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

About

Brief 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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase I/II

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

Key Inclusion Criteria

Subject must sign an ICF and be at least 18 years of age
ECOG performance status score of 0, 1 or 2
Screening evidence of CD20 positivity
Has laboratory parameters - HBG-≥9.0 g/dL; ANC-≥1.0 x 109/L; Platelets-≥30 x 109/L
Received a cumulative dose of corticosteroids less than the equivalent of 250 mg of prednisone within the 2-week period before the first dose
Availability of fresh bone marrow material
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.
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.
For R/R CLL Cohort - Must have active CLL disease requiring treatment per iwCLL2018
For R/R CLL Cohort - received at least 2 prior lines of systemic anti-neoplastic therapy anti-neoplastic therapy including a BTK inhibitor
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
For RS Cohort - Documented clinical history transformation to diffuse large B cell lymphoma (DLBCL)
For RS Cohort - Not eligible for chemoimmunotherapy
For RS Cohort - must have detectable disease by PET scan and measurable by CT scan or MRI

Key Exclusion Criteria

Received prior treatment with a CD3 × CD20 bispecific antibody.
Received any prior allogeneic HSCT or solid organ transplantation.
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.
Received chemotherapy or radiation therapy within 2 weeks of the first dose of epcoritamab.
Concomitant disease requiring permanent or high-dose immunosuppressive therapy.
Received vaccination with live vaccines within 28 days prior to the first dose of epcoritamab.
Clinically significant cardiac disease
Major surgery within 4 weeks
Hepatitis B or C seropositivity (unless clearly due to vaccination)
History of human immunodeficiency virus (HIV)
Unable or unwilling to comply with contraceptive requirements during treatment and for 12 months after last dose of of epcoritamab.
For R/R CLL Cohort - Any history of RS or evidence indicating a potential Richter's transformation.
For RS Cohort - Transformation of CLL to Hodgkin variant of RS
For RS Cohort - Diagnosis of Richter's syndrome not of the DLBCL subtype such as Hodgkin's lymphoma, prolymphocytic leukemia.
For RS Cohort - Subject received autologous HSCT within 3 months prior to the first dose of epcoritamab.
For RS Cohort - Subject received more than 1 prior line of therapy for RS.

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

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