Actively Recruiting
A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Led by City of Hope Medical Center ยท Updated on 2026-05-11
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of loncastuximab tesirine combined with mosunetuzumab in treating adults with diffuse large B-cell lymphoma that has returned or not responded to previous treatments. This phase II trial focuses on patients with relapsed or refractory disease, including various subtypes of this lymphoma. The study also aims to assess genomic and immune markers related to how patients respond or resist this combination therapy. Participants receive loncastuximab tesirine and mosunetuzumab intravenously during the study. These treatments are monoclonal antibodies designed to target and kill cancer cells. Alongside treatment, patients undergo PET/CT scans, biopsies, and blood sample collections to monitor the disease and treatment effects throughout the trial. During the study, participants will be regularly assessed for safety and response to treatment, including measuring tumor size and progression via imaging and laboratory tests. Researchers will track key outcomes such as response rates, duration of response, progression-free survival, and overall survival for up to two years after the last dose. Safety will be closely monitored up to 30 days after treatment ends, and patients' overall health and treatment tolerability will be evaluated throughout their participation.
CONDITIONS
Brief Title
Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent from participant or legal representative.
- Willing to provide tissue from a recent or diagnostic tumor biopsy.
- Age 18 years or older.
- ECOG performance status of 0, 1, or 2.
- Confirmed diagnosis of diffuse large B-cell lymphoma or Follicular Lymphoma Grade 3B, including certain subtypes.
- Life expectancy more than 12 months.
- Relapsed or refractory disease after at least one prior therapy.
- Measurable disease with at least one tumor site 1.5 cm or larger.
- Tumor positive for CD19 and CD20 markers.
- Recovered from prior anti-cancer therapy side effects to Grade 1 or less, except hair loss.
- Adequate blood counts and organ function as specified.
- Women of childbearing potential must have negative pregnancy test and agree to birth control requirements.
- Men must agree to use contraception during and after treatment periods.
You will not qualify if you...
- Previous treatment with loncastuximab tesirine or mosunetuzumab.
- Prior allogeneic stem cell transplant.
- Recent use of monoclonal antibodies, chemotherapy, other anti-cancer agents, or radiotherapy within specified timeframes before study start.
- Recent autologous stem cell transplant or CAR-T therapy within 30 days.
- Live vaccine within 30 days before starting treatment.
- Current investigational therapy or immune-related side effects from prior immunotherapies.
- Uncontrolled illness or active infections including hepatitis B, hepatitis C, or active HIV infection.
- History of certain autoimmune diseases or significant cardiac, liver, or neurological conditions.
- Pregnant or breastfeeding women.
- Any condition that the investigator believes would make participation unsafe or interfere with study compliance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years post-last dose
Participants receive loncastuximab tesirine and mosunetuzumab intravenously. They also undergo PET/CT scans, biopsies, and blood sample collections during the study.
Multiple visits including treatment and assessment visits throughout the treatment period
Duration - Up to 2 years post-last dose
Participants are monitored for safety, response to treatment, and survival outcomes after treatment ends.
Visits as scheduled for safety and response assessments
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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