan Drug Designations.
Price Impact
More from IMMX