Epcoritamab + Loncastuximab Tesirine for B-Cell Lymphoma
(EPCOR+LONCA Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on glucocorticoid treatment, it must be reduced to a maximum of 25 mg daily in the last 14 days before starting the trial.
What data supports the effectiveness of the drug combination Epcoritamab and Loncastuximab Tesirine for B-Cell Lymphoma?
Epcoritamab has shown strong anti-tumor activity in B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), by engaging T-cells to attack cancer cells. Loncastuximab Tesirine has demonstrated effectiveness in treating relapsed or refractory DLBCL, with a notable response rate in clinical trials. Both drugs have been individually effective in similar conditions, suggesting potential when combined.12345
Is the combination of Epcoritamab and Loncastuximab Tesirine safe for humans?
Loncastuximab Tesirine has been shown to have an acceptable safety profile in clinical trials for B-cell non-Hodgkin lymphoma, with common side effects including low blood cell counts, fatigue, nausea, and liver enzyme changes. Epcoritamab has also demonstrated safety in early trials for B-cell lymphoma, but specific safety data for the combination of these two drugs is not available.12467
What makes the drug combination of Epcoritamab and Loncastuximab Tesirine unique for treating B-cell lymphoma?
This drug combination is unique because Epcoritamab is a bispecific antibody that engages T-cells to target and kill cancerous B-cells, while Loncastuximab Tesirine is an antibody-drug conjugate that delivers a toxic payload directly to B-cells. Together, they offer a novel approach by combining two different mechanisms to attack B-cell lymphoma.12348
What is the purpose of this trial?
The purpose of this study is to determine whether combining Loncastuximab Tesirine with Epcoritamab is tolerable and effective for reducing and/or eliminating lymphoma cells in the body.
Research Team
Juan Alderuccio, MD
Principal Investigator
University of Miami
Eligibility Criteria
Adults with relapsed/refractory large B-cell lymphoma who've had at least one prior treatment including anti-CD20 antibody and anthracycline. They must have a life expectancy of 12 weeks, manageable health status (ECOG PS 0-2), and adequate organ function. HIV-positive patients can join under certain conditions. Exclusions include CNS lymphoma involvement, pregnancy, severe chronic diseases, recent major surgery complications, active hepatitis B or C infection, previous CAR-T therapy or stem cell transplant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 4 cycles of combination EPCOR and LONCA therapy, followed by an additional 8 cycles of EPCOR therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
Treatment Details
Interventions
- Epcoritamab
- Loncastuximab Tesirine
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
ADC Therapeutics S.A.
Industry Sponsor
Genmab
Industry Sponsor
Dr. Jan van de Winkel
Genmab
Chief Executive Officer since 2010
PhD in Immunology, University of Utrecht
Dr. Judith Klimovsky
Genmab
Chief Medical Officer since 2019
MD, University of Copenhagen