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

Sponsor

Xiangyang No.1 People's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05909098

Collaborator

Qingdao Haier Biotechnology Co.,Ltd. (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
NK Cell B-cell Lymphoma Recurrent B-cell Lymphoma Refractory	Combination Product: autologous NK cell	Phase 1/Phase 2

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2026

Anticipated Study Completion Date :

Nov 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NK cell autologous NK cell adjuvant therapy	Combination Product: autologous NK cell autologous NK cell

Arm

Intervention/Treatment

Experimental: NK cell

autologous NK cell adjuvant therapy

Combination Product: autologous NK cell

autologous NK cell

Outcome Measures

Primary Outcome Measures

ORR [up to 5 years of treatment]
Refer to the 2014 version of Lugano standard

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EC of Xiangyang No.1 People's Hospital Hubei University of Medicine	Hubei	Xiangyang	China	441000

Sponsors and Collaborators

Xiangyang No.1 People's Hospital
Qingdao Haier Biotechnology Co.,Ltd.

Investigators

Principal Investigator: Bin Pei, Xiangyang No.1 People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bin Pei, Director, Xiangyang No.1 People's Hospital

ClinicalTrials.gov Identifier:

NCT05909098

Other Study ID Numbers:

Xiangyang1PH

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Lymphoma, B-Cell

Study Results

No Results Posted as of Jun 22, 2023