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

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 be tested either in

Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) as:

* Monotherapy, or
* Combination therapy:

* epcoritamab + venetoclax
* epcoritamab + pirtobrutinib

In Non-United States (US) Participants Only: Treatment-naïve (TN) high risk (HR) (CLL):

• epcoritamab + pirtobrutinib

Combination therapy for Richter's Syndrome (RS):

* epcoritamab + lenalidomide
* epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine \[Oncovin®\] and prednisone).

The study includes participants with R/R or TN HR CLL (non-US participants only)/small lymphocytic lymphoma (SLL) and participants with RS.

The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Participants with RS are only included in the expansion phase.

Epcoritamab will be injected subcutaneously (under the skin). Standard-of-care and combination treatments (venetoclax, pirtobrutinib, lenalidomide, and R-CHOP) will be given either orally (by mouth) or intravenously (in a vein).

Study details include:

* Study duration will be up to 5 years after the last participant's first treatment in the trial.
* The treatment duration for each participant will be between 12 months (1 year) and 24 months (2 years), depending upon the treatment arm assigned.
* The visit frequency will be either weekly, every other week, or monthly, depending upon the part of the study.

All participants will receive active drug; no one will be given placebo.

Conditions

• Relapsed/Refractory Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• Richter's Syndrome
• Treatment-naïve High Risk Chronic Lymphocytic Leukemia

Interventions

BIOLOGICAL

Epcoritamab

Epcoritamab will be administered subcutaneously in cycles of 28 days, (except Cycle 1 for high-dose cohorts = 35 days).

BIOLOGICAL

Epcoritamab

Epcoritamab will be administered subcutaneously in cycles of 21 days and 28 days.

DRUG

rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone

R-CHOP will be administered intravenously (prednisone may be administered orally) in cycles of 21 days.

DRUG

Venetoclax

Venetoclax tablets will be administered orally once daily during the 5-week ramp up period in cycles of 28 or 35 days each.

BIOLOGICAL

Epcoritamab

Epcoritamab will be administered subcutaneously in cycles of 28 days.

DRUG

Lenalidomide

Lenalidomide capsules will be administered once daily for 21 days in each cycle of 28 days.

BIOLOGICAL

Epcoritamab

Epcoritamab will be administered subcutaneously in cycles of 28 days.

DRUG

Pirtobrutinib

Pirtobrutinib tablets will be administered in cycles of 28 days.

BIOLOGICAL

Epcoritamab

Epcoritamab will be administered subcutaneously in cycles of 28 days.

Sponsors & Collaborators

• AbbVie

  collaborator INDUSTRY

• Eli Lilly and Company

  collaborator INDUSTRY

• Genmab

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-25

Primary Completion

2027-12-31

Completion

2028-02-29

FDA Drug

Yes

Countries

• United States
• Australia
• Belgium
• Czechia
• Denmark
• France
• Germany
• Israel
• Italy
• Netherlands
• Poland
• Spain

Study Locations