This study investigates the feasibility and efficacy of epcoritamab treatment before CAR T cells. This study also investigates if, when patients have residual lymphoma after CAR T cells, epcoritamab can help to effectively treat that lymphoma.
Age > 18 years
Subject must be able and willing to provide informed consent. In the case where the patient is incapacitated or not otherwise capable, a legally authorized representative (or decision maker when there is not an advanced directive in place) must be willing to provide informed consent on behalf of the patient.
Able to comply with the study protocol, in the investigator's judgment
ECOG PS of 0 - 2
Inability or unwillingness of the patient or legally authorized representative (or decision-maker when there is not an advanced directive in place) to provide informed consent.
Prior solid organ transplantation
Primary central nervous system (CNS) lymphoma or active secondary CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) or, if clinically indicated, by lumbar puncture.
Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone
Single group
Epcoritamab
Drug* C1D1: fixed priming dose of 0.16 mg subcutaneous injection * C1D8: fixed intermediate dose of 0.8 mg subcutaneous injection * C1D15 onward: fixed full dose of 48 mg subcutaneous injection
Occurrence of CAR T cell infusion among subjects who receive epcoritamab and undergo leukapheresis
Whether participants receive CAR T-cell infusion (yes/no)
Incidence and severity of AEs, SAEs from epcoritamab until CAR T cell infusion
Assessment of toxicity via incidence and severity of AEs and SAEs via CTCAE v5
Overall Response Rate after 2 cycles of Epcoritamab
Percentage of subjects who receive epcoritamab and have a CR or PR by Lugano 2014 criteria prior to CAR T-cells
Incidence and severity of AEs, SAEs after CAR T cell infusion through day 28 visit after CAR T-cell infusion
Assessment of toxicity via incidence and severity of AEs and SAEs via CTCAE v5
Day 28 visit response rates post CAR T cell infusion
Overall response rate as well as complete response rate after CAR T-cells
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Abramson Cancer Center at Penn Medicine
Lead sponsor
Genmab
Collaborator
