CTOR · Citius Oncology, Inc.

Summary

Citius Oncology, Inc. announced positive topline safety and efficacy results from an investigator-initiated Phase 1 trial evaluating LYMPHIR™ administered prior to commercial CD19-directed CAR-T therapy in 14 patients with high-risk relapsed or refractory DLBCL, reporting an 86% overall response rate including 57% complete responses and no dose-limiting toxicities.

Key takeaways

• Phase 1 trial (NCT04855253) enrolled 14 high-risk relapsed/refractory DLBCL patients
• LYMPHIR dosed at 5, 7, or 9 µg/kg prior to CAR-T (Yescarta®, Breyanzi®, or Kymriah®)
• 86% ORR at one month (57% CR, 29% PR)
• 77% one-year PFS (95% CI: 43–92%)
• 84% one-year OS (95% CI: 49–96%)
• No dose-limiting toxicities; effective Treg depletion in 13/14 patients