FDA Grants Fast Track Designation for KB-GDT-01 to Treat Patients with Non-Small Cell Lung Cancer

KB-GDT-01 (Deltacel; Kiromic BioPharma, Inc) in combination with low-dose radiation therapy receives fast track designation from the FDA for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on at least 2 prior lines of standard-of-care treatment, including platinum-based chemotherapy, immune checkpoint inhibitors and targeted therapy. The designation follows statistically significant interim safety and efficacy data from part 1 of the Deltacel-01 clinical trial (NCT06069570).¹

In the long-term follow-up, data showed an average PFS of 4.8 months among 5 participants. Image Credit: © Chinnapong - stock.adobe.com

KB-GDT-01 is an allogeneic, investigational delta T cell (GDT) therapy consisting of unmodified, donor-derived gamma delta T cells. It is designed to target solid tumors using the natural potency of GDT cells. KB-GDT-01 is being evaluated for treatment of patients with stage 4 NSCLC who did not respond to standard therapies. The primary end point for the trial is safety with additional secondary measurements including objective response, progression-free survival (PFS), overall survival, time to progression, time to treatment response, and disease control rates.^2-4

Patients qualified for enrollment must be at least 18 years of age with stage 4 NSCLC and at least 1 measurable target lesion. Additionally, they need to have a ECOG performance status of 0 or 1 and have progressed on 2 or more prior lines of standard of care therapy. Any toxicities associated with prior lines of treatment must be recovered to grade 1 or lower, excluding continuing alopecia. Patients must also have a life expectancy of at least 6 months and adequate hepatic, renal, and hematopoietic function.^2-4

In the open-label trial, patients with stage 4 NSCLC are to receive 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. In the long-term follow-up, data showed an average PFS of 4.8 months among 5 participants. The researchers reported patients who completed the full treatment had no dose-limiting toxicities. Of the trial population, 1 patient withdrew prior to completing treatment due to instance of an adverse event related to a pre-existing comorbidity. A final sixth patient began treatment on August 6, 2024.^2-4

“We are encouraged by the FDA’s recognition of our innovative approach and are committed to the clinical development of [KB-GDT-01],” Pietro Bersani, chief executive officer of Kiromic BioPharma, said in a press release. “Fast Track designation will enable us to work more closely with the FDA as we complete [KB-GDT-01] and advance this promising therapy into later stage studies.”⁴

REFERENCES

1. Safety study for a gamma delta t cell product used with low dose radiotherapy in patients with stage 4 metastatic nsclc. Clinicaltrials.gov identifier NCT06069570. Updated December 15, 2023. Accessed August 15, 2024. https://www.clinicaltrials.gov/study/NCT06069570?cond=nsclc&term=kiromic&rank=1#more-information
2. Deltacel Plus Radiation Wins FDA Fast Track Designation for Pretreated Metastatic NSCLC. OncLive. August 14, 2024. Accessed August 15, 2024. https://www.onclive.com/view/deltacel-plus-radiation-wins-fda-fast-track-designation-for-pretreated-metastatic-nsclc 
3. T-Cell Therapy Deltacel Elicits Early Safety and Efficacy in NSCLC. OncLive. August 9, 2024. Accessed August 15, 2024. https://www.onclive.com/view/t-cell-therapy-deltacel-elicits-early-safety-and-efficacy-in-nsclc
4. Kiromic BioPharma’s Deltacel Receives FDA Fast Track Designation. I. August 14, 2024. Accessed August 15, 2024. https://www.businesswire.com/news/home/20240814382482/en