ACTRN12622001514796招募中未知
KARPOS - A Phase 1, Single-Centre, Non-randomised, Open-labelled, Escalating Dose Study of Autologous GD2-Specific Chimeric Antigen Receptor-expressing Peripheral Blood T cells in Patients with Recurrent GD2-positive Glioblastoma Multiforme
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Procurement Inclusion Criteria
- •1. 18 years of age or above
- •2. Must be able and willing to provide written informed consent
- •3. Must be able and willing to reside within 100km of site where GD2-iCAR-PBT infusion is administered for entire duration of safety follow-up period (up to 30 days post GD2-iCAR-PBT infusion)
- •4. Patient must be able to nominate an in-residence carer for at least 7 days post GD2-iCAR-PBT infusion
- •5. Adult-type diffuse glioma in a supratentorial tumour location, histologically confirmed as WHO grade 4 IDH-wildtype glioblastoma with lack of MGMT promoter methylation, and which has been treated with maximally safe debulking and has been or is proposed to be treated with standard post-operative radiotherapy without either concurrent or consolidation temozolomide chemotherapy
- •6. Adult-type diffuse glioma, which is histologically confirmed as WHO grade 4 IDH-wildtype glioblastoma or IDH-mutant astrocytoma (2021 WHO Classification of Tumours of the CNS), or previously histologically confirmed WHO grade 2 or grade 3 glioma (i.e., astrocytoma or oligodendroglioma) clinically and/or radiologically behaving as recurrent grade 4 glioma, together with greater than or equal to 10% GD2-positive tumour cells by 14g2a immunohistochemistry (IHC), and a supratentorial tumour location.
- •7. Evidence of first or subsequent recurrence of GBM (rGBM) radiologically by brain perfusion MRI after completion of the standard Stupp regimen, which includes maximal or subtotal resection as defined by the surgeon and completion of 6 cycles of consolidation temozolomide chemotherapy, or other standard treatment that includes surgery, radiotherapy, and chemotherapy e.g., for WHO grade 2 or grade 3 glioma (i.e., astrocytoma or oligodendroglioma). Clinically indicated neurosurgical intervention including biopsy and tumour re-resection will be considered for rGBM patients after discussion in a neuro-oncology multidisciplinary meeting.
- •8. ECOG performance status of at least 2 expected at infusion.
- •9. Stable dose of steroids for 5 days, no more than 2 mg dexamethasone (or equivalent) total per day
- •Treatment Inclusion criteria
- •1. Must be able and willing to reside within 100km of site where GD2-iCAR-PBT infusion is administered for entire duration of safety follow-up period (up to 30 days post GD2-iCAR-PBT infusion)
- •2. Patient must be able to nominate an in-residence carer for at least 7 days post GD2-iCAR-PBT infusion
- •3. Availability of CAR-T-cell product that has met batch release criteria including greater than or equal to 10% expression of GD2-iCAR (by flow cytometry) on autologous peripheral blood T cells
- •4. Evidence of first or subsequent recurrence of GBM (rGBM) radiologically by brain perfusion MRI after completion of the standard Stupp regimen, which includes maximal or subtotal resection as defined by the surgeon and completion of 6 cycles of consolidation temozolomide chemotherapy, or other standard treatment that includes surgery, radiotherapy, and chemotherapy e.g., for WHO grade 2 or grade 3 glioma (i.e., astrocytoma or oligodendroglioma). Clinically indicated neurosurgical intervention including biopsy and tumour re-resection will be considered for rGBM patients after discussion in a neuro-oncology multidisciplinary meeting
- •5. Measurable disease on at least 2 dimensions on MRI brain scan
- •6. ECOG performance status of at least 2
- •7. Pulse oximetry greater than or equal to 90% in room air
- •8. Stable dose of steroids for 5 days,
排除标准
- •Procurement Exclusion Criteria
- •1. Inability to comply with study and follow-up procedures (including, but not limited to geographical or administrative reasons such as lack of ambulance insurance or residence more than 100km away from trial site for up to 30 days post GD2-iCAR-PBT infusion)
- •2. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count less than or equal to 1.0 x 109/L or platelet count less than or equal to 100 x 109/L (cannot be post-transfusion) or haemoglobin less than 100 g/L (can be post-transfusion)
- •3. Participation in a trial of an investigational agent within the 7 days before enrolment
- •4. Pregnant or breast-feeding females
- •5. Evidence of active infection with HIV, hepatitis B, or hepatitis C
- •6. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
- •7. Evidence of severe or uncontrolled systemic diseases (e.g., infection requiring treatment with intravenous (IV) antibiotics, unstable or uncompensated respiratory, cardiac [including life-threatening arrhythmias], hepatic, or renal disease
- •8. Any concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in this
- •Treatment Exclusion Criteria
- •1. Inability to comply with study and follow-up procedures (including, but not limited to geographical or administrative reasons such as lack of ambulance insurance or residence more than 100km away from trial site for up to 30 days post GD2-iCAR-PBT infusion)
- •2. Has evidence clinically or radiologically by brain perfusion MRI or MR spectroscopy of pseudo-progression or radiation necrosis during or after treatment, not considered to be true progression after discussion in neuro-oncology multi-disciplinary meeting
- •3. Has tumour localised below the tentorium
- •4. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count less than or equal to 1.5 x 109/L or platelet count less than or equal to 100 x 109/L (cannot be post-transfusion) or haemoglobin less than 100 g/L (can be post-transfusion) unless lymphodepletion chemotherapy has been administered
- •5. International Normalised Ratio (INR) or Prothrombin Time (PT) or Activated Partial Thromboplastic Time (aPTT) greater than 1.5 times the upper limit of normal (x ULN) unless the subject is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants
- •6. Serum bilirubin greater than 1.5 x ULN
- •7. Liver transaminase levels greater than 5 x ULN
- •8. Creatinine clearance of lesser than or equal to 50mL/min calculated by Cockcroft-Gault
- •9. Pregnant or breast-feeding females
- •10. History of hypersensitivity to reactions to murine protein-containing products
- •11. Evidence of active infection with HIV, hepatitis B, or hepatitis C
- •12. Has a documented history of a clinically severe autoimmune disease or syndrome that required systemic steroids or immunosuppressive agents within the past month. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
- •13. Refractory
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