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Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma

About

Brief Summary

A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, PK, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab in combination with other standard of care (SOC) agents in subjects with B-NHL.

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
  • At least 18 years of age
  • Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on CT or MRI
  • ECOG PS score of 0, 1 or 2
  • Acceptable organ function at screening
  • CD20-positive NHL at most recent representative tumor biopsy
  • If of childbearing potential subject must practicing a highly effective method of birth control
  • A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control Arm 1:
  • Newly Diagnosed Documented DLBCL
  • DLBCL, NOS
  • "double-hit" or "triple-hit" DLBCL
  • FL Grade 3B Arm 2: R/R FL Arm 3: Newly diagnosed, previously untreated FL grade 1-3A Arm 4:
  • Documented DLBCL and eligible for HDT-ASCT
  • DLBCL, NOS
  • "double-hit" or "triple-hit" DLBCL
  • FL Grade 3B Arm 5:
  • Relapsed Documented DLBCL and ineligible for HDT-ASCT
  • DLBCL, NOS
  • "double-hit" or "triple-hit" DLBCL
  • FL Grade 3B Arm 6: Newly diagnosed, previously untreated FL grade 1-3A Arm 7:
  • FL Grade 1-3A
  • If PR or CR per Lugano criteria following first-line or second-line treatment with SOC regimen, and last dose of SOC within 6 months prior to enrollment.

Exclusion Criteria

  • Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
  • Any prior treatment with a bispecific antibody targeting CD3 and CD20.
  • Treatment with CAR-T therapy within 30 days prior to first dose of epcoritamab
  • Clinically significant cardiovascular disease
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
  • CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
  • Active positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
  • Known history of seropositivity of human immunodeficiency virus (HIV)
  • Suspected active or latent tuberculosis
  • Neuropathy > grade 1
  • Receiving immunostimulatory agent
  • Prior allogeneic HSCT

Join this Trial

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Study Stats
Protocol No.
20-001612
Category
Hematology-Oncology
Oncology
Principal Investigator
Contact
NICOLE SOWDEN
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04663347
For detailed technical eligibility, visit ClinicalTrials.gov.