Clinical Trial Goal
To find out if epcoritamab is safe and works well to treat B-cell lymphoma that is refractory to treatments with CAR T cells
You may be able to join this trial if you:
- Are 18 years old or older
- Have one of the following that did not fully respond to treatment with CAR T cells:
- Diffuse large B-cell lymphoma (DLBCL)
- Primary mediastinal large b-cell lymphoma (PMLBCL)
- Transformations of indolent (slow growing) B-cell lymphomas
- Have been treated with one of the following CD19 CAR T-cell therapies:
- Axicabtagene ciloleucel (axi-cel)
- Tisagenlecleucel (tisa-cel)
- Lisocabtagene maraleucel (liso-cel)
- Have what doctors describe as a partial response to treatment. Your doctor can tell you this
- Have not been treated with a bispecific antibody drug targeting CD20 and CD3 receptors like epcoritamab. Your doctor can tell you this
- Do not have ongoing neurotoxicity or cytokine release syndrome (CRS) after the CAR T-cell therapy. Your doctor can tell you this
- Have not had grade 4 CRS or neurotoxicity after the CAR T-cell therapy. Your doctor can tell you this
- Do not have lymphoma in your brain or spinal cord
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Epcoritamab is a bispecific antibody that targets CD3 and CD20 on certain cells.
CAR stands for chimeric antigen receptors and T stands for T cells, a type of immune cell. This treatment helps your own immune system find and destroy cancer cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
CAR stands for chimeric antigen receptors and T stands for T cells, a type of immune cell. This treatment helps your own immune system find and destroy cancer cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 – Epcoritamab
- Group 2 – Standard observation
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
You'll get treatment in cycles that last 1 month: In each cycle, you'll get:
- Epcoritamab - Group 1 only - A shot given under your skin 1 - 4 times
You may continue treatment for as up to 1 year. You’ll have biopsies and scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 5 years.
The Food and Drug Administration (FDA) has approved epcoritamab to treat follicular lymphoma. Using it in this way to treat lymphoma that is partially responsive to treatment with CAR T cells is new and unproven.
Watch a video about CAR T-Cell Therapy
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Locations
Sponsors
collaborator: National Cancer Institute (NCI), lead: Academic and Community Cancer Research United
