The aim of this study is to evaluate the efficacy and safety of CAR T-cell therapy in combination with glofitamab for the treatment of relapsed/refractory large B-cell lymphoma with high-risk prognostic factors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Participants will receive CAR T-cell therapy via infusion on Day 0 (given as per treatment guidelines). Prior to CAR T-cell Therapy, participants will begin receiving lymphodepleting chemotherapy on Days -5 through -3 (given as per treatment guidelines).
Glofitamab is given intravenously at a dose of 2.5mg over 4 hours on Cycle 1 Day 8. Glofitamab is given intravenously at a dose of 10mg over 2 hours on Cycle 1 Day 15. Glofitamab is given intravenously at a dose of 30mg over 2 hours on Day 1 of Cycles 2-6 (as relevant).
Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.
Shanghai Ruijin Hospital
Shanghai, China
Complete Response (CR) Rate
CR rate is defined as the percentage of participants achieving CR per the Lugano Classification as determined by study investigators
Time frame: Up to 2 years
Objective Response Rate (ORR)
ORR is defined as the percentage of participants achieving either CR or partial response (PR) per the Lugano Classification as determined by study investigators
Time frame: Up to 2 years
Duration of Response (DoR)
DoR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression or death from any cause.
Time frame: Up to 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from leukapheresis to first documented progression or death from any cause.
Time frame: Up to 2 years
Overall Survival (OS)
OS is defined as the time from leukapheresis to death from any cause.
Time frame: Up to 2 years
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Assessed by CTCAE criteria v5 and ASTCT 2019 criteria for CRS/ICANS adverse events.
Time frame: Up to 2 years
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