Natural Killer (NK) Cells (XS005) Injection Combined With Stupp Regimen for Adjuvant Chemotherapy in Subjects With Primary Glioblastoma(GBM)

General Information

Summary

The main objective of this clinical study is to evaluate the safety of XS005 cell which contains Natural Killer (NK) cells and culture-expanded injection; to determine the maximum tolerated dose . Furthermore, initial efficacy will be examined.

Description

Treatment on this study includes eight XS005 cell infusions over an 16 week period. The study will evaluate the safety, feasibility and maximum tolerated dose (MTD) of XS005 cell using a 3+3 study design . The total study duration will be 2 years.

Clinical trials phase

Phases 1/2

Start date (estimated)

2023-10-29

End date (estimated)

2025-12-29

Clinical feature

Label	glioblastoma
Link	http://purl.obolibrary.org/obo/DOID_3068
Description	A malignant astrocytoma characterized by the presence of small areas of necrotizing tissue that is surrounded by anaplastic cells as well as the presence of hyperplastic blood vessels, and that has_material_basis_in abnormally proliferating cells derives_from multiple cell types including astrocytes and oligondroctyes.

Administrative Information

NCT number

NCT06147505

ICTRP weblink

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06147505

Other study identifiers

Name	XS-005

Source weblink

https://clinicaltrials.gov/study/NCT06147505

Public contact

Email	huangyulun@suda.edu.cn
Public email	huangyulun@suda.edu.cn
First name	Yulun
Last name	Huang
Phone	+86 130 1388 9432

Cells

Which differentiated cell type is used

Label	natural killer cell
Link	http://purl.obolibrary.org/obo/CL_0000623
Description	A lymphocyte that can spontaneously kill a variety of target cells without prior antigenic activation via germline encoded activation receptors and also regulate immune responses via cytokine release and direct contact with other cells.

Recruitment

Recruitment Status

Recruiting

Estimated number of participants