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

NCT ID: NCT05909098

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2028-11-30

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.

Conditions

NK Cell; B-cell Lymphoma Recurrent; B-cell Lymphoma Refractory

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NK cell

autologous NK cell adjuvant therapy

Group Type: EXPERIMENTAL

autologous NK cell

Intervention Type: COMBINATION_PRODUCT

autologous NK cell

Interventions

autologous NK cell

autologous NK cell

Intervention Type: COMBINATION_PRODUCT

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qingdao Haier Biotechnology Co.,Ltd.

UNKNOWN

Sponsor Role: collaborator

Xiangyang No.1 People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bin Pei

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bin Pei

Role: PRINCIPAL_INVESTIGATOR

Xiangyang No.1 People's Hospital

Locations

EC of Xiangyang No.1 People's Hospital Hubei University of Medicine

Hubei, Xiangyang, China

Countries

China

Central Contacts

Jiwu He

Role: CONTACT

xzyxhgx@163.com

+86 07103122615

Facility Contacts

Jiwu He

Role: primary

xzyxhgx@163.com

+86 07103122615

Other Identifiers

Xiangyang1PH

Identifier Type: -

Identifier Source: org_study_id