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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
* 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
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGOccurrence of CAR T cell infusion among subjects who receive epcoritamab and undergo leukapheresis
Whether participants receive CAR T-cell infusion (yes/no)
Time frame: Start of epcoritamab to CAR T-cell infusion
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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