CRANFORD, N.J., March 4, 2026

Citius Oncology announced encouraging preliminary topline results from a Phase 1 clinical study evaluating the oncology therapy LYMPHIR™ (E7777) administered prior to commercial CAR-T cell therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The investigator-initiated trial, conducted at the University of Minnesota and City of Hope, demonstrated an impressive 86% overall response rate, including 57% complete responses and 29% partial responses, highlighting the potential of the therapy to enhance immune-based cancer treatments. Importantly, the treatment showed a favorable safety profile with no dose-limiting toxicities observed, reinforcing its potential role in improving CAR-T therapy outcomes for difficult-to-treat lymphoma patients.

Phase 1 Study Demonstrates Strong Clinical Response

The Phase 1 open-label dose-escalation trial enrolled 14 patients with aggressive DLBCL who exhibited high-risk disease characteristics such as double-hit genetics, refractory disease, or extranodal involvement. These patients often have limited treatment options and poor outcomes with standard therapies.

Participants received a single dose of LYMPHIR (E7777) prior to undergoing standard CD19-directed CAR-T cell therapy, a treatment that reprograms a patient’s immune cells to attack cancer. All 14 patients successfully completed treatment and proceeded to CAR-T infusion, demonstrating that the drug could be safely incorporated into the treatment regimen.

Key clinical findings included:

86% overall response rate (ORR) within one month of treatment

57% complete responses (CR) and 29% partial responses (PR)

77% one-year progression-free survival rate

84% one-year overall survival rate

These results suggest that LYMPHIR may enhance the anti-tumor activity of CAR-T therapies by improving immune cell preparation prior to infusion, offering a promising strategy to boost treatment responses in patients with advanced lymphoma.

Innovative Immunotherapy Targets Regulatory T Cells

LYMPHIR represents a novel targeted immunotherapy designed to modulate the immune system by selectively binding to IL-2 receptors on regulatory T-cells (Tregs). These cells normally suppress immune responses and can protect tumors from immune attack. By depleting immunosuppressive T-cells before CAR-T infusion, the therapy aims to create a more favorable environment for engineered immune cells to eliminate cancer.

The drug is a recombinant fusion protein combining the IL-2 receptor binding domain with diphtheria toxin fragments, which disrupt protein synthesis in targeted cells and ultimately trigger tumor cell death. This mechanism allows the therapy to selectively eliminate T-cells that inhibit immune responses, enhancing the effectiveness of other immunotherapies.

LYMPHIR has already received regulatory approval for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) in patients who have undergone prior systemic therapy, and it was launched commercially in the United States in December 2025. The ongoing research aims to expand its use as part of combination immunotherapy strategies for other hematologic cancers and immune-related conditions.

Potential Breakthrough for High-Risk Lymphoma Patients

Diffuse large B-cell lymphoma is the most common subtype of non-Hodgkin lymphoma, accounting for approximately 30–40% of newly diagnosed cases in the United States. Although frontline treatments such as chemoimmunotherapy can cure many patients, up to 40% experience relapse or refractory disease, leaving them with limited therapeutic options.

Researchers believe that modulating the immune microenvironment before CAR-T therapy may significantly improve outcomes by enabling the engineered immune cells to function more effectively. The early results from the LYMPHIR study provide strong evidence supporting this approach and could lead to larger clinical trials evaluating the therapy in combination with CAR-T treatments.

Experts note that combination immunotherapy strategies are rapidly emerging as a major focus in oncology research, particularly in cases where existing treatments fail to achieve durable responses. If future studies confirm the current findings, LYMPHIR could become a key immunomodulatory therapy that enhances CAR-T treatments and improves survival outcomes for patients with aggressive lymphomas.

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Source: Citius Oncology press release