This is a prospective, single-arm, open-label, exploratory clinical study of LCAR-HL30 in adult subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma.
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LCAR-HL30, a chimeric antigen receptor(CAR)-T cell therapy in subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma. Patients who meet the eligibility criteria will receive LCAR-HL30 infusion. The study will include the following sequential stages: screening, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment and follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Prior to infusion of the LCAR-HL30, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGIncidence, 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 LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR positive T cells levels in peripheral blood after LCAR-HL30 infusion.
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR transgene levels in peripheral blood after LCAR-HL30 infusion.
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Pharmacokinetics in bone marrow
CAR positive T cells levels in bone marrow after LCAR-HL30 infusion.
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Pharmacokinetics in bone marrow
CAR transgene levels in bone marrow after LCAR-HL30 infusion.
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 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 LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
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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 LCAR-HL30 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).
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Time to Response (TTR) after administration
TTR is defined as the time from the date of first infusion of LCAR-HL30 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 LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 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 LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Progression-free Survival (PFS) after administration
PFS is defined as the time from the date of first infusion of the LCAR-HL30 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 LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Overall Survival (OS) after administration
OS is defined as the time from the date of first infusion of LCAR-HL30 to death of the subject.
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Incidence of anti-LCAR-HL30 antibody
The incidence of anti-LCAR-HL30 antibody in patients who received LCAR-HL30 infusion.
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)