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Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

NCT05672251•City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This phase II trial studies the safety and how well of loncastuximab tesirine when given together with mosunetuzumab works in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, loncastuximab, linked to a toxic agent called tesirine. Loncastuximab attaches to anti-CD19 cancer cells in a targeted way and delivers tesirine to kill them. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving loncastuximab tesirine with mosunetuzumab may help treat patients with relapsed or refractory diffuse large B-cell lymphoma.

Detailed Description

PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of loncastuximab tesirine plus mosunetuzumab in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). (Safety Lead-In) II. Estimate the overall response rate (ORR) in R/R DLBCL patients treated with loncastuximab tesirine plus mosunetuzumab. (Phase 2) SECONDARY OBJECTIVES: I. Estimate the complete response (CR) rate, duration of response (DOR), progression-free survival (PFS), and overall survival (OS) in R/R DLBCL patients treated with loncastuximab tesirine plus mosunetuzumab. II. Evaluate the toxicity of loncastuximab tesirine plus mosunetuzumab for R/R DLBCL. EXPLORATROY OBJECTIVE: I. Evaluate genomic and immune biomarkers of response and resistance to loncastuximab tesirine combined with mosunetuzumab OUTLINE: Patients receive loncastuximab tesirine intravenously (IV) and mosunetuzumab IV on study. Patients also undergo positron emission tomography (PET)/computed tomography (CT) scan, biopsy, and collection of blood samples on study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented informed consent of the participant and/or legally authorized representative.
•* Assent, when appropriate, will be obtained per institutional guidelines.
•Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from diagnostic tumor biopsies.
•* If unavailable, exceptions may be granted with study principal investigator (PI) approval.
•Age: \>= 18 years.
•Eastern Cooperative Oncology Group (ECOG) =\< 2.
•Histologically confirmed diagnosis of diffuse large B-cell lymphoma or Follicular Lymphoma Grade 3B according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution. Subtypes of DLBCL including transformed indolent lymphomas (TIL) including Richter's Transformation, primary mediastinal large B-cell lymphoma (PMBCL), and high-grade B-cell lymphoma not otherwise specified (HGBCL-NOS) are eligible.
•Life expectancy \> 12 months.
•Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma Grade 3B according to the WHO classification, with hematopathology review at the participating institution. Subtypes of DLBCL including transformed indolent lymphomas (TIL) including Richter's Transformation, primary mediastinal large B-cell lymphoma (PMBCL), and high-grade B-cell lymphoma not otherwise specified (HGBCL-NOS) are eligible.
•Relapsed or refractory disease after \>= 1 prior line of therapy (prior CD19-directed therapy and prior autologous stem cell transplant are allowed).
+45 more criteria

Exclusion Criteria

•Prior treatment with loncastuximab tesirine.
•Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies.
•Prior allogeneic stem cell transplantation.
•Prior use of any monoclonal antibody, radioimmunoconjugate or ADC within 2 weeks prior to Day 1 of protocol therapy.
•Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to Day 1 of protocol therapy.
•Treatment with radiotherapy within 2 weeks prior to Day 1 of protocol therapy.
•* If patients have received radiotherapy within 4 weeks prior to prior to Day 1 of protocol therapy, patients must have at least one measurable lesion outside of the radiation field. Patients who have only one measurable lesion that was previously irradiated but subsequently progressed are eligible.
•Autologous stem cell transplantation (SCT) within 30 days prior to prior to Day 1 of protocol therapy.
•Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to Day 1 of protocol therapy.
•Live vaccine within 30 days prior to Day 1 of protocol therapy.
+13 more criteria

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Key Dates

Start Date

January 2, 2024

Primary Completion Date

April 7, 2026

Completion Date

April 7, 2026

Last Updated

October 6, 2025

Enrollment

ESTIMATED participants

Conditions

Recurrent Diffuse Large B-Cell LymphomaRecurrent Grade 3b Follicular LymphomaRecurrent High Grade B-Cell LymphomaRecurrent Primary Mediastinal (Thymic) Large B-Cell LymphomaRecurrent Transformed Chronic Lymphocytic LeukemiaRecurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell LymphomaRefractory Diffuse Large B-Cell LymphomaRefractory Grade 3b Follicular LymphomaRefractory High Grade B-Cell LymphomaRefractory Primary Mediastinal (Thymic) Large B-Cell LymphomaRefractory Transformed Chronic Lymphocytic LeukemiaRefractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

Interventions

Biopsy

PROCEDURE

Biospecimen Collection

PROCEDURE

Computed Tomography

PROCEDURE

Loncastuximab Tesirine

BIOLOGICAL

Mosunetuzumab

BIOLOGICAL

Positron Emission Tomography

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Inclusion Criteria

Exclusion Criteria

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma

Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma

Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Fludarabine and Cyclophosphamide With or Without Rituximab Before CD19 Chimeric Antigen Receptor T Cells for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Rituximab and Pembrolizumab With or Without Lenalidomide in Treating Patients With Relapsed Follicular Lymphoma and Diffuse Large B-Cell Lymphoma

Carfilzomib, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Stage I-IV Diffuse Large B-cell Lymphoma