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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06018363
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dushu Lake Hospital Affiliated to Soochow University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Gliomas
Additional Details

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.

Arms & Interventions

Arms

Experimental: ARM

Patients with refractory or relapsed B7H3 positive GBM

Interventions

Biological: - Allogenic B7H3 CAR-γδT cell

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Suzhou, Jiangsu, China

Status

Recruiting

Address

Dushu Lake Hospital Affiliated to Soochow University

Suzhou, Jiangsu, 215125

Site Contact

Yulun Huang

[email protected]

+86 130 1388 9432

Stay Informed & Connected