Safety & Efficacy Study of Epcoritamab in Subjects With R/R Chronic Lymphocytic Leukemia and Richter's Syndrome
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).
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.
Join this Trial
- UCLA Santa Monica
- UCLA Westwood