NeoImmuneTech Announces FDA IND Clearance for NIT-128, a Combination Trial of NT-I7 with BCMA CAR-T Therapy in Multiple Myeloma

FDA clears IND for investigator-initiated study combining NT-I7 with CARVYKTI® in patients with multiple myeloma Program aims to enhance immune restoration and extend durability of responses following CAR-T therapy, further expanding NT-I7’s CAR-T combination portfolio November 20, 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 cleared the Investigational New Drug (IND) application for NIT-128 , an investigator-initiated trial (IIT) evaluating the combination of NT-I7 (efineptakin alfa) with Janssen’s BCMA-targeted CAR-T therapy CARVYKTI® (cilta-cel) in patients with multiple myeloma (MM). The study will be conducted at Washington University School of Medicine in St. Louis , led by Dr. Michael Slade , Assistant Professor of Oncology, with Dr. John DiPersio , Professor of Oncology, participating as co-investigator. Following a dose-finding cohort, the randomized, the randomized, double-blind, placebo-controlled study will enroll 40 patients with relapsed or refractory MM to assess safety and tolerability of NT-I7 following CAR-T therapy, while also exploring key efficacy endpoints, including Complete Response (CR) rates . Participants in the NT-I7 arm will receive intramuscular injections Day 14 and Day 35 after CAR-T infusion; the control arm will receive placebo on the same schedule. The trial is designed to evaluate whether NT-I7 can enhance immune reconstitution and sustain CAR-T-cell-mediated responses, with the goal of improving long-term remission and survival outcomes for patients undergoing CAR-T therapy. “CAR-T therapy is highly effective at inducing remission in multiple myeloma, but relapse remains a significant challenge for most patients,” said Dr. Slade . “By adding NT-I7, we aim to enhance the expansion and persistence of CAR-T cells, potentially leading to more durable, long-term responses.” Tae Woo Kim , acting CEO of NeoImmuneTech, added: “LBCL and MM represent two of the most commercially significant opportunities in the CAR-T field, and it is highly meaningful that NeoImmuneTech is now initiating clinical trials in both. NT-I7 is also being evaluated in combination with all three of the world’s top-selling FDA-approved CAR-T therapies—Yescarta®, CARVYKTI®, and Breyanzi®—underscoring the strategic importance of our program. The early and active involvement of leading global medical centers provides a strong foundation for future licensing discussions with global pharmaceutical partners.” With the prior IND clearance of NIT-126 , a CD19 CAR-T combination trial in large B-cell lymphoma (LBCL), and now the approval of NIT-128 for BCMA CAR-T therapy in multiple myeloma, NeoImmuneTech has further strengthened its dual-pillar CAR-T combination portfolio . These programs support a broader strategy to build clinical evidence that NT-I7 can enhance T-cell recovery and improve long-term outcomes following CAR-T therapy. *** ENDS ***

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