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Tests treatment safety and results for Glioblastoma (GBM)
Official title Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
ClinicalTrials.gov ID: NCT06757153
What this study is testing
What is NRG-103?
NRG-103 is an investigational medicine, being studied as a potential treatment for glioblastoma (gbm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if NRG103 works to treat recurrent GBM in adults. It will also learn about the safety of NRG103.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age≥18 years.
- Patients must have histologically or cytologically confirmed glioblastoma(WHO 2021).
- Patients have experienced recurrence (RANO 2.0) after previous anti-tumor treatments, including the recurrent tumor has been surgically removed and...
- The relevant adverse reactions from the previous treatment have been restored to ≤1 level(NCI-CTCAE v5.0).
- Karnofsky Performance Score≥70.
You likely can't join if
- Allergy to the components of the test drug and contrast agent.
- Unable to undergo imaging examinations required for the research.
- A history of cell therapy, gene therapy, or oncolytic virus therapy.
- Undergoing other clinical trials.
- A history of anti-tumor vaccines or other immunomodulatory drugs with 4 weeks.
- A history of other type of malignant tumors.
See the full eligibility criteria
- Age≥18 years.
- Patients must have histologically or cytologically confirmed glioblastoma(WHO 2021).
- Patients have experienced recurrence (RANO 2.0) after previous anti-tumor treatments, including the recurrent tumor has been surgically removed and an Ommaya reservoir has been placed inside the tumor cavity.
- The relevant adverse reactions from the previous treatment have been restored to ≤1 level(NCI-CTCAE v5.0).
- Karnofsky Performance Score≥70.
- Stable doses of dexamethasone during the week prior to inclusion.
- Adequate bone marrow reserve: White blood cell count\>2.0 × 109/L, neutrophil count\>1.0 × 109/L, platelet count\>100 × 109/L, international normalized ratio ≤1.5 times ULN, and activated partial thromboplastin time≤1.5...
- Normal heart, renal and liver function.
- Effective method of contraception for patients and their partners.
- Written informed consent.
- Allergy to the components of the test drug and contrast agent.
- Unable to undergo imaging examinations required for the research.
- A history of cell therapy, gene therapy, or oncolytic virus therapy.
- Undergoing other clinical trials.
- A history of anti-tumor vaccines or other immunomodulatory drugs with 4 weeks.
- A history of other type of malignant tumors.
- Unexplained fever.
- A history of autoimmune disease.
- A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- Active hepatitis B, or hepatitis C.
- Severe heart disease (NYHA III or IV), or poorly controlled diabetes.
- Two or more GBM lesions.
- GBM lesion located in the brainstem, cerebellum, posterior fossa, or spinal cord, as well as leptomeningeal diseases.
- A history of diffuse subarachnoid and subarachnoid diseases.
- GBM lesion invades the ventricular wall or tumor cavity communicates with the ventricle after surgery.
- A history of encephalitis, multiple sclerosis, or other central nervous system infections.
- Cerebral herniation syndrome.
- Pregnant and lactating women.
- Other situations that the researcher deems unsuitable for entry into the study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.