Artiva Biotherapeutics, Inc. ((ARTV)) announced an update on their ongoing clinical study.
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Study Overview: The clinical study titled A Phase 1, Multicenter Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of GCC2005 With Lymphodepleting Chemotherapy in Treatment of Patients With Relapsed or Refractory NK and T-cell Malignancies aims to evaluate the safety, tolerability, and preliminary efficacy of GCC2005 in patients with relapsed or refractory NK and T-cell malignancies. This study is significant as it targets patients who have undergone at least two prior lines of therapy, offering a potential new treatment avenue.
Intervention/Treatment: The study tests GCC2005, a CAR-NK cell therapy, alongside lymphodepleting chemotherapies Cyclophosphamide and Fludarabine. These interventions aim to treat relapsed or refractory NK and T-cell malignancies by enhancing immune response.
Study Design: This is an interventional, single-arm, open-label study with a sequential intervention model. It involves a dose-escalation phase (Phase 1a) to determine the dose-limiting toxicity (DLT) and a dose-expansion phase (Phase 1b) to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The primary purpose is treatment, with no masking involved.
Study Timeline: The study began on November 19, 2024, with the latest update submitted on April 28, 2025. These dates mark the study’s ongoing progress and the most recent information available, indicating active recruitment and data collection phases.
Market Implications: The update on this study could positively influence Artiva Biotherapeutics, Inc.’s stock performance by showcasing their involvement in innovative cancer therapies. As the study progresses, positive results may boost investor confidence and position the company favorably against competitors in the oncology sector.
The study is currently ongoing, with further details available on the ClinicalTrials portal.