Actively Recruiting
Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Led by City of Hope Medical Center · Updated on 2026-05-11
36
Participants Needed
1
Research Sites
168 weeks
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
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.
CONDITIONS
Official 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...
- Provide documented informed consent and assent if applicable per guidelines
- Willing to provide tissue from a fresh biopsy or diagnostic tumor biopsy before treatment
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Confirmed diagnosis of diffuse large B-cell lymphoma or Follicular Lymphoma Grade 3B, including specified subtypes
- Life expectancy greater than 12 months
- Relapsed or refractory disease after at least one prior therapy, including prior CD19-directed therapy or autologous stem cell transplant
- Measurable disease with at least one lesion 1.5 cm or larger by CT or PET/CT
- Tumor positive for CD19 and CD20 markers after most recent therapy
- Recovery from prior anti-cancer therapy toxic effects to Grade 1 or less (except alopecia)
- Absolute neutrophil count (ANC) of at least 1,000/mm³ if no bone marrow involvement; no minimum ANC if marrow involved
- Platelet count of at least 75,000/mm³
- Total bilirubin no more than 1.5 times upper limit of normal (ULN), or 3 times ULN if liver lymphoma involvement or Gilbert's disease
- AST and ALT levels within specified limits depending on liver involvement
- Creatinine clearance of at least 40 mL/min
- Coagulation tests (INR/PT and aPTT) within normal or therapeutic ranges depending on anticoagulant use
- Negative pregnancy test if woman of childbearing potential
- Agreement to use effective contraception or abstain from heterosexual intercourse during and after treatment as specified
You will not qualify if you...
- Prior treatment with loncastuximab tesirine or mosunetuzumab or other CD20-directed bispecific antibodies
- Prior allogeneic stem cell transplantation
- Recent use of monoclonal antibodies, chemotherapy, anti-cancer agents, or radiotherapy within specified timeframes before study therapy
- Autologous stem cell transplant or CAR-T therapy within 30 days before treatment
- Live vaccine within 30 days before treatment
- Concomitant investigational therapy
- Significant immune-related adverse events from prior immunotherapies unless approved by study PI
- High-dose systemic steroids or other immunosuppressive therapies above specified levels
- Allergies to study drug components
- Significant fluid accumulation requiring drainage
- History of solid organ transplant, progressive multifocal leukoencephalopathy, hemophagocytic lymphohistiocytosis
- Uncontrolled illnesses or active infections excluding nail fungal infections
- Active hepatitis B or C infection or active HIV infection unless controlled
- Active central nervous system lymphoma involvement
- Severe rash or blistering from prior immunomodulatory treatments
- Recent major surgery within 4 weeks before treatment
- History of other primary cancers not in remission for 2 years, with some exceptions
- Pregnant or breastfeeding females
- Any other condition or inability to comply with study procedures as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here