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Monoclonal Antibodies

Epcoritamab for Chronic Lymphocytic Leukemia (EPCORE™ CLL-1 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Genmab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of CD20 positivity in a sample representative of the disease at Screening.

Life expectancy >3 months on standard of care (SOC).

Must not have

Clinically significant cardiac disease.

Received venetoclax within 24 months prior to beginning venetoclax ramp-up for this trial and progressed on treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for people with cancer who have tried other treatments that haven't worked. The drug will be given to people in different doses to see what works best, and then given to more people to see if it is safe and effective.

Who is the study for?

This trial is for patients with relapsed/refractory chronic lymphocytic leukemia or Richter's Syndrome who have tried other treatments. They must have a life expectancy over 3 months, acceptable organ function, and specific performance status. Prior therapies are required for certain arms of the study, and they must not have had certain conditions like HIV or recent major surgery.

What is being tested?

Epcoritamab is being tested both alone and in combination with venetoclax, lenalidomide, or R-CHOP (rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone) to treat chronic lymphocytic leukemia and Richter's Syndrome. The trial has two phases: dose escalation to find safe levels and expansion to test effectiveness.

What are the potential side effects?

Potential side effects include reactions related to the immune system due to epcoritamab targeting CD20 on cancer cells. Other side effects may arise from chemotherapy combinations such as nausea, hair loss, increased infection risk, fatigue, blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My disease shows CD20 positivity in tests.

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My doctor expects me to live more than 3 months with standard treatment.

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I can provide a specific type of tumor biopsy sample.

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I can take care of myself and am up and about more than half of my waking hours.

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My chronic lymphocytic leukemia needs treatment according to 2018 guidelines.

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I have CLL and have been treated with at least 2 therapies, including a BTK inhibitor.

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My cancer is CD20+ DLBCL and I have a history of CLL/SLL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I took venetoclax in the last 2 years and my condition worsened on it.

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I have had more than 2 treatments for my condition before considering this therapy.

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I do not have any cancer other than the one I am seeking treatment for.

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I haven't had CAR T-cell therapy in the last 100 days or any experimental drugs in the last 4 weeks.

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My condition is Richter's syndrome, not including the DLBCL type.

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I have an autoimmune disease or require high-dose immunosuppressants.

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I have had a stem cell or organ transplant before.

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I have a known history of HIV.

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I have active hepatitis B or C.

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My CLL may have transformed into a more aggressive form.

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I have been treated with a specific dual-targeted antibody therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation Phase (R/R CLL arm): Number of Participants with Dose Limiting Toxicities (DLTs)

Dose Escalation Phase: Number of Participants with Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and Clinical Tumor Lysis Syndrome (CTLS)

Expansion Phase: Overall Response Rate (ORR)

Secondary study objectives

Both Phases: Duration of MRD Negativity

Both Phases: Duration of Response (DOR)

Both Phases: Lymphoid Cells for Immunophenotyping

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