Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT06238648
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Primary Mediastinal Large B-Cell Lymphoma
  • Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo PET/CT and/or CT
  • Epcoritamab — BIOLOGICAL
    Given SC
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Patient Observation — OTHER
    Undergo observation
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

This phase II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.

Key Dates

Start date
Jan 31, 2024
Status verified
Sep 2024
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (epcoritamab)
    Patients receive epcoritamab SC on days 1, 8, 15, and 22 of cycles 1-3, days 1 and 15 of cycles 4-9, and day 1 of cycles 10-12. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI at screening, undergo PET/CT and collection of blood samples throughout the trial, and undergo biopsy at screening and end of treatment. Patients may undergo CT or MRI during follow up.
  • Active Comparator: Arm B (observation)
    Patients undergo observation per standard care. Patients also undergo MRI at screening, undergo PET/CT and collection of blood samples throughout the trial, and undergo biopsy at screening and end of treatment. Patients may undergo CT or MRI during follow up.

Primary Outcome Measure

Objective status of complete response (CR) [ Time Frame: From randomization up to one year ]

Locations (6)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
ACCRU Operations
[email protected]
507-538-7448
Grzegorz S. Nowakowski (PRINCIPAL_INVESTIGATOR)
Siteman Cancer Center at Washington UniversitySt LouisMissouri63110
Dilan A. Patel
[email protected]
Dilan A. Patel (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Lori Leslie (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Miguel-Angel Perales
[email protected]
Miguel-Angel Perales (PRINCIPAL_INVESTIGATOR)
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Natalie S. Grover
[email protected]
Natalie S. Grover (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112
Allison Bock
[email protected]
Allison Bock (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Rochester· Rochester, MNSiteman Cancer Center at Washington University· St Louis, MOHackensack University Medical Center· Hackensack, NJMemorial Sloan Kettering Cancer Center· New York, NYUNC Lineberger Comprehensive Cancer Center· Chapel Hill, NCHuntsman Cancer Institute/University of Utah· Salt Lake City, UT

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