NeoImmuneTech Announces FDA IND Submission by Investigator for Repeat-Dosing Trial of NT-I7 post CAR-T Therapy

NT-I7 aims to maximize treatment response through an early and repeated dosing strategy; the trial is led by Dr. John Dipersio at Washington University School of Medicine Follow-up trial expected to accelerate the path toward commercialization and add momentum to licensing discussions July 14, 2025 — ROCKVILLE, MD : NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a T cell-focused immunotherapy company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by Investigator for a follow-up clinical trial investigating the combination of its T cell amplifier NT-I7 (efineptakin alfa) with CAR-T therapy. The clinical trial is an Investigator-Initiated Trial (IIT) led by Dr. John DiPersio, Virginia E. and Sam J. Golman Professor in Medicine and Director of the Center for Gene and Cellular Immunotherapy at Washington University School of Medicine in St. Louis. It is a continuation of the previously conducted NIT-112 study, which evaluated the single-dose combination of NT-I7 and CAR-T therapy. Planned at the request of Dr. DiPersio, the upcoming trial will evaluate a two-dose strategy of NT-I7 in patients with large B-cell lymphoma (LBCL) who have received either Yescarta (Axi-cel) or Breyanzi (Liso-cel). Under this protocol, NT-I7 will be administered on Days 10 and 31 following CAR-T infusion. The study is designed as a Phase 1b trial to assess additional safety related to the modified dosing schedule, with NT-I7 administered at doses of 600μg/kg and 720μg/kg to up to six patients per cohort (n=3+3). NeoImmuneTech is also exploring the possibility of transitioning this study into a Phase 2 trial. Although the safety of NT-I7 was previously demonstrated in the NIT-112 study, the modified dosing strategy warrants further safety evaluation; therefore, the current trial has been designed as a Phase 1b study. Upon confirmation of safety, the company plans to promptly initiate a Phase 2 trial to enroll additional patients and evaluate efficacy. NeoImmuneTech is strategically leveraging this Investigator-Initiated Trial (IIT) to minimize costs through collaboration with external investigators, while generating clinically meaningful data that can be applied in real-world treatment settings. Dr. Dipersio stated, “We’ll evaluate whether the repeated dosing strategy of NT-I7 can induce more sustained and robust therapeutic effects. Given the NT-I7’s impressive response rate observed in earlier studies, this trial has the potential to further validate the clinical applicability of NT-I7 and its value as a combination partner if successful.” A NeoImmuneTech representative commented, “This follow-up study presents an important opportunity to build upon existing evidence of the synergistic effect of NT-I7 with global CAR-T Therapies and to assess its potential for real-world clinical application.” *** ENDS ***

The release as fetched from its publisher. neoimmunetech.com ↗