T-Cell Therapy Deltacel Elicits Early Safety and Efficacy in NSCLC

Deltacel (KB-GDT-01), an off-the-shelf, Gamma Delta T-cell (GDT) therapy, generated early signals of clinical efficacy and a tolerable safety profile in patients with stage IV metastatic non–small cell lung cancer (NSCLC) who have not responded to standard therapies, according to interim findings from part 1 of the phase 1 Deltacel-01 trial (NCT06069570).¹

In the long-term follow-up, among 5 patients evaluated for progression-free survival (PFS), the average PFS was 4.8 months (range, 2-8). The clinical trial site has reported no dose-limiting toxicities among patients who have completed the full course of therapy. One patient was withdrawn from the trial before completing the full course of therapy because of an adverse effect that was deemed related to a pre-existing comorbidity and not related to Deltacel. As such, this patient was not evaluable for PFS. The sixth patient, who is the last to be enrolled in part 1 of the trial, initiated treatment on August 6, 2024.

“We are pleased to have completed enrollment in part 1 of our clinical trial,” Pietro Bersani, chief executive officer of Kiromic BioPharma, stated in a news release. “The favorable results of our GDT therapy, particularly with respect to PFS, in the first 2 cohorts that comprise part 1 underscore the potential of Deltacel to treat [patients with] solid tumors, and we look forward to launching part 2 of this study.”

Deltacel is an allogeneic GDT product that consists of unmodified, donor-derived gamma delta T cells. The therapy is designed to use the natural potency of GDT cells to target solid tumors.

Previously, a preclinical study demonstrated favorable safety findings with Deltacel alone and in combination with a nonbiological antitumor therapy in mice.² The histopathology report by a certified veterinary pathologist, showed no adverse microscopic findings related to Deltacel administration alone or as part of combination therapy.

Other preclinical studies have shown a favorable safety and efficacy profile with Deltacel combined with low-dose radiation.¹

The open-label Deltacel-01 trial is enrolling patients at least 18 years of age with histologically or cytologically confirmed stage IV metastatic NSCLC and at least 1 measurable target lesion per RECIST v1.1 criteria.³ Patients need to have an ECOG performance status of 0 or 1 and have progressed on at least 2 prior lines of standard therapy, including immune checkpoint inhibitors and platinum-based therapy. Patients with tumors harboring known actionable molecular alterations must have progressed on appropriate targeted molecular therapy. All toxicity associated with prior treatments must be recovered to grade 1 or lower, except for continuing alopecia. Patients must also have a life expectancy of at least 6 months, as well as adequate hepatic, renal, and hematopoietic function.

Patients will receive 4 courses of low-dose, localized radiation at 1.0 Gy per fraction on days 1 and 2, followed by the first intravenous infusion of Deltacel at 400 x 10⁶, 800 x 10⁶, or 1600 x 10⁶ cells on day 3. Radiation will be repeated on days 8 and 9, and the second Deltacel infusion will occur on day 10.

The trial’s primary end point is safety. Secondary end points include objective response rate, PFS, overall survival, time to progression, time to treatment response, and disease control rate.

Kiromic expects to receive early safety and tolerability results from the last enrolled patient in September 2024 and expects to receive efficacy results in October 2024.¹ The company plans to begin part 2 of Deltacel-01 in September 2024.

References

1. Kiromic BioPharma provides update on part 1 of the Deltacel-01 trial. News release. Kiromic BioPharma, Inc. August 9, 2024. Accessed August 9, 2024. https://www.businesswire.com/news/home/20240809927283/en
2. Kiromic BioPharma reports favorable Deltacel preclinical pharmacology results. News release. Kiromic BioPharma, Inc. February 28. 2023. Accessed August 9, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-reports-favorable-deltaceltm-preclinical
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 December 15, 2023. Accessed August 9, 2024. https://www.clinicaltrials.gov/study/NCT06069570?cond=nsclc&term=kiromic&rank=1