KIROMIC BIOPHARMA, INC. Kiromic BioPharma, Inc. reported favorable safety and tolerability from the first patient 23 days after Deltacel? infusion in the Phase 1 clinical trial for treatment of stage 4 metastatic non-small cell lung cancer (NSCLC) at Beverly Hills Cancer Center, located in Beverly Hills, California, USA. Specifically, laboratory test results and observations by clinical staff identified no adverse events and confirmed that Deltacel is being well tolerated with initial safety profile.
Continued monitoring of safety and tolerability will provide more insights as the trial enrolls additional patients. Kiromic expects to report preliminary efficacy results from this patient by the end of January 2024. Two more patients are expected to be enrolled between January and February 2024.
In Kiromic?s open-label Phase 1 clinical trial, titled ?Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer? (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the study is to evaluate safety, while secondary ones include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.
Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic?s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial focus on NSCLC, the most prevalent type of lung cancer and representing about 80% to 85% of lung cancer cases.
Data from two preclinical studies demonstrated Deltacel?s favorable safety and efficacy profile when it was combined with low-dose radiation.
