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RecruitingLast updated: 1 May 2024

EPCORE™ CLL-1: This study is evaluating how safe and effective targeted therapy (called epcoritamab) is when given alone, or in combination with other cancer treatments, in people with relapsed or refractory chronic lymphocytic leukaemia, small lymphocytic lymphoma, or Richter's SyndromeA Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

Clinical summary

Summary

This study is recruiting people with relapsed or refractory (R/R) Chronic Lymphocytic Leukaemia (CLL), small lymphocytic lymphoma (SLL), and people with Richter's Syndrome (RS).

The study will be evaluating targeted therapy (called epcoritamab) either as:

  • Monotherapy, or
  • Combination therapy:
    • epcoritamab + venetoclax (another type of targeted therapy)
    • epcoritamab + lenalidomide (a drug that affects cancer growth)
    • epcoritamab + R-CHOP (combination chemotherapy).

This study has two phases: Dose Escalation and Dose Expansion.

The purpose of the Dose Escalation phase is to determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD; if reached) as well as establish the safety profile of epcoritamab monotherapy, and epcoritamab + venetoclax in participants with relapsed or refractory R/R CLL. 

The purpose of the Expansion phase is to assess and evaluate the preliminary efficacy, safety and tolerability profiles of epcoritamab monotherapy and epcoritamab + venetoclax at the RP2D for participants with R/R CLL/SLL. Along with this, epcoritamab monotherapy, epcoritamab + lenalidomide, and epcoritamab + R-CHOP will be evaluated in participants with RSto assess their efficacy, safety and tolerability profiles.

Conditions

This trial is treating patients with relapsed/refractory chronic lymphocytic leukaemia, small lymphocytic lymphoma and Richter's Syndrome

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

Trial Acronym

EPCORE™ CLL-1

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT04623541
  • GCT3013-03; 2020-000848-57; NL74221.056.20; MOH_2023-04-02_012496

Trial sponsor

Genmab

Scientific Title

A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

Eligibility

Inclusion

  1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
  2. Evidence of CD20 positivity in a sample representative of the disease at Screening.
  3. Acceptable hematology parameters and organ function based on baseline bloodwork.
  4. For R/R CLL arms - Must have active CLL/SLL disease requiring treatment per iwCLL 2018 criteria.
  5. For R/R CLL arms - Received at least 2 prior lines of systemic anti-neoplastic therapy including a Bruton's tyrosine kinase (BTK) inhibitor.
  6. For all RS arms - Have tumor biopsy-proven CD20+ Diffuse large B-cell Lymphoma (DLBCL) and a clinical history of CLL/SLL.
  7. For all RS arms - Must have measurable disease by fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT) or magnetic resonance imaging (MRI) scan.
  8. For all RS arms - Must provide mandatory formalin-fixed, paraffin-embedded (FFPE) tumor biopsy sample.
  9. Life expectancy >3 months on standard of care (SOC).
  10. For RS - monotherapy arm: Deemed as ineligible for chemoimmunotherapy at investigator's discretion or participant who refuses to receive intensive chemotherapy

  11. For RS - lenalidomide combination therapy arm

    • Deemed as ineligible for chemoimmunotherapy at the investigator's discretion, or participant who refuses to receive intensive chemotherapy.
    • Eligible for treatment with lenalidomide.
    • Must be willing to use contraception and adhere to the Lenalidomide Pregnancy Risk Minimization Plan

  12. For RS - R-CHOP combination Therapy Arm -

    • Eligible for treatment with R-CHOP.
  13. For R/R CLL - venetoclax combination Therapy arm - after receiving at least 1 prior line of systemic antineoplastic therapy.

Exclusion

  1. Received prior treatment with a CD3×CD20 bispecific antibody.
  2. Received any prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation.
  3. Received (CAR) T-cell therapy within 100 days or an investigational drug within 4 weeks, prior to first dose of epcoritamab.
  4. Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.
  5. Received vaccination with live vaccines within 28 days.
  6. Clinically significant cardiac disease.
  7. Known current malignancy other than inclusion diagnosis.
  8. Has had major surgery within 4 weeks.
  9. Active hepatitis B virus or active hepatitis C.
  10. Known history of HIV.
  11. For R/R CLL arms - Any history of RS or evidence indicating a potential Richter's transformation.
  12. Received venetoclax within 24 months prior to beginning venetoclax ramp-up for this trial and progressed on treatment.
  13. For all RS arms - Diagnosis of Richter's syndrome not of the DLBCL subtype such as Hodgkin's lymphoma, prolymphocytic leukemia.
  14. RS - Lenalidomide Combination Therapy and RS Monotherapy Arms - received more than 2 prior lines of therapy for RS.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You have had treatment, but your cancer has come back.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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