The purpose of this study is to determine whether AcNK-Sup003 cell injection is safe and effective in the treatment of elapsed or refractory B-cell non-Hodgkin's lymphoma.
The AcNK technology has successfully achieved the direct, covalent, and directional conjugation of intact antibodies which includes the Fc domain to the surface of NK cells via a one-step enzymatic reaction. This novel approach yields a non-genetically modified NK cell that is conjugated with dual-targeting antibodies, referred to as AcNK. Specifically, AcNK-Sup003 cells are cryopreserved NK cells that have been conjugated with bispecific antibodies target both CD20 and CD19. This clinical trial is an open-label, nonrandomized, investigator-initiated clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AcNK-Sup003 cell injection in patients with elapsed or refractory B-cell non-Hodgkin's lymphoma. The treatment cycle in this study is 28 days. A modified "3+3" design principle combined with accelerated titration is used, with three dose cohorts and one alternative dose cohort, each including 1 to 6 subjects (adjustments may be made based on the safety and efficacy results of enrolled subjects). The dose levels are: Dose Level 1: 3×10\^8 AcNK-Sup003 cells, Dose Level 2: 1×10\^9 AcNK-Sup003 cells, Dose Level 3: 3×10\^9 AcNK-Sup003 cells, Dose Level 4 (alternative dose): 9×10\^9 AcNK-Sup003 cells (with a flexibility range of ±20%). Treatments are administered up to three times from Day 0 to Day 14 of each cycle (recommended D0/D7/D14, the frequency of infusion per cycle may be adjusted by the investigator based on obtained PK data and the subject's actual situation).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
The AcNK technology has successfully achieved the direct, covalent, and directional conjugation of intact antibodies which includes the Fc domain to the surface of NK cells via a one-step enzymatic reaction. This novel approach yields a non-genetically modified NK cell that is conjugated with dual-targeting antibodies, referred to as AcNK. Specifically, AcNK-Sup003 cells are cryopreserved NK cells that have been conjugated with bispecific antibodies target both CD20 and CD19.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGDose-limiting toxicities (DLTs)
Time frame: up to Day 28 post-infusion
serious adverse events (SAEs)
The incidence, severity, and relationship to the study drug of all adverse events (AEs), including serious adverse events (SAEs). Adverse events would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Time frame: Through study completion, an average of 2 years
Maximum tolerated dose
Time frame: Through study completion, an average of 2 years
Objective response rate (ORR)
Clinical efficacy would be evaluated according to 2014 Lugano criteria.
Time frame: up to 1 year after treatment of AcNK-Sup003
Duration of response (DOR)
Clinical efficacy would be evaluated according to 2014 Lugano criteria.
Time frame: Through study completion, an average of 2 years
Progression-free survival (PFS)
PFS is defined as the interval between a subject's receipt of the first dose of AcNK-Sup003 cell infusion and the first assessment of disease progression or death.
Time frame: Through study completion, an average of 2 years
Overall survival (OS)
OS is defined as the interval between a subject's receipt of first AcNK-Sup003 cell infusion and death from any cause.
Time frame: Through study completion, an average of 2 years
Cmax
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cmax is the peak expansion value of NK cells in peripheral blood.
Time frame: up to Day 28 post-infusion
Tmax
Tmax is the time to maximum concentration in peripheral blood.
Time frame: up to Day 28 post-infusion
AUC (0- day 28)
Area under the curve (0- day 28) refers to the area under curve of NK cell expansion between infusion and day 28 post infusion. They all reflect the pharmacokinetics.
Time frame: up to Day 28 post-infusion