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

Trial Status: Active

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.

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

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)
  • Positive test results for HTLV-1
  • Suspected active or latent tuberculosis

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Mayur Narkhede
Phone: 205-801-8415

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: April Johnson
Phone: 949-653-2959ext118
San Francisco
University of California San Francisco
Status: APPROVED
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Lorenzo Falchi
Phone: 646-449-1994

The following regimens will be investigated:

- Arm 1: epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and

prednisone (R-CHOP) in subjects with previously untreated diffuse large B-cell lymphoma

(DLBCL)

- Arm 2: epcoritamab + rituximab and lenalidomide (R2) in subjects with

relapsed/refractory (R/R) follicular lymphoma (FL)

- Arm 3: epcoritamab + rituximab and bendamustine (BR) in subjects with previously

untreated FL

- Arm 4: epcoritamab + rituximab, cisplatin, cytarabine, and dexamethasone (R-DHAX/C) in

subjects with R/R DLBCL eligible for autologous stem cell transplant (ASCT)

- Arm 5: epcoritamab + gemcitabine and oxaliplatin (GemOx) in subjects with R/R DLBCL

ineligible for ASCT due to age, performance status (PS), or comorbidity

For each arm, there are 2 parts: Part 1 (dose escalation) and Part 2 (expansion). Within each

arm, subjects can only participate in one part.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Genmab

  • Primary ID GCT3013-02
  • Secondary IDs NCI-2021-00220
  • Clinicaltrials.gov ID NCT04663347