No AEs 23 Days Out for First Patient With NSCLC Receiving Deltacel

Deltacel (KB-GDT-01; Kiromic Biopharma) γδ T-cell therapy has been well-tolerated in the first patient with metastatic non-small cell lung cancer (NSCLC) treated in the phase 1/2 Deltacel-01 clinical trial (NCT06069570).¹

The patient has experienced no adverse events (AEs) so far with 23 days of follow-up. The first patient was dosed in December 2023.² Kiromic expects to report preliminary efficacy results from this patient by the end of January 2024 and expects to enroll 2 more patients between January and February 2024.¹

"We are excited about the potential of this novel Gamma Delta T-cell therapy combined with low dose radiation for our patients with lung cancer who have few treatment options left,” Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at Beverly Hills Cancer Center, said in a statement when Kiromis announced the first dosing of a patient.² “Our clinical research team will continue monitoring this patient closely as we seek to understand how this innovative and exciting dual approach may impact the immune response against the cancer cells. We are hopeful that this investigational treatment approach can make a meaningful difference for lung cancer patients."

The Deltacel-01 trial is enrolling patients with stage 4 NSCLC to assess the safety, tolerability, and efficacy of Deltacel. The trial consists of a dose escalation portion that seeks to identify the best dose and assess AEs and preliminary efficacy in up to 36 participants. The second, dose-expansion portion will seek to further investigate the selected dose for safety and secondary endpoints including objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rate in up to 12 additional participants.

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Participants will receive 2 intravenous infusions of Deltacel in combination with 4 courses of low-dose, localized radiation over a 10-day period, followed by a 30-day short-term follow up period and a long-term follow-up period up to month 24.

"We are very pleased to see favorable initial safety and tolerability data from the first patient treated in our Deltacel-01 study," Gabayan said in a newer statement.¹ “Seeing no AEs reported 23 days after Deltacel infusion provides early validation that this novel cell therapy is well tolerated when combined with low dose radiation for lung cancer patients. We look forward to further evaluating optimal dose level, efficacy, and long-term safety outcomes as additional patients are enrolled and treated. If this promising initial data is replicated in more patients, Deltacel could become a new alternative treatment option for NSCLC patients.”

Deltacel is an investigational γδ T-cell therapy that consists of unmodified, donor-derived gamma delta T cells, and is Kiromic’s lead candidate using the company’s γδ platform. Deltacel has demonstrated favorable safety and efficacy when combined with low-dose radiation in 2 preclinical studies.

“Our first-in-human clinical trial of Deltacel is proceeding very well and on plan,” Pietro Bersani, Chief Executive Officer, Kiromic, added.¹ “With no AEs observed during the first 23 days post-treatment, we have strong indication that Deltacel is well tolerated.”

REFERENCES

1. Kiromic Biopharma reports favorable early safety and tolerability data from first patient enrolled in the phase 1 Deltacel-01 clinical trial. News release. Kiromic Biopharma. January 5, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-reports-favorable-early-safety-and
2. Kiromic BioPharma announces first patient dosed in phase 1 study evaluating Deltacel™ for the treatment of non-small cell lung cancer. News release. December 14, 2023. https://firstwordpharma.com/story/5810279?from=article