Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT05672251
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2023-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-10312 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 22414 | OTHER | City of Hope Medical Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |