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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: B-cell Lymphoma Refractory; B-cell Lymphoma Recurrent; NK Cell
• Intervention / Treatment: Combination product: autologous NK cell

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.

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jiwu He; Phone Number: +86 07103122615; Email: xzyxhgx@163.com

Study Locations

• China
  • Xiangyang
    • Hubei, Xiangyang, China, 441000
      • EC of Xiangyang No.1 People's Hospital Hubei University of Medicine
      • Contact: Jiwu He; Phone Number: +86 07103122615; Email: xzyxhgx@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NK cell; autologous NK cell adjuvant therapy	Combination product: autologous NK cell; autologous NK cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Refer to the 2014 version of Lugano standard	up to 5 years of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CR	Refer to the 2014 version of Lugano standard	up to 5 years of treatment
PR	Refer to the 2014 version of Lugano standard	up to 5 years of treatment
SD	Refer to the 2014 version of Lugano standard	up to 5 years of treatment
PD	Refer to the 2014 version of Lugano standard	up to 5 years of treatment
CBR	Refer to the 2014 version of Lugano standard	up to 5 years of treatment
PFS	Refer to the 2014 version of Lugano standard	up to 5 years of treatment
DOR	Refer to the 2014 version of Lugano standard	up to 5 years of treatment
OS	Refer to the 2014 version of Lugano standard	up to 5 years of treatment
ECOG	ECOG score Zubrod-ECOG-WHO (ZPS, 5-point scale)	up to 5 years of treatment
EORTC QLQ-C30	EORTC:The European O-rganization for Reasearch and Treatment of Cancer	up to 5 years of treatment

Collaborators and Investigators

• Sponsor: Xiangyang No.1 People's Hospital
• Collaborators: Qingdao Haier Biotechnology Co.,Ltd.
• Investigators: Principal Investigator: Bin Pei, Xiangyang No.1 People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: Xiangyang1PH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No