Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib, Pembrolizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | - | Undisclosed |
GCC2005 is an investigational small molecule being developed for the treatment of relapsed or refractory T-cell lymphoma. It is currently being studied in a Phase 1 clinical trial in patients with NK and T-cell malignancies, including T-cell lymphoma.
GCC2005 is being developed by Artiva Biotherapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ARTV.
GCC2005 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to evaluate its safety, tolerability, and efficacy.
GCC2005 is being studied in a single Phase 1 clinical trial with the identifier NCT06699771. This trial is investigating the safety, tolerability, and efficacy of GCC2005 in patients with relapsed or refractory NK and T-cell malignancies, including T-cell lymphoma. The trial is currently recruiting participants in South Korea.
Yes, GCC2005 is a small molecule drug. It is being developed as an oral or injectable therapeutic for the treatment of T-cell lymphoma, and it is currently in Phase 1 clinical testing.