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Also known as Azercabtagene zapreleucel (azer-cel)
Azercabtagene zapreleucel · 1 trial · 1 indication
DLT will be determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
| Arm | Type | Description |
|---|---|---|
| Azer-cel | EXPERIMENTAL | Participants will receive a single dose of intravenous (IV) infusion of azer-cel at different dose levels, on Day 0 of the treatment period. |
| Name | Type | Description |
|---|---|---|
| Azercabtagene zapreleucel (azer-cel) | DRUG | IV infusion |
Inclusion Criteria: PMS and RMS inclusion criteria: 1. Age 18 years to ≤60 years (inclusive) at screening. 2. Expanded Disability Status Scale (EDSS) score 3.0 - 6.5 (inclusive) at screening. 3. Diagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (n...
Azercabtagene zapreleucel is an investigational CAR-T cell therapy being developed for B-cell mediated autoimmune disorders. It is in Phase 1 clinical development and is also known as azer-cel. It is not yet approved for any indication.
Azercabtagene zapreleucel is being studied for the treatment of B-cell mediated autoimmune disorders. It is an investigational therapy in Phase 1 development and has not been approved for commercial use in this or any other indication.
Azercabtagene zapreleucel targets CD19, a protein found on the surface of B cells. By targeting CD19, the CAR-T therapy is designed to act on B cells involved in autoimmune disease. It belongs to the cell therapy class.
Azercabtagene zapreleucel is being developed by TG Therapeutics, Inc., which trades under the ticker TGTX. The company is running the clinical program for this CAR-T candidate in B-cell mediated autoimmune disorders.
Azercabtagene zapreleucel is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 1 program is currently recruiting participants.
Azercabtagene zapreleucel is being evaluated in one active clinical trial, NCT06680037, titled A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders. The Phase 1 trial is recruiting up to 100 participants in the United States.
Yes, azer-cel is the short name for azercabtagene zapreleucel. Both names refer to the same investigational CD19-directed CAR-T cell therapy being developed by TG Therapeutics for B-cell mediated autoimmune disorders.