Clinical Study of Allogeneic Vγ9Vδ2 T Cells in the Treatment of Brain Malignant Glioma

Launched by BEIJING TIANTAN HOSPITAL · May 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment method for aggressive brain tumors, specifically glioblastoma, diffuse intrinsic pontine glioma (DIPG), and medulloblastoma. These types of tumors are known to grow rapidly and can be difficult to treat, often leading to poor outcomes for patients. The study focuses on using a special type of immune cell, called Vγ9Vδ2 T cells, which have shown promise in targeting these tumors due to their ability to recognize specific changes in the cancer cells. The goal is to see if this innovative immunotherapy can improve treatment outcomes for patients who haven’t responded well to standard therapies.

To be eligible for this trial, participants need to be at least 4 years old and have a diagnosed malignant brain tumor that is difficult to treat. They should also have a good level of overall health, as measured by certain tests, and must be able to provide informed consent. Women of childbearing age will need to take a pregnancy test and use contraception during the trial. Participants can expect close monitoring of their health and the effects of the treatment throughout the study. This trial is currently not recruiting participants, but it represents an important step in exploring new options for patients with these challenging brain tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with clinically diagnosed malignant brain glioma in an important structural area (WHO Grade IV);
• • Patients with poor postoperative effect or ineffective guidelines for conventional treatment
• • Age ≥4 years old, male or female;
• • KPS score ≥70;
• * Normal bone marrow reserve function and normal liver and kidney function (as evidenced by the following laboratory tests prior to initial Vγ9Vδ2 T cell therapy) :
• • Neutrophil absolute value ≥ 1,500/mm3;
• • hemoglobin 10g/dL;
• • Platelet count \> 100,000/mm3;
• • Glutamic pyruvic transaminase/Glutamic oxalacetic transaminase \< 2.5 x ULN;
• • Serum creatinine 1.5×ULN;
• • Total bilirubin levels \< 1.5 x ULN.
• • No obvious genetic diseases;
• • Normal cardiac function, cardiac ejection index \> 55%;
• • Suitable for implantation of Ommaya capsule in ventricle or cavity;
• • No bleeding and coagulation disorders;
• • Women of reproductive age (15-49 years) must undergo a negative pregnancy test within 7 days before starting treatment and use contraception during the clinical trial period and within 3 months after the last cell transfusion;
• • Sign the informed consent form.
• Exclusion Criteria:
• • Pregnant and lactating women;
• • Organ failure;
• • Heart: Grade III and grade IV;
• • Liver: Level C of the Child-Turcotte liver function scale;
• • Kidney: renal failure and uremia stage;
• • Lungs: Symptoms of severe respiratory failure;
• • Brain: A person with a disorder of consciousness.
• • Patients with a history of organ transplantation;
• • Uncontrollable infectious disease or other serious illness, including but not limited to infection (such as HIV positive), congestive heart failure, unstable angina pectoris, arrhythmia, psychosis, or restrictive social environment or what the attending physician considers to be an unpredictable risk;
• • Patients with systemic autoimmune disease or immunodeficiency;
• • Patients with allergic constitution;
• • Use of systemic steroid drugs;
• • Have a chronic disease that requires the use of immune agents or hormone therapy;
• • Prior treatment with any other immune cell;
• • Have participated in other clinical trials within the past 30 days;
• • The researchers believe that other reasons are not suitable for clinical trials