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

NCT05909098 | Not Yet Recruiting Phase 1

• 1 other identifier: Xiangyang1PH
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• ORR

  Refer to the 2014 version of Lugano standard

  up to 5 years of treatment

Secondary Outcomes (10)

• CR

  up to 5 years of treatment

• PR

  up to 5 years of treatment

• SD

  up to 5 years of treatment

• PD

  up to 5 years of treatment

• CBR

  up to 5 years of treatment

Study Arms (1)

NK cell

EXPERIMENTAL

autologous NK cell adjuvant therapy

Combination Product: autologous NK cell

Interventions

autologous NK cell COMBINATION_PRODUCT

autologous NK cell

NK cell

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Xiangyang No.1 People's Hospital: lead
• Qingdao Haier Biotechnology Co.,Ltd.: collaborator

Study Sites (1)

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

Hubei, Xiangyang, 441000, China

Location

Study Officials

• Bin Pei

  Xiangyang No.1 People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiwu He

CONTACT

+86 07103122615; xzyxhgx@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): November 30, 2028
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)