Kiromic BioPharma announced positive efficacy results from its Deltacel-01 Phase 1 clinical trial of Deltacel™, an allogeneic, off-the-shelf Gamma Delta T-cell therapy for late-stage non-small cell lung cancer (NSCLC). Two patients showed significant tumor reduction: the first enrolled patient experienced a 33.33% reduction at the 12-month follow-up, and the seventh patient showed a 9.5% reduction at the two-month mark. Both patients are being treated at the Beverly Hills Cancer Center. Additionally, the eighth patient completed treatment and awaits efficacy results, while the ninth recently began treatment at a different location.
These results are promising for patients with advanced NSCLC who have limited treatment options after failing standard therapies. The sustained tumor reduction observed in the initial patient, coupled with the responses seen in subsequent patients, suggests Deltacel™ may offer a new therapeutic avenue. This strengthens the potential for gamma delta T-cell therapies to address this challenging cancer.
The Deltacel-01 trial is an open-label Phase 1 study evaluating Deltacel™ in combination with low-dose radiation. The primary objective is safety, with secondary endpoints including objective response, progression-free survival, and overall survival. The company is continuing to expand enrollment with the tenth and eleventh patients expected to join by the end of January. The eighth patient’s initial efficacy results are anticipated in late February 2025.
These ongoing results could significantly impact the development of GDT cell therapies and provide a potential new treatment option for advanced NSCLC. The continued enrollment and upcoming efficacy data will be crucial for further validating Deltacel™’s efficacy and safety profile, paving the way for potential future trials and ultimately, impacting the treatment landscape for this patient population.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
