💬In plain words
What the trial is, and whether it could suit you
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. The immunohistochemistry study showed that B7-H3 is abundantly expressed on both glioma (especially high-grade glioma) cells and tumor-associated endothelial cells. For GBM, the expression of B7-H3 is intensely positive, especially on tumor cells and vascular endothelial cells, which makes B7-H3 a potential immunotherapeutic target.
γδ T cells recognize tumor cells without being restricted by MHC molecules, and thus can be used in allogeneic therapy without the risk of causing graft-versus-host disease.
This study is an open-label, single-arm, dose-escalation and dose-expansion clinical study aimed at evaluating the safety and efficacy of allogeneic B7-H3 CAR γδT in patients with malignant gli
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion 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 recurrence;
* 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 10\^9/L;Lymphocyte count (LY) ≥ 0.8 x 10\^9/L;Hemoglobin (Hb) ≥ 90g/L;Platelet (PLT) ≥80×10\^9/L;Albumin transaminase (ALT) \& albumin transaminase (AST) \<1.5×ULN;Serum creatinine (Cr) \<1.5 x ULN;Total bilirubin \< 1.5 x ULN;PT \& PTT ≤ 1.25 x ULN.
* 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 subjects are willing to use contraception during the clinical trial and for 3 months after the last cell infusion;
* 11\) Sign the informed consent form.
Exclusion Criteria:
* 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: symptoms of severe respiratory failure with involvement of other organs;Brain: central nervous system abnormalities or impaired consciousness;
* 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 arteritis;
* 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.
💊
What it tests
- Allogenic B7-H3 CAR-γδT cell(QH104)
Dushu Lake Hospital Affiliated to Soochow University
Suzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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