A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma
his is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39P in the patient ≥ 18 years of age with relapsed or refractory B-cell non-Hodgkin lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LUCAR-G39P injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
LUCAR-G39P cells product Prior to infusion of the LUCAR-G39P, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjin, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Beijing Gobroad Hosptial
Beijing, China
Incidence, severity and type of TEAEs
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Through study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39P infusion
Time frame: ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
Pharmacokinetics in bone marrow
CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39P infusion.
Time frame: ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
The recommended Phase II dose (RP2D) for this cell therapy
RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion
Time frame: Within 30 days after LUCAR-G39P infusion
Overall Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LUCAR-G39P cell infusion
Time frame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Progression-free survival (PFS)
rogression Free Survival (PFS) is defined as the time from the date of first infusion of the LUCAR-G39P to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first
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Time frame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first infusion of LUCAR-G39P to death of the subject
Time frame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Time to Response (TTR)
Time to Response (TTR) is defined as the time from the date of first infusion of LUCAR-G39P to the date of the first response evaluation of the subject who has met all criteria for CR or PR
Time frame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Duration of Response (DoR)
Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders.
Time frame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Immunogenicity assessment of LUCAR-G39P cells
The incidence of Anti- LUCAR-G39P antibody in patients who received LUCAR-G39P cells infusion
Time frame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)