NCT06396481Not yet recruitingEarly phase 1
Clinical Study of Allogeneic Vγ9Vδ2 T Cells in the Treatment of Brain Malignant Glioma
Source: ClinicalTrials.gov · Last updated 2 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Primary brain malignant tumor has become the first lethal tumor in children and young adults, and the treatment is limited, and the prognosis of patients is poor. According to the classification of the World Health Organization, glioblastoma is divided into grade II, III and IV gliomas; The higher the degree of malignancy, the worse the clinical outcome. Among them, the most malignant, most lethal, and most common types of tumors include supratentorial glioblastoma, diffuse endopontine glioma (DIPG), medulloblastoma, and ependymoma. Its high malignancy is mainly manifested in three aspects: extremely rapid growth and obvious invasion; The operation is not easy to remove all; The tumor has a tendency of recurrence and disseminated implantation. It can occur with children and adults of all ages. At present, surgery combined with chemoradiotherapy is the main treatment, but the therapeutic effect is not good. Studies have shown that glioblastoma, as the most common primary brain malignant tumor in adults, after standard surgery, radiotherapy and chemotherapy, the median survival time is less than 15 months, and the overall five-year survival rate is only 5.4%. Even after receiving new and expensive Tumor-treating fields, the median survival time is less than 21 months. The median survival time of DIPG patients is generally less than 1 year, and the 5-year survival rate is less than 5%. The average 5-year survival rate of medulloblastoma and anaplastic ependymoma is 40%\~60%. Innovative treatments are urgently needed. Immunotherapy based on Vγ9Vδ2 T cells has become a promising research direction in recent years. Its unique phosphine antigen recognition does not depend on major histocompatibility complex (MHC), easy to allograft and other advantages. Making it one of the most promising cell therapies. Brain glioma has abnormal cholesterol metabolism and phosphine antigen accumulation, which is easily sensed by Vγ9Vδ2 T cells. Therefore, the clinical exploration of Vγ9Vδ2 T cells for glioma is of great significance to both the scientific and clinical communities.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 29 Mar 2024
- Start date
- 30 Apr 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT06396481
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 25
- From 30 Apr 2024 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of systemic steroid drugs;
- Prior treatment with any other immune cell;
Other illness
- Organ failure;
- Heart: Grade III and grade IV;
- 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;
- Have a chronic disease that requires the use of immune agents or hormone therapy;
Other
- Pregnant and lactating women;
- Liver: Level C of the Child-Turcotte liver function scale;
- Have participated in other clinical trials within the past 30 days;
- The researchers believe that other reasons are not suitable for clinical trials
Who the study is looking for
- 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.
Age in the registry: 4 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.