Citius Oncology Unveils Phase 1 Results for LYMPHIR™ Prior to CAR-T Therapy in High-Risk DLBCL Patients
Citius Oncology, Inc. recently shared encouraging preliminary results from a Phase 1 trial examining the use of LYMPHIR™ (E7777, denileukin diftitox-cxdl) in patients with high-risk diffuse large B-cell lymphoma (DLBCL), prior to their CAR-T therapy treatment. Conducted by Dr. Veronika Bachanova at institutions including the University of Minnesota and City of Hope, the trial's findings were discussed at the 2026 ASTCT® CIBMTR® Tandem Meetings.
In this open-label, dose-escalation study, LYMPHIR was administered to 14 patients suffering from relapsed or refractory DLBCL, exhibiting serious prognostic features such as double/triple hit genetics. The key goal was to enhance the lymphodepletion process preceding CAR-T infusion by utilizing LYMPHIR, which is an engineered fusion protein targeting the IL-2 receptor found on regulatory T-cells (Tregs).
The results demonstrated a remarkable 86% overall response rate (ORR) within one month post-treatment, comprising 57% complete responses (CR) and 29% partial responses (PR). Furthermore, the one-year progression-free survival (PFS) was reported at 77%, and overall survival (OS) at 84%. Notably, LYMPHIR was well-tolerated by patients, with no observed dose-limiting toxicities.
LYMPHIR’s pharmacological action involves depleting immunosuppressive regulatory T lymphocytes, thus potentially enabling a more robust anti-tumor immune response when combined with CAR-T therapies. The study indicated significant depletion of circulating Tregs in all but one participant, marking a median reduction of 24 Tregs/µL, with the nadir noted 24 hours post-LYMPHIR administration.
Dr. Myron Czuczman, the Chief Medical Officer of Citius Oncology, emphasized that enhancing Treg depletion before CAR-T infusions with LYMPHIR provides a promising immunomodulatory strategy in patients facing significant treatment challenges due to DLBCL. This could signal a significant advancement in the CAR-T landscape for high-risk individuals.
Most adverse events recorded were manageable, including low-grade cytopenias and capillary leak syndrome at Grades 1-2. Notably, cytokine release syndrome, commonly observed in CAR-T therapies, ensued in 43% of participants but was predominantly classified as Grade 1 or 2.
These preliminary results suggest a potent synergy between LYMPHIR and CAR-T therapies, advocating for further research to explore how extended LYMPHIR administration may enhance CAR-T efficacy. As DLBCL remains the most frequent subtype of non-Hodgkin lymphoma in the U.S., affecting nearly 30%-40% of newly diagnosed cases, this combination therapy represents a lifeline for patients confronting refractory or recurrent manifestations of this aggressive malignancy.
In conclusion, the positive safety and efficacy signals from this Phase 1 trial provide Citius Oncology with a robust foundation for future larger-scale studies aimed at better understanding LYMPHIR's role in improving treatment outcomes for high-risk DLBCL. The study also underscores Citius Oncology's commitment to finding innovative solutions within the oncology realm. As they move forward, the hope is that LYMPHIR can significantly transform the therapeutic landscape for patients battling severe lymphomas.
In this open-label, dose-escalation study, LYMPHIR was administered to 14 patients suffering from relapsed or refractory DLBCL, exhibiting serious prognostic features such as double/triple hit genetics. The key goal was to enhance the lymphodepletion process preceding CAR-T infusion by utilizing LYMPHIR, which is an engineered fusion protein targeting the IL-2 receptor found on regulatory T-cells (Tregs).
The results demonstrated a remarkable 86% overall response rate (ORR) within one month post-treatment, comprising 57% complete responses (CR) and 29% partial responses (PR). Furthermore, the one-year progression-free survival (PFS) was reported at 77%, and overall survival (OS) at 84%. Notably, LYMPHIR was well-tolerated by patients, with no observed dose-limiting toxicities.
LYMPHIR’s pharmacological action involves depleting immunosuppressive regulatory T lymphocytes, thus potentially enabling a more robust anti-tumor immune response when combined with CAR-T therapies. The study indicated significant depletion of circulating Tregs in all but one participant, marking a median reduction of 24 Tregs/µL, with the nadir noted 24 hours post-LYMPHIR administration.
Dr. Myron Czuczman, the Chief Medical Officer of Citius Oncology, emphasized that enhancing Treg depletion before CAR-T infusions with LYMPHIR provides a promising immunomodulatory strategy in patients facing significant treatment challenges due to DLBCL. This could signal a significant advancement in the CAR-T landscape for high-risk individuals.
Most adverse events recorded were manageable, including low-grade cytopenias and capillary leak syndrome at Grades 1-2. Notably, cytokine release syndrome, commonly observed in CAR-T therapies, ensued in 43% of participants but was predominantly classified as Grade 1 or 2.
These preliminary results suggest a potent synergy between LYMPHIR and CAR-T therapies, advocating for further research to explore how extended LYMPHIR administration may enhance CAR-T efficacy. As DLBCL remains the most frequent subtype of non-Hodgkin lymphoma in the U.S., affecting nearly 30%-40% of newly diagnosed cases, this combination therapy represents a lifeline for patients confronting refractory or recurrent manifestations of this aggressive malignancy.
In conclusion, the positive safety and efficacy signals from this Phase 1 trial provide Citius Oncology with a robust foundation for future larger-scale studies aimed at better understanding LYMPHIR's role in improving treatment outcomes for high-risk DLBCL. The study also underscores Citius Oncology's commitment to finding innovative solutions within the oncology realm. As they move forward, the hope is that LYMPHIR can significantly transform the therapeutic landscape for patients battling severe lymphomas.
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