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Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

About

Brief Summary

The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as:

- Monotherapy, or - Combination therapy: - epcoritamab + venetoclax - epcoritamab + lenalidomide - epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone). The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter's Syndrome (RS). Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase.
Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Key Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
  • Evidence of CD20 positivity in a sample representative of the disease at Screening.
  • Acceptable hematology parameters and organ function based on baseline bloodwork.
  • For R/R CLL arms - Must have active CLL/SLL disease requiring treatment per iwCLL 2018 criteria.
  • For R/R CLL arms - Received at least 2 prior lines of systemic anti-neoplastic therapy including a Bruton's tyrosine kinase (BTK) inhibitor.
  • For all RS arms - Have tumor biopsy-proven CD20+ Diffuse large B-cell Lymphoma (DLBCL) and a clinical history of CLL/SLL.
  • 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.
  • For all RS arms - Must provide mandatory formalin-fixed, paraffin-embedded (FFPE) tumor biopsy sample.
  • Life expectancy >3 months on standard of care (SOC).
  • For RS - monotherapy arm: Deemed as ineligible for chemoimmunotherapy at investigator's discretion or participant who refuses to receive intensive chemotherapy
  • 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
  • For RS - R-CHOP combination Therapy Arm -
    • Eligible for treatment with R-CHOP.
  • For R/R CLL - venetoclax combination Therapy arm - after receiving at least 1 prior line of systemic antineoplastic therapy.

Key Exclusion Criteria

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

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Study Stats
Protocol No.
20-002259
Category
Leukemia
Contact
NICOLE SOWDEN
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04623541
For detailed technical eligibility, visit ClinicalTrials.gov.