Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Official 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

Details

The purpose of the dose-escalation phase of the trial 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 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 patients with R/R CLL/SLL. Along with this, epcoritamab monotherapy, epcoritamab + lenalidomide and epcoritamab + R-CHOP will be evaluated in patients with RS to assess their efficacy, safety and tolerability profiles.

Keywords

Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome, DuoBody®, Bispecific antibodies, Anti-CD3, Anti-CD20, Leukemia, Lymphoid Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Syndrome, Prednisone, Cyclophosphamide, Rituximab, Doxorubicin, Vincristine, Lenalidomide, Venetoclax, Epcoritamab, rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, Epcoritamab in R/R CLL/SLL, Epcoritamab in RS, Epcoritamab + Venetoclax in R/R CLL/SLL, Epcoritamab + Lenalidomide in RS, Epcoritamab + R-CHOP in RS

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • David Geffen School of Medicine accepting new patients
    Los Angeles California 90095 United States
  • Cedars-Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genmab
Links
Sign up for this study
ID
NCT04623541
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 184 study participants
Last Updated