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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    130
  • sponsor
    Genmab
Updated on 27 January 2021

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.

Description

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.

Details
Condition Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, Lymphoma, Non-Hodgkin's Lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma
Treatment gemcitabine and oxaliplatin, Epcoritamab, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, rituximab and lenalidomide, rituximab and bendamustine, rituximab, cisplatin, cytarabine, and dexamethasone
Clinical Study IdentifierNCT04663347
SponsorGenmab
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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