Kiromic BioPharma, Inc. announced that the first patient has initiated treatment at the Beverly Hills Cancer Center (BHCC) in the Company?s Deltacel-01 clinical trial. This Phase 1 study is evaluating Deltacel? for the treatment of stage 4 metastatic non-small cell lung cancer (NSCLC).

Initial tolerability and safety data from this first patient is expected to be available by year-end. Additionally, Kiromic expects to report preliminary efficacy results from the first patient by the end of January 2024. The Company expects that the Deltacel-01 clinical trial will start enrolling patients at two additional clinical sites in early 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.