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New treatment option for Brain Gliomas
Official title Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection
ClinicalTrials.gov ID: NCT06018363
What this study is testing
What is Allogenic B7-H3 CAR-γδT cell(QH104)?
Allogenic B7-H3 CAR-γδT cell(QH104) is an investigational medicine, being studied as a potential treatment for brain gliomas.
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
- B7-H3 is expressed at low levels in normal tissues but overexpressed in various tumor tissues. The ubiquitous expression of B7-H3 in tumors of different grades is a key feature for brain gliomas.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 1)Age 18-70 years old (both ends included), both male and female;
- 2)At least one evaluable lesion, with previous biopsy or histopathological confirmation of high-grade glioma (WHO grade 3-4), and after comprehensive...
- 3) The pathological tissues removed by surgery can be used for immunohistochemical detection of target proteins (paraffin sections should be within...
- 4) KPS ≥ 60 points;
- 5)Expected survival \> 3 months;
You likely can't join if
- 1)Pregnant and lactating women;
- 2)Those with organ failure:Heart: Class III and IV;Liver: up to grade C of the Child-Turcotte Liver -Function Classification;Kidney: chronic kidney...
- 3)patients with combined second tumors;
- 4)patients with active hepatitis B or C virus, HIV infection, or other untreated active infection;
- 5)any severe, uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus...
- 6)Current systemic use of steroid cell (except for recent or current use of inhaled steroids) substances;
See the full eligibility criteria
- 1)Age 18-70 years old (both ends included), both male and female;
- 2)At least one evaluable lesion, with previous biopsy or histopathological confirmation of high-grade glioma (WHO grade 3-4), and after comprehensive treatment, imaging examination indicates continued progression or...
- 3) The pathological tissues removed by surgery can be used for immunohistochemical detection of target proteins (paraffin sections should be within half a year), and the expression of B7-H3 is positive;
- 4) KPS ≥ 60 points;
- 5)Expected survival \> 3 months;
- 6)Substantially normal bone marrow reserve function and normal liver and renal function (laboratory tests need to be fulfilled before receiving QH104 Cell Injection for the first time):White blood cell count (WBC) ≥ 3 x...
- 7)No obvious hereditary diseases;
- 8)Normal cardiac function with cardiac ejection index \>55%;
- 9)No bleeding and coagulation disorders;
- 10)Women of childbearing age (15-49 years old) must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and people are willing to use contraception during the clinical trial...
- 11) Sign the informed consent form.
- 1)Pregnant and lactating women;
- 2)Those with organ failure:Heart: Class III and IV;Liver: up to grade C of the Child-Turcotte Liver -Function Classification;Kidney: chronic kidney disease stage 4 or above; renal insufficiency stage III or above;Lungs...
- 3)patients with combined second tumors;
- 4)patients with active hepatitis B or C virus, HIV infection, or other untreated active infection;
- 5)any severe, uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal...
- 6)Current systemic use of steroid cell (except for recent or current use of inhaled steroids) substances;
- 7) have a chronic disease requiring immunologic or hormonal therapy;
- 8) have an allergy to immunotherapy and related cells;
- 9) 10)Patients with a history of organ transplantation or who are awaiting organ transplantation;
- 10)Participation in other clinical trials within the previous 30 days;
- 11)Those who are not suitable for clinical trials for other reasons in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, 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.