This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell injection solution in adult subjects with relapsed/refractory CD19-positive B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Biological: CD 19-CAR T cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (3×10\^8 CAR+cells) ,dose 2 (6× 10\^8 CAR+cells).
Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (500-1000 mg/m² administered 3 days).
Eligible subjects will receive lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30-40 mg/m² administered 3 days).
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
Adverse Event
AE is defined as any adverse medical event from the date of leukapheresis to 12 months after QH103 infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versushost disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0
Time frame: 12months
Incidence of Dose-Limiting Toxicities (DLTs)
DLT was defined as QH103 Cells-related events with onset within first 28 days following infusion.
Time frame: First infusion date of QH103 cells to 28 days end cell infusion
Maximum tolerated dose (MTD)
MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.
Time frame: 28 days
PK-Tmax
Time to peak in CAR-T cell count in peripheral blood after infusion of QH103.
Time frame: 12 months
Pharmacodynamics: Peak level of cytokines in serum
The Changes from baseline of level cytokines and chemokines in peripheral blood after infusion of QH103
Time frame: 12 months
Overall Response Rate(ORR)
Defined as complete response plus partial response.
Time frame: 6 months
Overall Survival(OS)
Survival as estimated by Kaplan-Meier method. Death from any cause is considered as event for analysis.
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Time frame: 6 months&12 months
Progression-Free Survival(PFS)
Survival as estimated by Kaplan-Meier method. The length of time during and after the treatment of a disease is considered as event for analysis.
Time frame: 6 months
PK-Cmax
Peak concentration (Cmax) in the CAR-T cell count in peripheral blood after infusion of QH103.
Time frame: 12 months
PK-AUC
Area under the concentration-time curve of CAR-T cell count in peripheral blood after infusion of QH103 from 0 to 12 months
Time frame: 12 months
PK-Tlast
The final time point in CAR-T cell count in peripheral blood after infusion of QH103.
Time frame: 12 months
PK-Clast
The final point concentration (C last) in the CAR-T cell count in peripheral blood after infusion of QH103
Time frame: 12 months