Clinical trial NCT05459441: Efficacy and Safety Evaluation of Percutaneous Ommaya Capsule Injection of Autologous Bi-dimensional Specific T Cells in the Treatment of Glioma and in Combination With Pemetrexed in the Treatment of Brain/Meningeal Metastases
Official title: Efficacy and Safety Evaluation of Percutaneous Ommaya Capsule Injection of Autologous Bi-dimensional Specific T Cells in the Treatment of Glioma and in Combination With Pemetrexed in the Treatment of Brain/Meningeal Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Glioma
Brain Metastases
Lead sponsor: Shanghai Pudong Hospital
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single center prospective clinical study
Primary purpose: TREATMENT

Brief summary: Cerebral metastases are common intracranial tumor, its incidence increased year by year, in recent years, although the whole brain radiation therapy, surgical resection, stereotactic radiosurgery treatment, targeted drugs, and other comprehensive treatment in patients with symptoms of mitigation and the extension of survival has played a positive role, but due to individual differences, treatment in patients with poor compliance were a lot of factors, Further treatment of brain metastases after conventional treatment requires the assistance and cooperation of clinical multi-disciplines. To evaluate the efficacy and safety of percutaneous Ommaya capsule injection of autologous bi-dimensional specific T cells in the treatment of glioma and combined with pemetrexed in the treatment of brain/meningeal metastasis. Using translational research techniques and means, to find molecular indicators related to clinical prognosis and outcome, establish the clinical use standard of this holistic treatment technology, and popularize it in multi-centers.


Eligibility criteria: Inclusion Criteria:

1. Clear diagnosis of glioma; The pathological diagnosis of the primary lesion is clear, and the intracranial lesion can be diagnosed as intracranial metastasis by clinical, cerebrospinal fluid and imaging diagnosis according to the standards of the European Society of Neuro-Oncology - European Society of Medical Oncology (EANo-ESMO).
2. Patients with glioma and solid tumor with brain metastasis who have relapsed after surgery, whole brain radiotherapy or chemotherapy, or who are intolerant and not suitable for surgery or radiotherapy, and who are determined by clinicians to no longer benefit from systemic chemotherapy;
3. Surgical indications for Ommaya capsule implantation;
4. Age ≥18 years old and ≤80 years old, regardless of gender;
5. ECOG score for general physical condition is 0 \~ 2;
6. The expected survival time is at least 1 month;
7. WBC≥3.0×109/L, Hb≥90g/L, PLT≥75×109/L at baseline upon enrollment;
8. Liver and kidney function are basically normal A) Liver: total bilirubin ≤2.0 mg/dL (34.2umol/L), AST and ALT≤ 2.5 times the upper limit of normal value, AST and ALT≤ 5 times the upper limit of normal value in patients with liver metastasis.

   B) Kidney: creatinine ≤2.5 mg/dL (221umol/L), creatinine clearance ≥60 mL/min;
9. Understand and sign informed consent to participate in clinical study voluntarily.

Exclusion Criteria:

1. Patients with primary brain tumors other than glioma;
2. Patients with systemic metastasis, poor general condition, and expected survival time less than 1 month;
3. People allergic to pemetrexed;
4. Severe coagulation disorder;
5. Severe active infection and other serious complications;
6. Patients with active viral hepatitis;
7. There are urgent intracranial symptoms (cerebral hernia, etc.), systemic diseases affecting treatment, and basic diseases affecting patients' cognitive function (such as cerebrovascular diseases, Alzheimer's disease, etc.);
8. Pregnant or lactating women;
9. Within 4 weeks prior to enrollment, translumbar administration was performed;
10. Other factors considered by researchers are not suitable candidates.

Primary outcomes:
measure: Clinical response rate
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 24 months
measure: Safty(adverse events)
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Pudong Medical Center
state: Shanghai
Study officials:
affiliation: Fudan University Pudong Medical Center
name: Jun Ren, MD,PhD
role: STUDY_CHAIR
References: