Clinical trial NCT05909098: Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed/Refractory Non-Hodgkin's B-cell Lymphoma
Official title: Xiangyang No.1 People's Hospital, Hubei University of Medicine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: NK Cell
B-cell Lymphoma Recurrent
B-cell Lymphoma Refractory
Lead sponsor: Xiangyang No.1 People's Hospital
Sponsor class: OTHER
Collaborators: name: Qingdao Haier Biotechnology Co.,Ltd.
First posted: 2023-06-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with age 15 years to 80 years, with life expectancy greater than 6 months.
2. 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.
3. First diagnosed relapsed/refractory non-Hodgkin's B-cell lymphoma.
4. ECOG scores were 0 to 2
5. Presence of at least one CT measurable lesion locus with a maximum transverse diameter of ≥1.5 cm before inclusion in the study.
6. 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.
7. For men of childbearing potential, inform and require the use of an effective barrier contraceptive method.
8. Volunteer to participate in the trial and sign the informed consent form.

Exclusion Criteria:

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

Primary outcomes:
measure: ORR
timeFrame: up to 5 years of treatment
Secondary outcomes:
measure: CR
timeFrame: up to 5 years of treatment
measure: PR
timeFrame: up to 5 years of treatment
measure: SD
timeFrame: up to 5 years of treatment
measure: PD
timeFrame: up to 5 years of treatment
measure: CBR
timeFrame: up to 5 years of treatment
measure: PFS
timeFrame: up to 5 years of treatment
measure: DOR
timeFrame: up to 5 years of treatment
measure: OS
timeFrame: up to 5 years of treatment
measure: ECOG
timeFrame: up to 5 years of treatment
measure: EORTC QLQ-C30
timeFrame: up to 5 years of treatment
Other outcomes:
Locations:
city: Hubei
country: China
facility: EC of Xiangyang No.1 People's Hospital Hubei University of Medicine
state: Xiangyang
Study officials:
affiliation: Xiangyang No.1 People's Hospital
name: Bin Pei
role: PRINCIPAL_INVESTIGATOR
References: