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NXC-201 CAR-T · 1 trial · 1 indication
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 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 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. |
Inclusion Criteria: 1. ≥18 years of age. 2. Voluntarily signed informed consent form (ICF). 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 4. Histologically proven systemic AL amyloidosis confirmed by positive Congo red staining with green birefringence on polarized light micr...
NXC-201 CAR-T is an investigational chimeric antigen receptor T-cell therapy being studied for the treatment of Light Chain (AL) Amyloidosis, a rare disease. It is currently in Phase 1 clinical development and has not been approved by the FDA.
NXC-201 CAR-T is a CAR-T cell therapy, but its specific molecular target has not been disclosed in the available information. It is being investigated for its potential to treat Light Chain (AL) Amyloidosis.
NXC-201 CAR-T is being developed by Immix Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IMMX. The company is conducting clinical trials to evaluate the therapy's safety and efficacy.
NXC-201 CAR-T is currently in Phase 1 clinical trials. It is an investigational therapy and has not received FDA approval. The drug has been granted Orphan Drug, Regenerative Medicine Advanced Therapy (RMAT), and Breakthrough Therapy designations by the FDA.
NXC-201 CAR-T is being evaluated in a Phase 1 clinical trial with the identifier NCT06097832. This study is active but not recruiting, with an estimated enrollment of 45 participants. The trial is being conducted in the United States and includes adults aged 18 years and older.
NXC-201 CAR-T is the same as NXC-201, as the CAR-T designation indicates it is a chimeric antigen receptor T-cell therapy. The drug is also referred to by the name NXC-201 in clinical trial registrations and company communications.