Epcoritamab for CLL
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Epcoritamab for individuals with Chronic Lymphocytic Leukemia (CLL) or a similar condition. The researchers aim to determine if Epcoritamab can reduce cancer cells in patients previously treated with specific medications but still showing detectable disease. Participants should have received a second-generation BTKi, such as acalabrutinib or zanubrutinib, for at least a year and still exhibit signs of the disease. The trial seeks to discover if adding Epcoritamab to current treatments can improve CLL management. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in CLL management.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. However, it does mention that patients who require anti-coagulation with warfarin or similar medications are excluded, so you may need to discuss your specific medications with the trial team.
Is there any evidence suggesting that Epcoritamab is likely to be safe for humans?
Research has shown that epcoritamab yields promising results for patients with difficult-to-treat chronic lymphocytic leukemia (CLL). In earlier studies, patients responded well to the treatment, and it was generally safe. Although the treatment is usually well-tolerated, it can have side effects, as with any medication. Some unwanted effects have been reported, but these are often manageable. The treatment's progress through the trial phases indicates it is considered safe enough for further study in more people.12345
Why are researchers excited about this trial's treatment?
Epcoritamab is unique because it introduces a new way to treat chronic lymphocytic leukemia (CLL) by using a bispecific antibody that targets both cancer cells and the immune system. Unlike standard treatments like BTK inhibitors, which primarily block signals needed for cancer cell survival, Epcoritamab directly engages T-cells to attack the cancer. This subcutaneous injection offers a novel mechanism by actively recruiting the body's immune response, potentially leading to more effective and sustained cancer control. Researchers are excited because this approach could enhance the immune system's ability to recognize and destroy cancer cells, offering hope for patients who may not respond to current therapies.
What evidence suggests that Epcoritamab could be an effective treatment for CLL?
This trial studies Epcoritamab in combination with standard-of-care (SOC) drugs for chronic lymphocytic leukemia (CLL). Studies have shown that Epcoritamab, when used alone, effectively treats CLL and a related condition called Richter's syndrome. In earlier research, 62% of patients with recurrent or hard-to-treat CLL responded well to the treatment. Among these patients, 33% achieved a complete response, with no signs of cancer detected. Epcoritamab targets cancer cells and aids the immune system in attacking them. These results are promising, especially for patients who have already tried other treatments.12678
Are You a Good Fit for This Trial?
This trial is for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), who have been treated with a second-generation BTK inhibitor, possibly alongside Obinutuzumab. Specific eligibility details are not provided but typically include factors like age, health status, and prior treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 12 cycles of epcoritamab as consolidation therapy following BTKi +/- obinutuzumab treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may continue BTKi as monotherapy after completing 12 cycles of epcoritamab
What Are the Treatments Tested in This Trial?
Interventions
- Epcoritamab
Trial Overview
The study is testing Epcoritamab as an additional treatment ('consolidation therapy') after initial therapy with a second-generation BTK inhibitor and potentially Obinutuzumab in CLL/SLL patients. It's a phase 2 trial which means it focuses on the drug's effectiveness and side effects.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Epcoritamab is the investigational product under study in combination with SOC drugs in this protocol. During C1, epcoritamab will be initiated using step-up dosing (SUD) C1D1 .16mg, C1D8 .8mg, C1D15 3 mg, C1D22 24 mg vs 48 mg (full dose) during safety lead in to determine the RP2D. On Cycles 2-3 the RP2D (24mg vs 48 mg) will be administered on Days 1, 8, 15, 22. Then Cycles 4-9 RP2D will be administered on Days 1 \& 15. Then Cycle 10-12 RP2D on Day 1 of each cycle. Epcoritamab is administered subcutaneously. The SOC BTKi are oral medications administered daily during the trial period.
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Who Is Running the Clinical Trial?
Zulfa Omer
Lead 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
Citations
1.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/883/531051/Epcoritamab-Monotherapy-in-Patients-Pts-withEpcoritamab Monotherapy in Patients (Pts) with Relapsed or ...
Epcoritamab has shown promising single-agent efficacy in both R/R CLL and Richter's syndrome in early data from EPCORE CLL-1 (phase 1b/2; NCT ...
2.
cancernetwork.com
cancernetwork.com/view/subcutaneous-epcoritamab-elicits-deep-responses-in-heavily-pretreated-cllSubcutaneous Epcoritamab Elicits Deep Responses in ...
Epcoritamab-bysp (Epkinly) monotherapy demonstrated clinical activity with deep responses in heavily pretreated patients with chronic lymphocytic leukemia (CLL ...
CLL-280 Epcoritamab Induces Deep Responses in ...
Conclusions. Epcoritamab showed encouraging efficacy with a consistent safety profile in a high-risk RT cohort. Response rates were notably higher in patients ...
Solid Results for Epcoritimab for Relapsed / Refractory CLL
Solid Results for Epcoritimab for Relapsed / Refractory CLL · 62% or 13 patients responded, with 33% or seven patients having a complete response ...
NCT04623541 | Safety and Efficacy Study of Epcoritamab ...
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20).
Safety and Efficacy Study of Epcoritamab in Subjects With ...
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20).
7.
cllsociety.org
cllsociety.org/2025/02/promising-results-in-difficult-to-treat-cll-with-epcoritamab/Promising Results in Difficult-to-Treat CLL with Epcoritamab
Epcoritamab, a novel bispecific antibody monotherapy, showed strong results in relapsed / refractory high-risk CLL patients running out of options.
8.
clinical-lymphoma-myeloma-leukemia.com
clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(24)01274-6/abstractCLL-280 Epcoritamab Induces Deep Responses in ...
Conclusions. Epcoritamab showed encouraging efficacy with a consistent safety profile in a high-risk RT cohort. Response rates were notably higher in patients ...
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