On May 20, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported that UPMC in Pittsburgh, Pennsylvania has been activated as the fourth clinical trial site in the Deltacel-01 Phase 1 trial evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) (Press release, Kiromic, MAY 20, 2024, View Source [SID1234643457]).
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UPMC is a world-renowned healthcare system that employs some of the nation’s top clinicians and medical researchers. UPMC Hillman Cancer Center is Western Pennsylvania’s only National Cancer Institute-designated Comprehensive Cancer Center.
The lead principal investigator for Deltacel-01, Jason J. Luke, MD, FACP, will also serve as principal investigator at the UPMC site. Dr. Luke is Associate Professor of Medicine at the University of Pittsburgh and UPMC Hillman Cancer Center, where he is Associate Director for Clinical Research and Director of the Immunotherapy and Drug Development Center.
"We’re delighted to have Dr. Jason Luke and UPMC participating in the conduct of research of our potentially transformative therapy. Dr. Luke is one of the world’s foremost investigators in immuno-oncology, having led clinical trials of immunotherapies across many cancer types. His expertise in early phase drug development for solid tumors has played a critical role in shaping our trial, and we are optimistic Deltacel will demonstrate continued favorable outcomes in this deadly disease as we expand treatment to patients across more sites. We expect to activate one more clinical trial site later this quarter and to begin enrolling patients at UPMC this summer," said Pietro Bersani, Chief Executive Officer of Kiromic.
Kiromic also announces favorable preliminary safety and tolerability data from the fourth patient in Deltacel-01, with early efficacy data on this patient expected by the end of May. The fifth and sixth patients are expected to be enrolled later in May and June, respectively.
About Deltacel-01
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 Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.
About Deltacel
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 stage 4 metastatic 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 clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.