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

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
autologous NK cell
Sponsored by
Xiangyang No.1 People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NK Cell

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NK cell

Arm Description

autologous NK cell adjuvant therapy

Outcomes

Primary Outcome Measures

ORR
Refer to the 2014 version of Lugano standard

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2023
Last Updated
June 19, 2023
Sponsor
Xiangyang No.1 People's Hospital
Collaborators
Qingdao Haier Biotechnology Co.,Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05909098
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
November 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xiangyang No.1 People's Hospital
Collaborators
Qingdao Haier Biotechnology Co.,Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NK Cell, B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NK cell
Arm Type
Experimental
Arm Description
autologous NK cell adjuvant therapy
Intervention Type
Combination Product
Intervention Name(s)
autologous NK cell
Intervention Description
autologous NK cell
Primary Outcome Measure Information:
Title
ORR
Description
Refer to the 2014 version of Lugano standard
Time Frame
up to 5 years of treatment
Secondary Outcome Measure Information:
Title
CR
Description
Refer to the 2014 version of Lugano standard
Time Frame
up to 5 years of treatment
Title
PR
Description
Refer to the 2014 version of Lugano standard
Time Frame
up to 5 years of treatment
Title
SD
Description
Refer to the 2014 version of Lugano standard
Time Frame
up to 5 years of treatment
Title
PD
Description
Refer to the 2014 version of Lugano standard
Time Frame
up to 5 years of treatment
Title
CBR
Description
Refer to the 2014 version of Lugano standard
Time Frame
up to 5 years of treatment
Title
PFS
Description
Refer to the 2014 version of Lugano standard
Time Frame
up to 5 years of treatment
Title
DOR
Description
Refer to the 2014 version of Lugano standard
Time Frame
up to 5 years of treatment
Title
OS
Description
Refer to the 2014 version of Lugano standard
Time Frame
up to 5 years of treatment
Title
ECOG
Description
ECOG score Zubrod-ECOG-WHO (ZPS, 5-point scale)
Time Frame
up to 5 years of treatment
Title
EORTC QLQ-C30
Description
EORTC:The European O-rganization for Reasearch and Treatment of Cancer
Time Frame
up to 5 years of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiwu He
Phone
+86 07103122615
Email
xzyxhgx@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Pei
Organizational Affiliation
Xiangyang No.1 People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
EC of Xiangyang No.1 People's Hospital Hubei University of Medicine
City
Hubei
State/Province
Xiangyang
ZIP/Postal Code
441000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiwu He
Phone
+86 07103122615
Email
xzyxhgx@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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