RecruitingEarly Phase 1NCT06693973

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


Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

13 participants

Start Date

Dec 27, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell therapy called AcNK-Sup003 — a type of natural killer (NK) cell infusion — in patients with relapsed or treatment-resistant B-cell non-Hodgkin's lymphoma, a type of blood cancer. NK cells are immune cells that can naturally recognize and kill cancer cells, and this therapy uses specially prepared NK cells to boost that ability. **You may be eligible if...** - You are 18 or older with an expected survival of at least 3 months - Your lymphoma has been confirmed by biopsy and is CD20-positive and has relapsed or stopped responding to treatment - You have received at least two prior treatment regimens (including a CD20-targeting drug and an anthracycline chemotherapy) and your cancer has progressed or not responded - You are in reasonably good physical condition and your organs are functioning adequately - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have active central nervous system involvement of lymphoma - You have a serious heart condition, severe infection, or uncontrolled other cancer - You are pregnant or breastfeeding - You cannot use effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcNK-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.


Locations(1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT06693973


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