Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NXC-201 CAR-T, NXC-201 (formerly HBI0101)
NXC-201 · 3 trials · 2 indications
CHR rate is defined as percentage of participants who achieved CHR
MOD-PFS is defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurs first
Part A: Determination of MTD Part B: Confirmation of selected dose tested (at or below MTD) ( safety )
An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal. laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, with the exception of cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). CRS and ICANS should be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading.
According to Common Terminology Criteria for Adverse Events (CTCAE) criteria, version 5.0, and Cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS) per American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading
According to Common Terminology Criteria for Adverse Events (CTCAE) criteria, version 5.0, and Cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS) per American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading
| Arm | Type | Description |
|---|---|---|
| NXC-201 | EXPERIMENTAL | NXC-201 CAR-T |
| Daratumumab plus CyBorD | ACTIVE_COMPARATOR | Daratumumab plus CyBorD |
| CART BCMA | EXPERIMENTAL | The dose escalation phase (Part A) will include the following doses of CAR-positive (CAR+) T cells: 150×10\^6, 450×10\^6, 800×10\^6 or 1200 ×10\^6 The expansion phase (Part B) will include a dose between 450×10\^6 to 800×10\^6 CAR-positive (CAR+) T cells |
| NXC-201 CAR-T | EXPERIMENTAL | The dose escalation phase will include the following doses: Cohort 1 - 150×10\^6 CAR-positive (CAR+) T cells (3 patients) Cohort 2 - 450×10\^6 CAR-positive (CAR+) T cells (3 patients) The dose expansion phase will then proceed. |
| Name | Type | Description |
|---|---|---|
| NXC-201 | BIOLOGICAL | NXC-201 CAR-T is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding a proprietary chimeric antigen receptor (CAR) targeted to human BCMA. |
| Dara-CyBorD | DRUG | Daratumumab plus CyBorD combination |
| NXC-201 (formerly HBI0101) | DRUG | 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 to human BCMA. The NXC-201 (formerly HBI0101) CART is provided fresh without cryopreservation. |
| NXC-201 CAR-T | BIOLOGICAL | NXC-201 (formerly HBI0101) CAR-T is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA. The NXC-201 CAR-T is provided fresh without cryopreservation. |
Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group performance status score ≤2 2. Newly diagnosed AL Amyloidosis per consensus criteria as defined in the protocol 3. Measurable disease as defined in the protocol 4. One or more organs impacted by AL amyloidosis Key Exclusion Criteria: 1...
NXC-201 is an investigational BCMA-targeted CAR-T cell therapy being developed by Immix Biopharma, Inc. for light chain (AL) amyloidosis. It is also known as NXC-201 CAR-T and was formerly called HBI0101. It is in clinical development and has received Orphan Drug designation from the FDA.
NXC-201 is being studied for the treatment of light chain (AL) amyloidosis, a condition in which abnormal antibody light chains deposit in organs. Clinical development includes a Phase 1 study in AL amyloidosis and a planned Phase 3 study in newly diagnosed systemic AL amyloidosis.
NXC-201 targets BCMA, or B-cell maturation antigen, which is expressed on plasma cells. By targeting BCMA, the CAR-T therapy is designed to act on the plasma cells that produce the abnormal light chains underlying AL amyloidosis.
NXC-201 is being developed by Immix Biopharma, Inc., which trades under the ticker IMMX. The company is advancing the BCMA-targeted CAR-T therapy in light chain (AL) amyloidosis.
NXC-201 is in Phase 1 clinical development for AL amyloidosis, with a Phase 3 study planned. It is investigational and has not been approved by the FDA. The FDA has granted Orphan Drug designation to NXC-201.
NXC-201 is being evaluated in NCT06097832, an active Phase 1 study of NXC-201 CAR-T in patients with light chain (AL) amyloidosis in the United States, and in NCT07709715, a Phase 3 study in newly diagnosed systemic AL amyloidosis that is not yet recruiting. A Phase 1 multiple myeloma study, NCT04720313, has also been conducted.
Yes. NXC-201 was formerly known as HBI0101, and it is also referred to as NXC-201 CAR-T. These names refer to the same BCMA-targeted CAR-T cell therapy developed by Immix Biopharma for light chain (AL) amyloidosis.