Epcoritamab-CAR T Cells for Large B-cell Lymphomas
NCT Number: NCT06458439
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lymphoma, Non-Hodgkin|Relapsed Diffuse Large B Cell Lymphoma|Refractory Diffuse Large B-cell Lymphoma|High-grade B-cell Lymphoma|Transformed Indolent Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
Interventions: DRUG: Epcoritamab
Sponsor: Abramson Cancer Center at Penn Medicine
Collaborators: Genmab
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 31
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-12
Locations: Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
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.

Primary Outcome Measures: Occurrence of CAR T cell infusion among subjects who receive epcoritamab and undergo leukapheresis, Whether participants receive CAR T-cell infusion (yes/no), Start of epcoritamab to CAR T-cell infusion
Secondary Outcome Measures: 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, Day 1 of epcoritamab until CAR T cell infusion|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, Day 1 of epcoritamab to completion of 2 cycles of epcoritamab|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, CAR T cell infusion through day 28 visit after CAR T-cells|Day 28 visit response rates post CAR T cell infusion, Overall response rate as well as complete response rate after CAR T-cells, Day 28 visit after CAR T cell infusion|Progression-free survival, duration of response, and overall survival for those subjects achieving complete response at Day 28 visit post CAR T cell infusion, Duration of response from day 28 visit after CAR T-cells, progression-free survival and overall survival from CAR T-cell infusion, CAR T cell infusion until last follow-up or death|Incidence and severity of AEs, SAEs from day 28 visit after CAR T-cell infusion until epcoritamab discontinuation, Assessment of toxicity via incidence and severity of AEs and SAEs via CTCAE v5, Day 28 visit after CAR T-cell infusion until epcoritamab discontinuation up to 12 cycles of epcoritamab|Responses at 3 and 6 months after CAR T-cell infusion for subjects who receive epcoritamab after CAR T-cells, Best overall response rate, overall response rate, and complete response rate at 3 and 6 months after CAR T cell infusion for subjects who receive epcoritamab after CAR T-cells, 3 and 6 months after CAR T-cell infusion|Duration of response, progression-free survival and overall survival from time of CAR T-cell infusion for subjects who receive post CAR T-cell epcoritamab infusions, Duration of response from first response after CAR T-cell infusion, progression-free survival and overall survival from CAR T-cell infusion, From CAR T-cell infusion until date of last follow-up or date of death due to any cause, whichever comes first, assessed up to 5 years from last dose of epcoritamab