Kiromic BioPharma Expands Deltacel-01 Trial for NSCLC to University of Arizona Cancer Center
核心洞察
Kiromic BioPharma (搜索) has activated the University of Arizona Cancer Center as the fifth clinical trial site for its Deltacel-01 Phase 1 trial.
The trial evaluates Deltacel™ (搜索) (KB-GDT-01), an allogeneic gamma delta T-cell (搜索) therapy, in patients with stage 4 metastatic non-small cell lung cancer (搜索) (NSCLC (搜索)).
The primary objective is to assess safety, with secondary endpoints including objective response and overall survival in patients who have failed standard therapies.
Kiromic BioPharma (搜索), Inc. has announced the activation of the University of Arizona Cancer Center (UACC) as the fifth clinical trial site for the ongoing Deltacel-01 Phase 1 trial. This trial is evaluating Deltacel™ (搜索) (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (搜索) (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (搜索) (NSCLC (搜索)) who have not responded to standard treatments. The UACC is one of the 57 NCI-Designated Comprehensive Cancer Centers in the U.S.
Dr. Ricklie Ann Julian, Assistant Professor of Medicine at UACC, will serve as the Principal Investigator at the site. Patient enrollment is expected to begin in the coming weeks.
Deltacel-01 Trial Details
The Deltacel-01 trial (NCT06069570) is an open-label Phase 1 study designed to evaluate the safety and tolerability of Gamma Delta T cell infusions in combination with low-dose radiotherapy in subjects with stage 4 metastatic NSCLC (搜索). Patients will receive two intravenous infusions of Deltacel™ (搜索) along with four courses of low-dose, localized radiation over a 10-day period.
The primary objective of the trial is to assess the safety of Deltacel™ (搜索). Secondary endpoints include objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.
About Deltacel™
Deltacel™ (搜索) (KB-GDT-01) is an investigational gamma delta T-cell (搜索) (GDT) therapy currently in Phase 1 clinical trials for stage 4 metastatic NSCLC (搜索). This allogeneic product consists of unmodified, donor-derived gamma delta T cells and is designed to target solid cancers. NSCLC accounts for approximately 80% to 85% of all lung cancer cases. Preclinical data has indicated a favorable safety and efficacy profile when Deltacel™ is combined with low-dose radiation.
Kiromic BioPharma's Approach
Kiromic BioPharma (搜索), Inc. is a clinical-stage biotherapeutics company utilizing its DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies focused on immuno-oncology. The company is developing an allogeneic cell therapy platform that leverages the natural capabilities of Gamma Delta T-cells to target solid tumors.