Actively Recruiting
Phase 2 Study of Epcoritamab in Combination With Loncastuximab Tesirine in RelapsedRefractory Large B-cell Lymphoma
Led by University of Miami · Updated on 2026-03-02
26
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
A
ADC Therapeutics S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of two drugs, Epcoritamab and Loncastuximab Tesirine, to see if this treatment is tolerable and effective in reducing or eliminating lymphoma cells in adults with relapsed or refractory large B-cell lymphoma. This phase 2 study focuses on patients whose disease has returned or not responded to previous therapies, aiming to improve their treatment outcomes. Participants receiving the combination treatment will undergo up to four cycles of both Epcoritamab and Loncastuximab Tesirine, followed by eight additional cycles of Epcoritamab alone, totaling twelve treatment cycles. The first three cycles last 21 days each, while cycles four through twelve last 28 days each, with the entire treatment period lasting about 12 months. During the study, participants will be monitored for side effects related to the treatments, including specific toxicities such as cytokine release syndrome, neurotoxicity, fluid accumulation, and liver toxicity. Researchers will also assess treatment responses over up to 36 months, including overall response rate, progression-free survival, and overall survival. The total participation time in the study is approximately three years, involving regular health assessments and safety monitoring.
CONDITIONS
Brief Title
Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older at the time of signing informed consent
- Able and willing to sign the informed consent form
- Ability to comply with the trial protocol
- Diagnosed with relapsed or refractory large B-cell lymphoma as defined by WHO 2016 classification
- Received at least one prior systemic therapy for LBCL including anti-CD20 monoclonal antibody and anthracycline-containing therapy
- Measurable disease by 2014 Lugano Classification
- ECOG performance status of 0 to 2
- Adequate blood, liver, and kidney function within 6 weeks before therapy
- Willingness to avoid pregnancy during the trial and for at least 12 months after last dose
- Stable HIV patients on antiretroviral therapy with required lab values
- Life expectancy of at least 12 weeks
- For those on glucocorticoids, tapered to a maximum of 25 mg daily in the last 14 days before first dose of epcoritamab
You will not qualify if you...
- Primary central nervous system lymphoma or known CNS involvement by lymphoma
- Prior anti-CD19 CAR-T therapy
- Prior exposure to bispecific T-cell engaging antiCD20XCD3 antibodies
- Prior autologous or allogenic stem cell transplant
- Significant pulmonary disease affecting exercise tolerance
- Significant cardiac disease including recent unstable angina or heart attack
- Pregnant or breastfeeding
- Incomplete recovery from major surgery
- Active or recent severe infection requiring IV antibiotics
- Recent exposure to live vaccines or planned live vaccine during study
- Active hepatitis B or C infection
- Active SARS-CoV-2 infection
- Severe chronic pulmonary disease or other serious medical condition limiting treatment tolerance
- Seizure disorder with convulsions in past two years
- Impaired decision-making capacity
Research Team
J
Juan Alderuccio, MD
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