Kiromic BioPharma's investigational allogeneic gamma delta T-cell (GDT) therapy, Deltacel (KB-GDT-01), has shown encouraging initial efficacy and safety signals in a patient with stage IV metastatic non-small cell lung cancer (NSCLC) after 10 months of follow-up in the phase 1/2 Deltacel-01 trial (NCT06069570). The data suggests a potential new approach for patients with limited treatment options.
Durable Response Observed
The first patient treated in the Deltacel-01 trial experienced an approximate 27% reduction in tumor size from baseline at 10 months. Earlier assessments showed tumor size reductions of approximately 20% and 13% at 8 and 6 months post-treatment, respectively. Importantly, no new lesions were identified during the 10-month period. The patient achieved a progression-free survival (PFS) of 10 months, with no adverse effects (AEs) reported.
Interim Data from Deltacel-01 Trial
Previously reported interim data from five evaluable patients in long-term follow-up showed an average PFS of 4.8 months (range, 2-8 months). No dose-limiting toxicities were observed in patients who completed the full Deltacel treatment course. One patient withdrew from the study due to an AE linked to a pre-existing comorbidity before completing all doses; this AE was deemed unrelated to Deltacel, and the patient was not evaluated for PFS.
Management Perspective
Pietro Bersani, chief executive officer of Kiromic BioPharma, stated, "As this patient is the most advanced in our ongoing Deltacel-01 clinical trial, we are particularly encouraged by these latest follow-up results that continue to validate the potential of Deltacel as a safe and effective treatment for patients with later-stage cancers. We believe these findings underscore the promise of our allogeneic GDT therapy in providing durable clinical benefit."
About Deltacel
Deltacel is an allogeneic product utilizing unmodified, donor-derived GDTs to target solid tumors without viral vectors. It is designed to leverage the inherent antitumor potency of these cells, initially focusing on NSCLC. Preclinical studies suggest that Deltacel has a favorable safety and efficacy profile when combined with low-dose radiation.
Investigator Commentary
Afshin Eli Gabayan, MD, medical oncologist, medical director, and principal investigator of the Deltacel-01 study at Beverly Hills Cancer Center, commented, "The latest results from this patient are highly promising, particularly given the durable PFS and tumor reduction we observed. This patient’s response to GDT treatment continues to provide optimism as we evaluate Deltacel’s therapeutic potential. Continued meaningful results could represent a significant breakthrough for these [patients with] late-stage cancer with limited treatment options."
Deltacel-01 Trial Details
The Deltacel-01 trial is an open-label, two-part study assessing Deltacel in patients aged 18 years and older with histologically or cytologically confirmed stage IV metastatic NSCLC who have progressed on at least two lines of standard therapy, including platinum-based chemotherapy and immune checkpoint inhibitors. Key inclusion criteria include an ECOG performance status of 0 or 1, at least one measurable target lesion per RECIST 1.1 criteria, and prior progression on appropriate target-directed molecular therapy if harboring known actionable mutations.
During the dose-escalation phase, patients receive two intravenous doses of Deltacel at either 400 x 106, 800 x 106, or 1600 x 106 cells, along with four courses of low-dose, localized radiotherapy at 1.0 Gy per fraction over 10 days.
The primary endpoint of the trial is safety. Secondary endpoints include objective response rate, PFS, overall survival, time to progression, time to treatment response, and disease control rate. The study aims to enroll 36 patients in part 1 and up to 12 additional patients in part 2. The study is being conducted across five locations and is expected to be completed in January 2027. Additional follow-up data from the fourth patient enrolled onto the study are expected in October 2024.
