Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed/Refractory Non-Hodgkin's B-cell Lymphoma

This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.

Inclusion criteria

• Patients with age 15 years to 80 years, with life expectancy greater than 6 months.
• Pathologically confirmed non-Hodgkin B-cell lymphoma, confirmed by pathological examination at a grade A class 3 hospital or above, with pathology reported less than 3 years ago.
• First diagnosed relapsed/refractory non-Hodgkin's B-cell lymphoma.
• ECOG scores were 0 to 2
• Presence of at least one CT measurable lesion locus with a maximum transverse diameter of ≥1.5 cm before inclusion in the study.
• For women of childbearing potential, a negative pregnancy test must be confirmed before inclusion in the study and no intention to have children within 2 years.
• For men of childbearing potential, inform and require the use of an effective barrier contraceptive method.
• Volunteer to participate in the trial and sign the informed consent form.

Exclusion criteria

• Presence of bone marrow or/and central nervous system lymphoma.
• Patients with less than 5% peripheral blood NK cell percentage and pre-culture failure.
• Combined with other malignancies.
• Fever of non-disease-related origin within the last 5 days.
• Presence of uncontrollable bacterial, fungal, viral or other infections.
• Patients with HIV, TP positive
• Patients with severe cardiopulmonary, hepatic and renal, and cerebral dysfunction are present.
• Presence of other serious diseases that conflict with this protocol, such as autoimmune diseases, immunodeficiencies, severe thrombocytopenia, platelet dysfunction syndrome, etc.
• Received any form of organ transplantation, including allogeneic stem cell transplantation.
• Presence of a serious psychiatric disorder.
• Inability to communicate normally and incapacitation make it difficult to assess the safety and effectiveness of treatment.
• Pregnant or lactating women.
• The researchers deemed unsuitable for participation in this study. -