Drugs / NXC-201
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04720313 | Jan 2021 → Jan 2026 overdue | — | Hadassah Medical Organization | Active not recruiting | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT06097832 | Jun 2024 → Dec 2026 expected | AL amyloidosis | Nexcella Inc. | Active not recruiting | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT07709715 | Jan 2027 → Dec 2028 expected | AL amyloidosis | Nexcella Inc. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 42
| Date | Issuer | Release |
|---|---|---|
| 2026-09-29 | Immix Biopharma, Inc. | Results Immix Biopharma Announces 89% Complete Response Rate at Interim Update Across All NEXICART-2 Patients, with MRD-Negativity Indicating Potential to Reach up to 98% Complete Response Rate, Supporting Potential Best-in-Class Therapy for Relapsed/Refractory AL Amyloidosis immixbio.com ↗
Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), a global leader in relapsed/refractory AL Amyloidosis, today announced positive results of an 89% (40/45) complete response (CR) rate in an interim update across all forty-five NEXICART-2 patients, advancing NXC-201 as a potential best-in-class therapy for AL Amyloidosis. |
| 2026-05-21 | Immix Biopharma, Inc. | Results Immix Biopharma Announces 95% Complete Response Rate in Interim Update From relapsed/refractory AL Amyloidosis Clinical Trial NEXICART-2 immixbio.com ↗
The NEXICART-2 CR rate is now 95% (19 out of 20 patients). |
| 2026-01-28 | Immix Biopharma, Inc. | Regulatory Immix Biopharma Receives U.S. FDA Breakthrough Therapy Designation for NXC-201 immixbio.com ↗
Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), the global leader in relapsed/refractory AL Amyloidosis, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to NXC-201 for the treatment of relapsed/refractory AL Amyloidosis. |
| 2025-12-07 | Immix Biopharma, Inc. | Results At ASH 2025 Oral Presentation, Immix Biopharma Reports Positive Phase 2 NXC-201 Results, Advancing Toward BLA Submission as a Potentially First- and Best-in-Class Therapy for relapsed/refractory AL Amyloidosis immixbio.com ↗
NXC-201 demonstrated a complete response (CR) rate of 75% (15/20) (at s/u IFE(-) level) by independent review committee. |
| 2025-07-11 | Immix Biopharma, Inc. | Results Immix Biopharma Announces Class-Leading Safety Profile, Allowing Potential Future Indication Expansion immixbio.com ↗
Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced a class-leading safety profile for sterically-optimized CAR-T NXC-201, including absence of neurotoxicity of any grade in low-volume disease to-date, laying a foundation for potential future indication expansion. |
| 2025-06-03 | Immix Biopharma, Inc. | Results Immix Biopharma Announces Primary Endpoint Met in positive NXC-201 Interim Results Presented at ASCO, Enabling Path to Best-in-Class Therapy for relapsed/refractory AL Amyloidosis immixbio.com ↗
Immix Biopharma today presented results at ASCO from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201, meeting its primary endpoint. |
| 2025-05-22 | Immix Biopharma, Inc. | Results Immix Biopharma Announces Positive Results for NXC-201 at ASCO Oral Presentation, Enabling Pathway to Best-in-Class Therapy for relapsed/refractory AL Amyloidosis immixbio.com ↗
Immix Biopharma today reported ASCO abstract results from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201 demonstrating strong efficacy and favorable safety. |
| 2025-02-10 | Immix Biopharma, Inc. | Regulatory Immix Biopharma Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for NXC-201, sterically-optimized CAR-T for relapsed/refractory AL Amyloidosis immixbio.com ↗
Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL amyloidosis and select immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted RMAT designation to sterically-optimized CAR-T NXC-201 for the treatment of relapsed/refractory AL amyloidosis. |
| 2024-12-19 | Immix Biopharma, Inc. | Results Immix Biopharma Announces Positive U.S. Clinical Data From First Four Patients in NEXICART-2 U.S. Trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory Light Chain (AL) Amyloidosis immixbio.com ↗
NEXICART-2 opened for enrollment June 2024 and this is the first clinical data being reported from the study. |
| 2024-12-16 | Immix Biopharma, Inc. | Results Journal of Clinical Oncology Publishes NXC-201 Positive Clinical Results in relapsed/refractory AL Amyloidosis immixbio.com ↗
Results showed a complete response (CR) rate of 75% (12/16). |
| 2024-12-10 | Immix Biopharma, Inc. | Results Immix Biopharma Announces 75% Complete Response Rate (n=16); 31.5 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2024 immixbio.com ↗
The updated results include follow-up and clinical data from 3 new NEXICART-1 patients. |
| 2024-11-25 | Immix Biopharma, Inc. | Results Immix Biopharma Presents Positive NXC-201 Clinical Data at 66th American Society of Hematology (ASH) Annual Meeting in 16 Relapsed/Refractory AL Amyloidosis Patients immixbio.com ↗
75% (12/16) complete response rate observed in relapsed/refractory AL Amyloidosis patients with median 4 prior lines of therapy |
| 2024-05-10 | Immix Biopharma, Inc. | Results Immix Biopharma Announces Positive NXC-201 Relapsed/Refractory AL Amyloidosis Clinical Data in ASGCT 2024 Late Breaking Oral Presentation immixbio.com ↗
1 patient with prior exposure to BCMA-targeted bispecific treatment did not respond |
| 2024-04-29 | Immix Biopharma, Inc. | Regulatory Immix Biopharma Awarded European Union Orphan Drug Designation for NXC-201 in Multiple Myeloma immixbio.com ↗
Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of multiple myeloma. |
| 2024-02-07 | Immix Biopharma, Inc. | Regulatory Immix Biopharma Awarded European Union Orphan Drug Designation for NXC-201 in AL Amyloidosis immixbio.com ↗
today announced that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of AL Amyloidosis. |
| 2023-12-11 | Nexcella Inc. | Results Nexcella Announces 100% Overall Response Rate (n=10); 23.7 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2023 nexcella.com ↗
100% (10/10) overall response rate (ORR) and 70% (7/10) complete response (CR) rate observed in standard of care (Dara-CyBorD) relapsed/refractory AL Amyloidosis patients with median 6 lines of prior therapy in updated Phase 1/2 data as of December 10, 2023 |
| 2023-12-11 | Immix Biopharma, Inc. | Results Immix Biopharma Announces 100% Overall Response Rate (n=10); 23.7 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2023 immixbio.com ↗
100% (10/10) overall response rate (ORR) and 70% (7/10) complete response (CR) rate observed in standard of care (Dara-CyBorD) relapsed/refractory AL Amyloidosis patients with median 6 lines of prior therapy in updated Phase 1/2 data as of December 10, 2023 |
| 2023-11-21 | Nexcella Inc. | Regulatory Nexcella Announces FDA Approval of IND Application for CAR-T NXC-201, Enabling U.S. Patient Dosing nexcella.com ↗
Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for BCMA CAR-T NXC-201 (formerly HBI0101). |
| 2023-11-21 | Immix Biopharma, Inc. | Regulatory Immix Biopharma Announces FDA Approval of IND Application for CAR-T NXC-201, Enabling U.S. Patient Dosing immixbio.com ↗
Immix Biopharma, Inc. (Nasdaq:IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company advancing personalized therapies for oncology and immunology, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for BCMA CAR-T NXC-201 (formerly HBI0101). |
| 2023-11-06 | Nexcella Inc. | Results Nexcella Presents NXC-201 Data at 65th American Society of Hematology (ASH) Annual Meeting in 9 Relapsed/Refractory AL Amyloidosis Patients nexcella.com ↗
100% overall response rate observed in relapsed/refractory AL Amyloidosis patients with median 6 lines of prior therapy |
| 2023-11-06 | Nexcella Inc. | Results Nexcella Presents NXC-201 Data at 65th American Society of Hematology (ASH) Annual Meeting in 63 Relapsed/Refractory Multiple Myeloma Patients nexcella.com ↗
95% overall response rate observed in relapsed/refractory multiple myeloma patients not previously treated with BCMA-targeted therapy |
| 2023-11-06 | Immix Biopharma, Inc. | Results Immix Biopharma Presents NXC-201 Data at 65th American Society of Hematology (ASH) Annual Meeting in 9 Relapsed/Refractory AL Amyloidosis Patients immixbio.com ↗
100% overall response rate observed in relapsed/refractory AL Amyloidosis patients with median 6 lines of prior therapy |
| 2023-11-06 | Immix Biopharma, Inc. | Results Immix Biopharma Presents NXC-201 Data at 65th American Society of Hematology (ASH) Annual Meeting in 63 Relapsed/Refractory Multiple Myeloma Patients immixbio.com ↗
95% overall response rate observed in relapsed/refractory multiple myeloma patients not previously treated with BCMA-targeted therapy |
| 2023-10-03 | Nexcella Inc. | Results Nexcella Announces Complete Response in 9th Relapsed/Refractory AL Amyloidosis Patient in NXC-201 Clinical Trial at IMS 20th Annual Meeting nexcella.com ↗
100% (9/9) overall response rate and 67% (6/9) complete response rate (MRD 10 -5 ) observed in heavily pre-treated patients with daratumumab relapsed/refractory AL Amyloidosis as of the September 20, 2023 data cutoff |
| 2023-10-03 | Immix Biopharma, Inc. | Results Immix Biopharma Announces Complete Response in 9th Relapsed/Refractory AL Amyloidosis Patient in NXC-201 Clinical Trial at IMS 20th Annual Meeting immixbio.com ↗
100% (9/9) overall response rate and 67% (6/9) complete response rate (MRD 10-5) observed in heavily pre-treated patients with daratumumab relapsed/refractory AL Amyloidosis as of the September 20, 2023 data cutoff |
| 2023-10-02 | Nexcella Inc. | Results Nexcella Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma nexcella.com ↗
95% overall response rate observed in relapsed/refractory multiple myeloma patients not previously treated with BCMA-targeted therapy. |
| 2023-10-02 | Immix Biopharma, Inc. | Results Immix Biopharma Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma immixbio.com ↗
Immix Biopharma Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”) today announced the presentation of updated data from the ongoing Phase 1b/2 NEXICART-1 (NCT04720313) study of its novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. |
| 2023-09-21 | Nexcella Inc. | Regulatory U.S. Food and Drug Administration Approves Orphan Drug Designation for Nexcella NXC-201 as a Treatment for Amyloid Light Chain (AL) Amyloidosis nexcella.com ↗
Nexcella, Inc. (“Nexcella” or the “Company”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) designation for NXC-201 for the treatment of a life-threatening blood disorder, Amyloid Light Chain (AL) Amyloidosis. |
| 2023-09-21 | Immix Biopharma, Inc. | Regulatory U.S. Food and Drug Administration Approves Orphan Drug Designation for Immix Biopharma NXC-201 as a Treatment for Amyloid Light Chain (AL) Amyloidosis immixbio.com ↗
Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio” or the “Company”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) designation for NXC-201 for the treatment of a life-threatening blood disorder, Amyloid Light Chain (AL) Amyloidosis. |
| 2023-08-23 | Nexcella Inc. | Regulatory U.S. Food and Drug Administration Approves Orphan Drug Designation for NXC-201 as a Treatment for Multiple Myeloma nexcella.com ↗
Nexcella, Inc. (“Nexcella” or the “Company”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) designation for NXC-201 for the treatment of a life-threatening form of blood cancer, multiple myeloma. |
| 2023-08-23 | Immix Biopharma, Inc. | Regulatory U.S. Food and Drug Administration Approves Orphan Drug Designation for Immix Biopharma NXC-201 as a Treatment for Multiple Myeloma immixbio.com ↗ |
| 2023-05-21 | Nexcella Inc. | Results Nexcella Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial nexcella.com ↗
Best responder duration of response was 16.5 months with response ongoing as of the data cutoff date of May 11, 2023 |
| 2023-05-21 | Immix Biopharma, Inc. | Results Immix Biopharma Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial immixbio.com ↗
100% (8/8) overall response rate and 63% (5/8) complete response (MRD 10-5) was demonstrated by NXC-201 with zero ICANs, zero grade 4 CRS |
| 2023-04-26 | Nexcella Inc. | Results Nexcella Announces Positive 58-Patient NXC- 201 Clinical Data: 100% Overall Response Rate in light chain (AL) Amyloidosis; 92% Overall Response Rate in Multiple Myeloma at the EBMT 49th Annual Meeting in Paris nexcella.com ↗
100% (8/8) was the overall response rate produced by NXC-201 in 8 light chain (AL) amyloidosis patients in our ongoing phase 1b/2a NEXICART-1 clinical trial (NCT04720313) |
| 2023-04-26 | Immix Biopharma, Inc. | Results Nexcella, an Immix Biopharma subsidiary, Announces Positive 58-Patient NXC-201 Clinical Data: 100% Overall Response Rate in Light Chain (AL) Amyloidosis; 92% Overall Response Rate in Multiple Myeloma at the EBMT 49th Annual Meeting in Paris immixbio.com ↗
100% (8/8) was the overall response rate produced by NXC-201 in 8 light chain (AL) amyloidosis patients in our ongoing phase 1b/2a NEXICART-1 clinical trial (NCT04720313) |
| 2023-03-31 | Nexcella Inc. | Results Nexcella Announces 2023 Haematologica Editorial Highlighting NXC-201 Efficacy In The Context of U.S. Food And Drug Administration Approved BCMA CAR T Cells nexcella.com ↗
[Furthermore, the NXC-201] trial included nine patients who had relapsed after treatment with an anti-BCMA antibody, belantamab mafodotin, prior to receiving HBI0101, which the authors suggested may be associated with a less favorable response to CAR therapy. |
| 2023-03-31 | Immix Biopharma, Inc. | Results Nexcella, an Immix Biopharma Subsidiary, Announces 2023 Haematologica Editorial Highlighting NXC-201 Efficacy In The Context of U.S. Food And Drug Administration Approved BCMA CAR T Cells immixbio.com ↗
To date, 58 patients have been treated with NXC-201, 50 in multiple myeloma, and 8 in AL amyloidosis. |
| 2023-03-23 | Nexcella Inc. | Results Nexcella Announces New Positive NXC-201 Clinical Data Demonstrating 100% Complete Responses in AL Amyloidosis Patients + Additional Positive Multiple Myeloma Safety Data Demonstrating NXC-201 Outpatient CAR-T Treatment Potential nexcella.com ↗
Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”) today announced that NXC-201 treatment continues to demonstrate 100% complete hematologic responses and 100% organ response rate – cardiac, renal, liver response – in a total of 8 AL amyloidosis patients (an additional 2 patients maintaining 100% complete response). |
| 2023-03-23 | Immix Biopharma, Inc. | Results Nexcella, an Immix Biopharma Subsidiary, Announces New Positive NXC-201 Clinical Data Demonstrating 100% Complete Responses in AL Amyloidosis Patients + Additional Positive Multiple Myeloma Safety Data Demonstrating NXC-201 Outpatient CAR-T Treatment Potential immixbio.com ↗
In AL Amyloidosis, our 100% complete response rate with 100% organ responses across cardiac, renal and liver organ systems fuels our continued excitement. |
| 2023-02-09 | Nexcella Inc. | Results Nexcella, Inc. Presents 42-Patient Interim Data, with 90% Overall Response Rate in Relapsed or Refractory Multiple Myeloma at NXC-201 Therapeutic Dose from its Phase 1 Expansion Trial at the 5th European CAR T-cell Meeting nexcella.com ↗
90% overall response rate (ORR) was observed in 29 multiple myeloma patients receiving the therapeutic dose of NXC-201 |
| 2023-02-09 | Immix Biopharma, Inc. | Results Immix Biopharma Subsidiary Nexcella, Inc. Presents 42-Patient Interim Data, with 90% Overall Response Rate in Relapsed or Refractory Multiple Myeloma at NXC-201 Therapeutic Dose from its Phase 1 Expansion Trial at the 5th European CAR T-cell Meeting immixbio.com ↗
90% overall response rate (ORR) was observed in 29 multiple myeloma patients receiving the therapeutic dose of NXC-201 |
| 2023-01-06 | Immix Biopharma, Inc. | Results Immix Biopharma Subsidiary Nexcella, Inc. Announces Additional Positive NXC-201 Clinical Data Demonstrating 100% Complete Responses in Relapsed/Refractory AL Amyloidosis Patients, Duration of Response Not Yet Reached immixbio.com ↗
Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”) today announced that NXC-201 treatment continues to demonstrate 100% complete responses in a total of 6 relapsed/refractory AL amyloidosis patients. |
All press releases naming this drug 85 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NXC-201 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07709715 ↗ |
| Known as | HBI0101 | “NXC-201 (formerly HBI0101) CART is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding the chimeric antigen receptor (CAR) targeted...” NCT04720313 ↗ |
| Modality | Cell therapy | “autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA.” NCT06097832 ↗ |