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Also known as NXC-201 (formerly HBI0101)
NXC-201 · 2 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 )
| 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 |
| 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. |
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 small molecule being studied for the treatment of light chain (AL) amyloidosis and multiple myeloma. It is currently in clinical development for dose escalation and safety evaluation, with a Phase 3 trial planned for newly diagnosed systemic AL amyloidosis.
NXC-201 is a small molecule therapeutic, but its specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated for its efficacy and safety in conditions such as AL amyloidosis and multiple myeloma.
NXC-201 is being developed by Immix Biopharma, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol IMMX. The company is advancing the drug through clinical trials for AL amyloidosis and related conditions.
NXC-201 is currently in Phase 1 clinical development, with an active trial for multiple myeloma. A Phase 3 trial for newly diagnosed systemic AL amyloidosis has been planned but has not yet started recruiting participants.
NXC-201 is involved in two clinical trials. The first, NCT04720313, is a Phase 1 study in multiple myeloma that is active but not recruiting. The second, NCT07709715, is a planned Phase 3 study in AL amyloidosis that has not yet begun enrollment.
Yes, NXC-201 was formerly known as HBI0101. The drug is being developed under the new name NXC-201 by Immix Biopharma, and clinical trial records may reference the earlier name HBI0101.