Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection

Trial Title: Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection

NCT ID: NCT06018363

Condition: Brain Gliomas

Conditions: Official terms:
Glioma

Conditions: Keywords:
B7H3
CAR-γδT
GBM

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Suspended

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Allogenic B7H3 CAR-γδT cell
Description: Phase 1 dose escalation (3+3) : dose 1 (1 × 10^7 cells) , dose 2 (3 × 10^7 cells), dose 3 (1× 10^8 cells); Phase 2 : dose of RP2D.
Arm group label: ARM

Summary: This is a study on the clinical application of chimeric antigen receptor modified γδ T cells (CAR-γδ T cells) in relapsed and refractory B7H3 Positive malignant brain glioma.The main purpose of this study was to evaluate the safety and feasibility of CAR-γδ T cell infusion in patients with relapsed and refractory B7H3 Positive malignant brain glioma.

Detailed description: γδT cells are known as "a great candidate for car-t cells". Although they only account for 2% - 5% of all T cells in our body, they are a natural killer. Treatment on this study includes six B7H3 CAR-γδ Tcell infusions over an 12 week period. B7H3 CAR-γδ T cells will be locoregionally administered via a CNS reservoir catheter without lymphodepleting chemotherapy. The study will evaluate the safety, feasibility and maximum tolerated dose (MTD) of B7H3 CAR-γδ T cell using a 3+3 study design and an 4 week evaluation period. The total study duration will be 2 years.

Criteria for eligibility:
Criteria:
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 pathohistologic confirmation of high-grade glioma (WHO grade IV), with imaging suggestive of continued progression or recurrence after comprehensive treatment; - 3) Surgically resected pathological tissue capable of being used for immunohistochemical detection of target proteins and positive for B7H3 expression; - 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 109/L;Lymphocyte count (LY) ≥ 0.8 x 109/L;Hemoglobin (Hb) ≥ 90g/L;Platelet (PLT) ≥80×109/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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Dushu Lake Hospital Affiliated to Soochow University

Address:
City: Suzhou
Zip: 215125
Country: China

Start date: June 1, 2023

Completion date: December 31, 2026

Lead sponsor:
Agency: Dushu Lake Hospital Affiliated to Soochow University
Agency class: Other

Source: Dushu Lake Hospital Affiliated to Soochow University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06018363