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

NT-I7 to be administered twice following CAR-T infusion (Days 10 and 31); trial led by Dr. John DiPersio and Dr. Zachary D. Crees at Washington University School of Medicine in St. Louis Rapid initiation of follow-up study aims to expand NT-I7’s potential as a broadly applicable CAR-T combination therapy August 12, 2025 — ROCKVILLE, MD : NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a T cell-focused immunotherapy company, today announced that the U.S Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for a follow-up clinical trial evaluating the repeat dosing of its T cell amplifier NT-I7 (efineptakin alfa) in combination with CAR-T therapy. The trial is an Investigator-Initiated Trial (IIT) led by Dr. John DiPersio and Dr. Zachary D. Crees, both medical oncologists and blood cancer specialists at Washington University School of Medicine in St. Louis. It will enroll patients with relapsed or refractory large B-cell lymphoma (LBCL) who have previously received CD19-directed CAR-T therapies, such as Breyanzi® or Yescarta®. According to the protocol, NT-I7 will be administered on Days 10 and 31 after CAR-T infusion. Designed as a Phase 1b trial, the study will follow a 3+3 dose-escalation scheme, evaluating two dose levels (600 μg/kg and 700 μg/kg) in up to 12 patients to assess safety and tolerability. A subsequent Phase 2 expansion is planned to assess efficacy. Although CAR-T therapies typically show strong initial T cell expansion, non-responders often experience a sharp decline in CAR-T cell levels beyond Day 14. To address this, NeoImmuneTech and the investigators will explore whether administering NT-I7 earlier—on Day 10—followed by a second dose on Day 31 can help extend CAR-T cell persistence and enhance therapeutic durability. “ Dr. John DiPersio, who also led our prior NIT-112 study, has seen firsthand the potential of NT-I7 in combination with CAR-T,” said NeoImmuneTech. “His continued leadership in this follow-up trial underscores our confidence in NT-I7’s ability to further enhance the efficacy of CAR-T therapy.” In the previous Phase 1b trial (NIT-112), NT-I7 was administered as a single dose following CAR-T in patients with LBCL. In the high-dose cohort ( ≥ 480 μ g/kg, n=8), the study achieved a 100% best overall response rate (BOR), indicating a strong initial signal for the combination approach. *** ENDS ***

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