Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

The trial is an open-label, multi-center safety and efficacy trial of epcoritamab in relapsed/refractory chronic lymphocytic leukemia (R/R CLL) and Ritcher's Syndrome (RS). The trial consists of two parts, a dose escalation phase (phase Ib) and an expansion phase (phase II).

Official Title

A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

Details

The purpose of the 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 in patients with R/R CLL. In the expansion phase, additional patients will be treated with epcoritamab at the RP2D and the purpose is to assess and evaluate the preliminary efficacy, safety and tolerability profiles of epcoritamab at the RP2D for R/R CLL and RS.

Keywords

Relapsed/Refractory Chronic Lymphocytic Leukemia Richter's Syndrome DuoBody® Monoclonal antibodies Anti-CD3 Anti-CD20 Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Syndrome Epcoritamab Epcoritamab in R/R CLL Epcoritamab in RS

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Subject must sign an ICF and be at least 18 years of age
  2. ECOG performance status score of 0, 1 or 2
  3. Screening evidence of CD20 positivity
  4. Has laboratory parameters - HBG-≥9.0 g/dL; ANC-≥1.0 x 109/L; Platelets-≥30 x 109/L
  5. Received a cumulative dose of corticosteroids less than the equivalent of 250 mg of prednisone within the 2-week period before the first dose
  6. Availability of fresh bone marrow material
  7. A woman must not be of childbearing potential and practicing a highly effective method of birth control, with a negative serum beta-hCG and urine pregnancy test at screening.
  8. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control.
  9. For R/R CLL Cohort - Must have active CLL disease requiring treatment per iwCLL2018
  10. . For R/R CLL Cohort - received at least 2 prior lines of systemic anti-neoplastic therapy anti-neoplastic therapy including a BTK inhibitor
  11. . For R/R CLL Cohort - Measurable Disease ≥5 × 109/L (5,000/μL) B lymphocytes in peripheral blood or Presence of measurable lymphadenopathy and/or organomegaly
  12. . For RS Cohort - Documented clinical history transformation to diffuse large B cell lymphoma (DLBCL)
  13. . For RS Cohort - Not eligible for chemoimmunotherapy
  14. . For RS Cohort - must have detectable disease by PET scan and measurable by CT scan or MRI

You CAN'T join if...

  1. Received prior treatment with a CD3 × CD20 bispecific antibody.
  2. Received any prior allogeneic HSCT or solid organ transplantation.
  3. Received treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or toxin-conjugated antibody or CAR T-cell therapy or investigational drug within 2 weeks.
  4. Received chemotherapy or radiation therapy within 2 weeks of the first dose of epcoritamab.
  5. Concomitant disease requiring permanent or high-dose immunosuppressive therapy.
  6. Received vaccination with live vaccines within 28 days prior to the first dose of epcoritamab.
  7. Clinically significant cardiac disease
  8. Major surgery within 4 weeks
  9. Hepatitis B or C seropositivity (unless clearly due to vaccination)
  10. . History of human immunodeficiency virus (HIV)
  11. . Unable or unwilling to comply with contraceptive requirements during treatment and for 12 months after last dose of of epcoritamab.
  12. . For R/R CLL Cohort - Any history of RS or evidence indicating a potential Richter's transformation.
  13. . For RS Cohort - Transformation of CLL to Hodgkin variant of RS
  14. . For RS Cohort - Diagnosis of Richter's syndrome not of the DLBCL subtype such as Hodgkin's lymphoma, prolymphocytic leukemia.
  15. . For RS Cohort - Subject received autologous HSCT within 3 months prior to the first dose of epcoritamab.
  16. . For RS Cohort - Subject received more than 1 prior line 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
  • Fred Hutchinson Cancer Research Center accepting new patients
    Seattle Washington 98109 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genmab
ID
NCT04623541
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 102 study participants
Last Updated