Allogeneic T-Cell Therapy Produces Efficacy at 10 Months in Stage IV Metastatic NSCLC

The investigational allogeneic gamma delta T-cell (GDT) therapy Deltacel (KB-GDT-01) demonstrated favorable safety and initial efficacy signals after 10 months of follow-up for the first patient with stage IV metastatic non–small cell lung cancer (NSCLC) treated in the phase 1/2 Deltacel-01 trial (NCT06069570), according to an announcement from Kiromic BioPharma.¹

This patient achieved an approximate 27% reduction in tumor size from baseline at 10 months; previously, approximate 20% and 13% reductions in tumor size had been detected 8 and 6 months after treatment, respectively. No new lesions were identified. Accordingly, the progression-free survival (PFS) reached 10 months with no adverse effects (AEs) observed.

Interim data from 5 evaluable patients in long-term follow-up from the study were previously reported. Among these patients, the average PFS was 4.8 months (range, 2-8). No dose-limiting toxicities were observed among the patients who received the full course of Deltacel. Notably, 1 patient withdrew from the study due to an AE associated with a pre-existing comorbidity prior to completion of all doses; this AE was related to Deltacel, and the patient was not evaluated for PFS.²

Additional follow-up data from the fourth patient enrolled onto the study are expected to read out in October 2024.¹

“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,” Pietro Bersani, chief executive officer of Kiromic BioPharma, stated in a news release. “We believe these findings underscore the promise of our allogeneic GDT therapy in providing durable clinical benefit.”

Deltacel is an allogeneic product that leverages unmodified, donor-derived GDTs to target solid tumors without the need for viral vectors. Deltacel is designed to harness the inherent antitumor potency of these cells, with an initial focus on NSCLC. Preclinical research has indicated that Deltacel has a favorable safety and efficacy profile when administered in combination with low-dose radiation.

“The latest results from this patient are highly promising, particularly given the durable PFS and tumor reduction we observed,” Afshin Eli Gabayan, MD, a medical oncologist, medical director, and principal investigator of the Deltacel-01 study at Beverly Hills Cancer Center in California, added. “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 Overview

Deltacel-01 trial is an open-label, 2-part trial evaluating Deltacel in patients at least 18 years of age with histologically or cytologically confirmed stage IV metastatic NSCLC who have progressed on at least 2 lines of standard therapy, including platinum-based chemotherapy and immune checkpoint inhibitors. An ECOG performance status of 0 or 1, at least 1 measurable target lesion per RECIST 1.1 criteria, and prior progression on appropriate target-directed molecular therapy if harboring known actionable mutations are also required.³

In the dose-escalation phase, patients receive 2 intravenous doses of Deltacel at either 400 x 10⁶, 800 x 10⁶, or 1600 x 10⁶ cells alongside 4 courses of low-dose, localized radiotherapy at 1.0 Gy per fraction over 10 days.

Safety serves as the trial’s primary end point. Key secondary end points include objective response rate, PFS, overall survival, time to progression, time to treatment response, and disease control rate. The study plans to enroll 36 patients onto part 1 and up to 12 additional patients onto part 2.

The study is being conducted across 5 locations, 4 of which are active. These include Beverly Hills Cancer Center; Virginia Oncology Associates in Norfolk; the University of Pittsburgh School of Medicine in Pennsylvania; and Texas Oncology in Tyler. The study is expected to be completed in January 2027.

References

1. Kiromic BioPharma reports favorable 10-month follow-up results for the first patient treated in its Deltacel-01 clinical trial. News Release. Kiromic Biopharma, Inc. October 1, 2024. Accessed October 1, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-reports-favorable-10-month-follow-results
2. Kiromic Biopharma provides update on part 1 of the Deltacel-01 trial. News release. Kiromic BioPharma, Inc. August 9, 2024. Accessed October 1 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-provides-update-part-1-deltacel-01-trial
3. Safety study for a gamma delta T cell product used with low dose radiotherapy in patients with stage 4 metastatic NSCLC. ClinicalTrials.gov. Updated August 21, 2024. Accessed October 1, 2024. https://clinicaltrials.gov/study/NCT06069570