This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LUCAR-20SP, an allogenic CAR-T cell therapy in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. Patients who meet the eligibility criteria will receive LUCAR-20SP infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment and follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Prior to infusion of the LUCAR-20SP, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Beijing GoBroad Boren Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, China
RECRUITINGDose-limiting toxicity (DLT) rate
DLT refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Recommended Phase 2 Dose (RP2D) regimen finding
RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR transgene levels in peripheral blood after LUCAR-20SP infusion. CAR positive T cells levels in bone marrow after LUCAR-20SP infusion.
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Pharmacokinetics in bone marrow
CAR positive T cells levels in bone marrow after LUCAR-20SP infusion. CAR transgene levels in bone marrow after LUCAR-20SP infusion.
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Objective Response Rate (ORR) after administration
ORR is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment via LUCAR-20SP cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per the Lugano Classification for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma (Lugano 2014)
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Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Time to Response (TTR) after administration
TTR is defined as the time from the date of first infusion of LUCAR-20SP to the date of the first response evaluation of the subject who has met all criteria for PR or better.
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Duration of Remission (DoR) after administration
DoR is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to Lugano 2014) of the responders (who achieve PR or better response).
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Progression-free Survival (PFS) after administration
PFS is defined as the time from the date of first infusion of the LUCAR-20SP to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first.
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
Overall Survival (OS) after administration
OS is defined as the time from the date of first infusion of LUCAR-20SP to death of the subject.
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
Incidence of anti-LUCAR-20SP antibody
The incidence of anti-LUCAR-20SP antibody in patients who received LUCAR-20SP infusion.
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)