A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
NCT Number: NCT06494371
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hodgkin's Lymphoma|Anaplastic Large Cell Lymphoma
Interventions: BIOLOGICAL: LCAR-HL30 cells
Sponsor: Ruijin Hospital
Collaborators: Nanjing Legend Biotech Co.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2028-08
Locations: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Summary:
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.

Primary Outcome Measures: 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., 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., 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., 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., 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., 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., Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Secondary Outcome Measures: 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)., 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., 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)., 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., 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., 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., Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)