A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
City of Hope Medical Center
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.
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 toxicit…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureBiopsy
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureComputed Tomography
Undergo PET/CT
- BiologicalLoncastuximab Tesirine
Given IV
- BiologicalMosunetuzumab
Given IV
- ProcedurePositron Emission Tomography
Undergo PET/CT
Location
- City of Hope Medical CenterDuarte, California