ISRCTN22366199进行中（未招募）1 期
Immunotherapy using CAR T-cells to target EGFRvIII for relapsed/refractory adult Glioblastoma
niversity College London0 个研究点目标入组 12 人开始时间: 2024年8月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age =16 years
- •2. Disease status:
- •2.1. Relapsed or recurrent IDH-wildtype GBM confirmed by pathology review of surgically resected tissue, and
- •2.2. Tumour tissue is positive for EGFRvIII expression as performed by immunohistochemistry (IHC)
- •3. Written informed consent (or where applicable, consent by a legal representative)
- •4. Agree to undergo a pregnancy test and use adequate contraception (where applicable)
- •Trial inclusion criteria: for radiotherapy:
- •5. =6 months since completion of primary radiotherapy.
- •6. Prior history of standard dose, conventionally fractionated brain radiotherapy (i.e. 54 - 60Gy in 28 - 33 fractions).
- •7. Up to and including three enhancing lesions.
- •8. Predicted re-irradiation Gross Tumour Volume <50cm³
- •9. Maximum diameter of enhancing disease must be =6cm
排除标准
- •1. ECOG 3 - 4
- •2. Metastatic or primary spinal GBM
- •3. Organ function:
- •3.1. Cardiac: Serious and uncontrolled cardiac arrythmias despite medical management, history of ischemic heart disease within the last 6 months before eligibility confirmation and left ventricular ejection fraction (LVEF) <40%
- •3.2. Pulmonary: Requirement for supplemental oxygen and/or oxygen saturation =90% on air
- •3.3. Renal: Creatinine clearance <50ml/min
- •3.4. Hepatology: Bilirubin >2x upper limit of normal
- •3.5. Neurologic: Pre-existing significant neurological disorders unrelated to the CNS malignancy investigated in this study
- •4. Active hepatitis B, C or HIV
- •5. Active severe infection
- •6. History of or active medical or psychiatric condition that is uncontrolled with current treatment or deemed by the investigators to be severe enough to preclude participation in this study
- •7. Unable to undergo leukapheresis due to contraindications, inability to tolerate procedure and/or issues with adequate venous access for the procedure
- •8. Known allergy to study product excipients (albumin, DMSO, dextran)
- •9. Cohort 3 only: Any contraindications to receiving ipilimumab including history of clinically significant pneumonitis or lung fibrosis <24 weeks before registration
- •10. History of auto-immune disease or connective tissue disease requiring systemic immunosuppression/disease-modifying agents within 24 months before registration or resulting in end-organ damage
- •11. Steroid therapy requiring >2mg dexamethasone (or equivalent) daily
- •12. Women who are pregnant or breast feeding
研究者
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