Trials / Recruiting
RecruitingNCT05672251
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Recurrent Diffuse Large B-Cell Lymphoma
- Recurrent Grade 3b Follicular Lymphoma
- Recurrent High Grade B-Cell Lymphoma
- Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Recurrent Transformed Chronic Lymphocytic Leukemia
- Recurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
- Refractory Diffuse Large B-Cell Lymphoma
- Refractory Grade 3b Follicular Lymphoma
- Refractory High Grade B-Cell Lymphoma
- Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Refractory Transformed Chronic Lymphocytic Leukemia
- Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biopsy | Undergo biopsy |
| PROCEDURE | Biospecimen Collection | Undergo collection of blood samples |
| PROCEDURE | Computed Tomography | Undergo PET/CT |
| BIOLOGICAL | Loncastuximab Tesirine | Given IV |
| BIOLOGICAL | Mosunetuzumab | Given IV |
| PROCEDURE | Positron Emission Tomography | Undergo PET/CT |
Timeline
- Start date
- 2024-01-02
- Primary completion
- 2026-04-07
- Completion
- 2026-04-07
- First posted
- 2023-01-05
- Last updated
- 2025-10-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05672251. Inclusion in this directory is not an endorsement.