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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXiangyang No.1 People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • autologous NK cell

    Combination product

    autologous NK cell

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: NK cellExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Refer to the 2014 version of Lugano standard

Time frame
up to 5 years of treatment

Secondary outcomes

1

CR

Refer to the 2014 version of Lugano standard

Time frame
up to 5 years of treatment
2

PR

Refer to the 2014 version of Lugano standard

Time frame
up to 5 years of treatment
3

SD

Refer to the 2014 version of Lugano standard

Time frame
up to 5 years of treatment
4

PD

Refer to the 2014 version of Lugano standard

Time frame
up to 5 years of treatment

Other outcomes

Sponsors and contacts

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Xiangyang No.1 People's Hospital

Lead sponsor

Qingdao Haier Biotechnology Co.,Ltd.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: