Open Actively Recruiting

Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia

About

Brief Summary

The trial is an open-label, multi-center satefy and efficacy trial of epcoritamab in relapsed/refractory chronic lymphocytic leukemia (R/R CLL). 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
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria

  • Subject must sign an ICF, prior to any screening procedures.
  • Must have active CLL disease that needs treatment per iwCLL2018
  • R/R CLL after receiving at least 2 prior lines of systemic antineoplastic therapy, including treatment with (or intolerance of) a BTK inhibitor
  • Has Measurable Disease with ≥5 × 109/L (5,000/μL) B lymphocytes in peripheral blood or Presence of measurable lymphadenopathy and/or organomegaly
  • ECOG performance status score of 0 or 1
  • Screening flow cytometry evidence of CD20 positivity
  • Has laboratory parameters as follows: a. 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
  • Must take prophylaxis for TLS
  • A woman must be either not of childbearing potential or of childbearing potential and practicing a highly effective method of birth control, and must have a negative serum beta-human chorionic gonadotropin (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.

Exclusion Criteria

  • Transformation of CLL to aggressive non-Hodgkin lymphoma
  • 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 or medical device within 4 weeks, before the first dose.
  • Received chemotherapy or radiation therapy within 2 weeks of the first dose of epcoritamab.
  • Has autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.
  • Has uncontrolled intercurrent illness.
  • Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
  • Primary central nervous system (CNS) lymphoma or known CNS involvement at screening.
  • Known past or current malignancy other than inclusion diagnosis
  • Subject has suspected allergies, hypersensitivity, or intolerance to epcoritamab or its excipients.
  • Subject is unable to tolerate uric acid reducing medications
  • Has had major surgery within 3 weeks before screening or will not have fully recovered from surgery, or has major surgery planned during the time the subject is expected to participate in the trial (or within 4 weeks after the last dose of epcoritamab).Known history/positive serology for hepatitis B.
  • Known medical history or ongoing hepatitis C infection that has not been cured.
  • HIV tested positive at screening.
  • Is a woman who is pregnant or breast-feeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epicoritamab.
  • Is a man who plans to father a child while enrolled in this trial or within 12 months after the last dose of epicoritamab.

Join this Trial

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Study Stats
Protocol No.
20-002259
Category
Hematology-Oncology
Oncology
Principal Investigator
Contact
NICOLE SOWDEN
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04623541
For detailed technical eligibility, visit ClinicalTrials.gov.