NeoImmuneTech Announces U.S. FDA IND Submission for Combination Trial of NT-I7 with BCMA CAR-T Therapy Led by Washington University of Medicine in St. Louis— Expanding Its CAR-T Combination Strategy

NT-I7 to be evaluated in combination with BCMA CAR-T therapy Double-blind, placebo-controlled, randomized, single-site phase 1 study of 40 patients to assess immune recovery following CAR-T treatment Strengthening data generation and market expansion through global investigator-initiated trials October 31, 2025 — ROCKVILLE, MD : NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a T cell-focused immunotherapy company, announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a combination clinical trial of NT-I7 with BCMA CAR-T therapy (Cilta-cel, brand name Carvykti ) in patients with multiple myeloma (MM). This follows the company’s ongoing CD19 CAR-T combination study (NIT-126) in patients with large B-cell lymphoma (LBCL). The new study is an investigator-initiated trial (IIT) led by Dr. Michael Slade, an assistant professor of medicine in the Division of Oncology at Washington University School of Medicine in St. Louis, in collaboration with Dr. John F. DiPersio, a professor of medicine in the Division of Oncology. The Phase 1 clinical trial will enroll 40 patients with relapsed or refractory multiple myeloma to evaluate the safety and tolerability of NT-I7 administered after CAR-T therapy, while also exploring efficacy endpoints such as complete response (CR). The study is designed as a double-blind, placebo-controlled, randomized, single-site study. Patients in the NT-I7 arm will receive intramuscular injections of NT-I7 on Day 14 and Day 35 following CAR-T treatment, while the control arm will receive a placebo on the same schedule. The clinical trial will evaluate whether the combination of NT-I7 with standard-of-care BCMA CAR-T therapy is safe and tolerable and provide preliminary data regarding whether this combination may improve clinical outcomes for patients. Dr. Slade commented, “While CAR-T cell therapy is extremely effective at putting myeloma into remission, relapse after treatment is nearly universal and remains a significant challenge. We hope that the addition of NT-I7 to standard-of-care therapy may help us move from “control” to “cure” by enhancing CAR-T cell expansion and persistence. This study is an important first step to demonstrate this combination is safe and will also yield important data regarding the association of immune recovery and long-term response.” A NeoImmuneTech representative stated, “We expect the data generated from this study to serve as an important basis for potential licensing discussions with major global pharmaceutical partners. By collaborating with external investigators, we are pursuing a strategic approach that enhances cost efficiency while securing independent clinical data from leading global institutions.” Janssen’s multiple myeloma therapy Carvykti (Cilta-cel) recorded annual sales of USD 963 million in 2024 and USD 524 million in Q3 2025, marking an 83.5% year-over-year growth, underscoring the strong and expanding market potential for BCMA CAR-T therapies. *** ENDS ***

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