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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05672251
Phase
PHASE2
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Loncastuximab Tesirine — BIOLOGICAL
    Given IV
  • Mosunetuzumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

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.

Key Dates

Start date
Jan 2, 2024
Status verified
Oct 2025
Primary completion
Mar 23, 2027
Completion
Mar 23, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (oncastuximab tesirine, mosunetuzumab)
    Patients receive loncastuximab tesirine IV and mosunetuzumab IV on study. Patients also undergo PET/CT scan, biopsy, and collection of blood samples on study.

Primary Outcome Measure

Unacceptable toxicity (Safety Lead-in) [ Time Frame: Up to 30 days post-last dose of protocol therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Swetha Kambhampati
[email protected]
626-256-4673
Swetha Kambhampati (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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