A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39D, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39D 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-G39D 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
33
Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Oncology Department, The First Affiliated Hospital of USTC west district
Hefei, Anhui, China
RECRUITINGTianjin Cancer Hospital
Tianjin, China
RECRUITINGIncidence, severity and type of TEAEs (Treatment-emergent Adverse Events)
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-G39D infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39D infusion.
Time frame: Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1).
Pharmacokinetics in bone marrow
CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39D infusion.
Time frame: Through study completion , an average of 2 years after LUCAR-G39D 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-G39D 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-G39D cell infusion
Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
Progression-free survival (PFS)
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LUCAR-G39D to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first infusion of LUCAR-G39D to death of the subject
Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
Time to Response (TTR)
Time to Response (TTR) is defined as the time from the date of first infusion of LUCAR-G39D 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-G39D 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-G39D infusion (Day 1)
Immunogenicity assessment of LUCAR-G39D cells
The incidence of Anti- LUCAR-G39D antibody in patients who received LUCAR-G39D cells infusion
Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)