Citius Oncology Announces Topline Results From Investigator‑Initiated Phase 1 Trial Of LYMPHIR Administered Prior To Commercial CD19‑Directed CAR‑T Therapy In High‑Risk DLBCL; Co Says LYMPHIR Was Well-Tolerated With No Dose-Limiting Toxicities Observed

Topline data of investigator‑initiated study at the University of Minnesota and City of Hope demonstrates 86% overall response rate (OR), including 57% complete response (CR) and 29% partial response (PR)

LYMPHIR was well-tolerated with no dose-limiting toxicities observed

CRANFORD, N.J., March 4, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (NASDAQ:CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (NASDAQ:CTXR), today announced positive topline safety and efficacy results from an investigator‑initiated Phase 1 trial evaluating LYMPHIR™ (E7777, denileukin diftitox‑cxdl) administered prior to commercial CD19‑directed CAR‑T therapy in patients with high‑risk relapsed or refractory diffuse large B‑cell lymphoma (DLBCL). The trial was conducted by lead investigator, Dr. Veronika Bachanova, at the University of Minnesota and City of Hope. Full results were presented at the 2026 ASTCT® & CIBMTR® Tandem Meetings.

The Phase 1 trial was designed to augment the lymphodepletion regimen prior to CAR‑T infusion through the administration of LYMPHIR to potentially improve the anti‑tumor activity of CAR‑T therapies. LYMPHIR, an engineered fusion toxin that preferentially binds to the IL‑2 receptor expressed on regulatory T-cells (Tregs), is currently FDA-approved and commercially available for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after one prior systemic therapy.