drugset / Trial / NCT05909098
Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed/Refractory Non-Hodgkin's B-cell Lymphoma
Phase 1/2
Not yet recruiting
33 enrolled
Xiangyang No.1 People's Hospital
Qingdao Haier Biotechnology Co.,Ltd. · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-07-01
- Primary completion
- 2026-12-30
- Completion
- 2028-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | autologous NK cell | Cell therapy | 2e+09 cells | — |
| Subject | autologous NK cell | Cell therapy | 4e+09 cells | — |