ACTRN12622001542785终止1 期
A Pilot Study Assessing Safety and Tolerability of Lewis Y (LeY) targeting Chimeric Antigen Receptor (CAR) T cells in combination with Nivolumab in Patients With LeY Expressing Solid Tumours
Peter MacCallum Cancer Centre0 个研究点目标入组 4 人开始时间: 2022年12月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
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
- •1. Patient has provided written confirmation of informed consent on participant information and consent form (PICF)
- •2. Patients with an advanced solid tumour (defined as incurable locally advanced or metastatic disease and excluding any haematologic malignancy) Patients who are eligible for PBS-reimbursed PD1 or PD-L1 inhibitors must have received this prior to study enrolment
- •3. Tumour is positive for LeY expression by immunohistochemistry (IHC) defined as a staining of greater than or equal to 10 % of tumour cells positive for LeY expression
- •4. Patient is at least 18 years of age at the time of consent
- •5. Patient has an ECOG performance status of 0-1
- •6. Life expectancy of greater or equal to 12 weeks
- •7. Patient has adequate organ function satisfying all of the following:
- •-Bilirubin less than or equal to 1.5x upper limit of normal (ULN) unless patient has known Gilbert’s syndrome, then less than or equal to 3x ULN
- •-AST/ALT less than or equal to2.5 x ULN except in patients with known liver metastases where AST/ALT less than or equal to 5.0 x ULN
- •-Serum creatinine less than 1.5x ULN or creatinine clearance greater than 50ml/min. Creatinine clearance is either derived using the Cockcroft-Gault formula or may be measured by 24 hour urine collection or nuclear medicine assessment
- •-Adequate pulmonary function defined by SaO2 greater than 91% on room air and less than or equal to grade I dyspnoea
- •-Left ventricular ejection fraction (LVEF) greater than or equal to 40% as confirmed by echocardiogram (ECHO) or multiple uptake gated acquisition (MUGA)
- •-Absolute neutrophil count (ANC) greater than or equal to 1.0 x 10^(9)/L
- •-Absolute lymphocyte count greater than or equal to 0.5 x 10^(9)/L
- •-Platelets greater than or equal to 100 x 10^(9)/L
- •-Haemoglobin greater than or equal to 80g/L
- •-White cell count (WCC) less than 30 x 10^(9)/L
- •8. Patient is deemed capable and willing to undergo the planned study procedures in the view of the Investigator
- •9. Patient has measurable disease as per RECIST 1.1
- •10. For patients undergoing the (64)^Cu SPION imaging:
- •a. Patient must pass institutional MRI safety questionnaire
- •b. Patient must not exceed physical limitations of scanner (weight greater than 105kg and/or height greater than 185cm)
- •c. Patient must feel they are able to tolerate proposed imaging sequences (e.g. Patient must not suffer from severe claustrophobia or other condition that would prevent them from undergoing MRI)
- •d. Patients must not have a known allergy to nickel or palladium
- •11. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •12. Female patients of childbearing potential must be willing to commit to either abstaining continuously from heterosexual intercourse or agree to practice 2 methods of reliable birth control simultaneously. Where one of the methods is a highly effective method of contraception (failure rate of less than 1% per year when used consistently and correctly; see examples below) and one other effective method (i.e., male latex or synthetic condom, diaphragm, or cervical cap) and patient must agree to remain on both methods from the time of signing the patient information and consent form (PICF) until at least 1 year after receiving LeY CAR T cell therapy. Reliable contraception is indicated even where there has been
排除标准
- •1. Patients with known active central nervous system (CNS), involvement by malignancy. [N.B. Patients with previously treated and/or neurologically stable disease (asymptomatic brain metastases not requiring steroid treatment) will be eligible]
- •2. Prior CAR T cell therapy
- •3. Patient has been given chemotherapy and/or granulocyte-colony stimulating factor (G-CSF) within 4 weeks of study registration or is planned to receive such therapy prior to apheresis of PBMC. Patients can only receive cytotoxic drugs as per the schedule of treatment for this protocol
- •4. Patient has had immunosuppressive therapy within 4 weeks of apheresis. Therapeutic doses of steroids (defined as greater than 10 mg/day of Prednisolone (or equivalent)) must be able to be stopped within 7 days prior to leukapheresis and 72 hours prior to LeY CAR T cell infusion. Physiologic doses of steroid (e.g. Prednisolone less than 10mg or equivalent), topical and inhaled steroids are permitted
- •5. Patients who are eligible for potentially curative therapy
- •6. Uncontrolled active or latent Hepatitis B (HBV) or active Hepatitis C (HCV) or HIV
- •7. Patients with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate treatment
- •8. A presence of active clinically relevant CNS pathology such as epilepsy, aphasia, severe brain injury, dementia, Parkinson’s disease, cerebellar disease or psychosis
- •9. Radiation therapy within 2 weeks prior to registration
- •10. Patient has an active other haematologic or solid malignancy with the exception of superficial BCC or SCC
- •11. Patient has a history of significant pulmonary disease (including radiation pneumonitis) or known, biopsy proven autoimmune inflammatory disease of the gastrointestinal tract
- •12. Unstable angina or myocardial infarct within 6 months prior to screening
- •13. Patient has known clinically significant autoimmune disease
- •14. Women who are pregnant or breastfeeding
- •15. Patient has a serious uncontrolled medical disorder, psychological or social factors that which would impair their ability to receive protocol therapy and follow up in the opinion of the investigator
- •16. Receipt of live attenuated vaccination within 30 days of registration
- •17. Prior allogeneic organ transplant, inflammatory bowel disease, pneumonitis, tuberculosis, or primary immunodeficiency
- •18. Have a history of allergy to study drug components, or a history of severe hypersensitivity reaction to any mAb
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