Phase 1/2 Trial for Immix Biopharma’s AL Amyloidosis CAR-T NXC-201 Hits Over 50% Enrollment

The phase 1b/2 NEXICART-2 clinical trial (NCT06097832), which is evaluating Immix Biopharma and its subsidiary Nexcella's NXC-201, an investigational autologous BCMA-directed chimeric antigen receptor T-cell (CAR-T) therapy, for the treatment of relapsed/refractory (r/r) light chain (AL) amyloidosis, has reached over 50% of its planned enrollment.¹

The trial, which is taking place in the United States, is expected to enroll 40 patients in total. According to the clinicaltrials.gov page for NEXICART-2, which was most recently updated on July 10, 2025, the study is currently recruiting at sites in California, Michigan, New York, Ohio, Georgia, Kansas, Massachusetts, Missouri, Tennessee, Utah, and Washington. Interim data from the trial were most recently presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 30 to June 3, in Chicago, Illinois.² Notably, the therapy has previously received regenerative medicine advanced therapy (RMAT) designation and orphan drug designation (ODD) from the FDA, as well as ODD from the European Medicines Agency.¹

“With excitement generated by our clinical results presented at ASCO, surpassing 50% enrollment in NEXICART-2 demonstrates the growing interest among r/r AL Amyloidosis clinicians and patients, where no drugs are FDA approved today,” Ilya Rachman, MD, PhD, the chief executive officer of Immix Biopharma, said in a statement.¹

The results reported in the ASCO abstract included 7 patients treated in the trial, whose follow-up ranged from 7 to 209 days (median, 97).² At Day 25 or Day 26 posttreatment, 5 of the 6 patients with minimal residual disease (MRD) data available as of the data cutoff showed MRD negativity in the bone marrow at a sensitivity of 10^-6. First author Heather Landau, MD, the MSKCC Amyloidosis Program director and the NEXICART-2 principal study investigator, and colleagues also noted that as of the abstract’s data cut-off, all of the 7 patients were in a state of complete response or very good partial response, and no relapses had occurred.

In terms of safety, grade 1 cases of cytokine release syndrome (CRS) occurred in 4 patients and a case of grade 2 CRS occurred in 1 patient. Neurotoxicity, febrile neutropenia, treatment-related infections, and cardiac toxicity were not reported in any patient and none of the patients had died.

“In this first reported US CAR-T clinical trial experience in r/r AL amyloidosis, we demonstrate that NXC-201 can be given safely and resulted in rapid and deep hematologic responses in all patients treated,” Landau and colleagues wrote in the ASCO abstract.² “Our data suggests that the novel antiBCMA CAR-T NXC-201 may become a valuable treatment option for r/r AL patients.”

On-site at ASCO, CGTLive®’s sister site, OncLive®, also spoke with Shahzad Raza, MD, a hematologist/oncologist at the Cleveland Clinic who coauthored the study presented at the conference. Raza went over the key results and their implications and also spoke about future plans for evaluating the CAR-T product in AL amyloidosis, along with unanswered questions and challenges that still need to be addressed. Raza emphasized that while patients with advanced cardiac amyloidosis (stage 3b) were excluded from the current trial, future studies should explore its use in this high-risk group if safety and efficacy continue to hold. Raza also stressed the urgent need for effective second-line treatments and suggested offering CAR-T therapy earlier in the disease course.

“So far, the data is quite promising to share that this is very safe...” Raza told OncLive. “I'm hoping that by the next 6 months, we will have much more mature data, more patients enrolled... The phase 1b and phase 2a is quite exciting. This data does show it's a safe drug and can be given safely to the patients.”

REFERENCES
1. Immix Biopharma announces 50% enrollment milestone surpassed in its ongoing relapsed/refractory AL amyloidosis clinical trial, NEXICART-2. News release. September 18, 2025. Accessed September 18, 2025. https://immixbio.com/immix-biopharma-announces-50-enrollment-milestone-surpassed-in-its-ongoing-relapsed-refractory-al-amyloidosis-clinical-trial-nexicart-2/
2. Landau H. Safety and efficacy data from Nexicart-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, NXC-201. Presented at the 2025 ASCO Annual Meeting, held May 30 to June 3, in Chicago, Illinois. Abstract #7508