NCT06693973

An Early Clinical Study Evaluating the Safety and Efficacy of AcNK-Sup003 Cell Injection in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• B-cell Non-Hodgkin Lymphoma (B-NHL)

Interventions

Type	Name	Description
DRUG	AcNK-Sup003 cell injection solution	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.

Timeline

• Start date: 2023-12-27
• Primary completion: 2026-01-13
• Completion: 2026-01-13
• First posted: 2024-11-19
• Last updated: 2024-11-19

Locations

1 site across 1 country: China