Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome (EPCORE™ CLL-1)

This is an interventional treatment trial for Relapsed/Refractory Chronic Lymphocytic Leukemia focused on measuring DuoBody®, Bispecific antibodies, Anti-CD3, Anti-CD20 Read More

Key Inclusion Criteria

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

Key Exclusion Criteria

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.