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

B-cell Lymphoma Refractory Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05909098
• Other study ID #: Xiangyang1PH
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2023
• Est. completion date: November 30, 2028

Study information

• Verified date: June 2023
• Source: Xiangyang No.1 People's Hospital
• Contact: Jiwu He
• Phone: +86 07103122615
• Email: xzyxhgx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: November 30, 2028
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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. -

Related Conditions & MeSH terms

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

Intervention

Combination Product:
• autologous NK cell
autologous NK cell

Locations

Country	Name	City	State
China	EC of Xiangyang No.1 People's Hospital Hubei University of Medicine	Hubei	Xiangyang

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

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