Immix Biopharma Completes Enrollment for Key AL Amyloidosis Trial

Topline results expected in Q3 2026, followed by BLA submission and planned commercial launch

Mar. 30, 2026 at 2:07pm

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Immix Biopharma, Inc. announced that enrollment is complete for the NEXICART-2 trial, a multi-site U.S. Phase 2 clinical trial of its sterically-optimized CAR-T therapy NXC-201 in relapsed/refractory AL Amyloidosis. Topline results are expected in Q3 2026, which will drive the company's BLA submission and planned commercial launch. The company also onboarded a new Chief Medical Officer with extensive experience in drug approvals.

Why it matters

AL Amyloidosis is a devastating disease where the immune system produces toxic light chains that clog up vital organs, leading to organ failure and death. If approved, NXC-201 would be the first FDA-approved treatment for relapsed/refractory AL Amyloidosis, addressing a growing patient population estimated to reach 38,500 in the U.S. by 2026.

The details

NEXICART-2 is a 40-patient registrational study evaluating NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy designed to filter out non-specific activation and teach the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has received Breakthrough Therapy Designation, RMAT, and Orphan Drug Designation from the FDA and EMA.

  • Enrollment for the NEXICART-2 trial is now complete, meeting the company's prior guidance.
  • Topline NEXICART-2 results are expected in Q3 2026.
  • Following the topline results, Immix plans to submit a BLA and launch the product commercially.

The players

Immix Biopharma, Inc.

A biopharmaceutical company and the global leader in relapsed/refractory AL Amyloidosis, developing the CAR-T therapy NXC-201.

Ilya Rachman, MD, PhD

Chief Executive Officer of Immix Biopharma.

Gabriel Morris

Chief Financial Officer of Immix Biopharma.

Richard Graydon, MD, PhD

The new Chief Medical Officer of Immix Biopharma, with over 20 years of experience in clinical development and leading drug approvals at Merck and Johnson & Johnson.

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What they’re saying

“In AL Amyloidosis, the immune system produces toxic light chains that clog up the heart, kidney and liver, causing organ failure and death. In our trials, we have seen that one-and-done NXC-201 eliminates the source of these toxic light chains. If approved, NXC-201 would be the first FDA approved treatment for relapsed/refractory AL Amyloidosis.”

— Ilya Rachman, Chief Executive Officer, Immix Biopharma

“We are grateful to patients, families, caregivers, investigators, and credit our team's tireless efforts. Building on our positive interim readout at ASH 2025, topline NEXICART-2 results are expected in Q3, driving BLA submission and planned commercial launch.”

— Gabriel Morris, Chief Financial Officer, Immix Biopharma

What’s next

Following the expected topline NEXICART-2 results in Q3 2026, Immix plans to submit a Biologics License Application (BLA) and launch the product commercially.

The takeaway

The completion of enrollment for the NEXICART-2 trial marks a significant milestone in Immix Biopharma's efforts to develop the first FDA-approved treatment for relapsed/refractory AL Amyloidosis, a devastating disease with a growing patient population. The onboarding of an experienced Chief Medical Officer further strengthens the company's capabilities as it prepares for the upcoming BLA submission and commercial launch.