Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Treatment on this study includes eight XS005 cell infusions over an 16 week period.

Phase 1： dose escalation (3+3); Phase 2 : dose of recommended phase 2 dose(RP2D).

XS005 Cell Injection

Patients were given temozolomide on day 1 to day 5 of each cycle, 28 days per cycle, for a total of 4 cycles.

Temozolomide（TMZ）

Yulun Huang

Xuetao Li

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.

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.

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

Clinical Study of Evaluating the Safety and Initial Efficacy of XS005 Cell Injection Combined With Stupp Regimen for Adjuvant Chemotherapy in Subjects With Primary Glioblastoma

Changes of NK cells in CSF pre-and post- infusion and at each of the main follow-up time points.

Changes of cytokines (such as interleukin-6(IL-6), interferon-γ (IFN-γ) etc.) in CSF pre-and post- infusion and at each of the main follow-up time points.

DLT is defined as a toxic effect in the subject at any dose, cannot be reasonably attributed to the subject's underlying disease, other conditions, and/or concomitants, that the investigator determines to be related (including definitely, likely, or possibly) to the XS005 cell injection.

AE is defined as any adverse medical event within 4 months after the the first infusion of XS005.

MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.

PFS : defined as the time from the start of treatment until the onset of tumor progression or death from any cause;

Dushu Lake Hospital Affiliated to Soochow University

Apatinib

Angiogenesis Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide）

concurrent chemoradiotherapy（Temozolomide） maintenance therapy（Temozolomide）

concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide+apatinib）

These drugs are planned to inhibit the proliferation and metastasis of tumors.

Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced.

Wenmin Ying, Bachelor

Temozolomide (TMZ) is an oral chemotherapy drug. It is an alkylating agent used as a first-line treatment for glioblastoma. This methylation damages the DNA and triggers the death of tumor cells. According to the results of several clinical studies, TMZ synchronous plus radiotherapy and subsequent as adjuvant therapy can significantly improve the survival rate of newly diagnosed glioblastoma patients.

Glioma is the highest incidence of the central nervous system tumor. Surgical treatment is one of the most important therapeutic methods in patients with glioblastoma. But since malignant glioma is a highly invasive tumor, the rate of surgery failure is . So the postoperative therapy shall be accompanied by radiotherapy. Since 1998, the clinical application of Temozolomide(TMZ) has brought hope for malignant glioma patients with its definite curative effect. According to the results of several clinical studies, TMZ synchronous plus radiotherapy and subsequent as adjuvant therapy can significantly improve the survival rate of newly diagnosed GBM patients and break the survival limit of malignant glioma patients. Besides, antiangiogenic therapy is also a choice for the treatment of glioblastoma patients. Vascular endothelial growth factor receptors (VEGFRs) inhibitors block the new formation around the tumor and cut down the supply of oxygen, nutrients and metabolic waste, so that the tumor is hard to proliferate and metastases.

Temozolomide Plus Anti-angiogenesis Drugs and Radiotherapy as a Treatment for Glioblastoma

A Retrospective Clinical Study of Postoperative Concurrent Chemoradiotherapy Combined With Anti-angiogenic Drugs in the Treatment of Glioblastoma.

in this Survival Duration neither Progression nor death occurs in the subjects.

The average score of edema grading in patients before and after treatment was calculated separately.

To observe any adverse events that occurred during the clinical study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Natural Killer (NK) Cells (XS005) Injection Combined With Stupp Regimen for Adjuvant Chemotherapy in Subjects With Primary Glioblastoma(GBM)	NCT06147505	Glioblastoma GBM	XS005 Cell Inje... Temozolomide（TM...	18 Years - 70 Years	Dushu Lake Hospital Affiliated to Soochow University
Temozolomide Plus Anti-angiogenesis Drugs and Radiotherapy as a Treatment for Glioblastoma	NCT03567135	Glioblastoma	Apatinib Temozolomide（TM...	18 Years - 70 Years	Fuzhou General Hospital
Temozolomide Plus Anti-angiogenesis Drugs and Radiotherapy as a Treatment for Glioblastoma	NCT03567135	Glioblastoma	Apatinib Temozolomide（TM...	18 Years - 70 Years	Fuzhou General Hospital

Spots Global Cancer Trial Database for temozolomide（tmz）