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GCC2005 · 1 trial · 1 indication
To evaluate the safety and tolerability of GCC2005 in patients with relapsed/refractory NK/T cell malignancies. Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs. Dose-limiting toxicities (DLTs)
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs. Dose-limiting toxicities (DLTs)
| Arm | Type | Description |
|---|---|---|
| Phase 1a Dose-Escalation and Phase 1b Dose and Regimen Optimization and Exploratory Expansion | EXPERIMENTAL | Phase 1a Multiple-Dose Cohort and Phase 1b Single-Dose Cohort |
| Name | Type | Description |
|---|---|---|
| GCC2005 | DRUG | CAR-NK Cell Therapy |
| Cyclophosphamide | DRUG | Lymphodepleting chemotherapy |
| Fludarabine | DRUG | Lymphodepleting chemotherapy |
Inclusion Criteria: * Participants with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017). * Participants with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any treatment optio...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib |
GCC2005 is an investigational therapy being studied for the treatment of relapsed or refractory T-cell lymphoma, including NK and T-cell malignancies. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
GCC2005 targets CD5, a protein expressed on certain immune cells. By targeting CD5, the drug is designed to address malignant T-cells in conditions like T-cell lymphoma. This mechanism is being evaluated in early-stage clinical trials for safety and efficacy.
GCC2005 is being developed by Artiva Biotherapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ARTV. The company is conducting clinical research to evaluate the drug's potential in treating T-cell malignancies.
GCC2005 is in Phase 1 clinical development. This early-stage trial is designed to investigate the safety, tolerability, and efficacy of the drug in patients with relapsed or refractory NK and T-cell malignancies. It is not yet approved for commercial use.
GCC2005 is being studied in a Phase 1 clinical trial registered as NCT06699771. This open-label, uncontrolled study is recruiting participants in South Korea and aims to enroll approximately 53 patients with T-cell lymphoma and related malignancies. The trial is currently active and recruiting.