EUCTR2015-005594-21-GB进行中（未招募）1 期
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1c259T in HLA-A2+ Patients with Synovial Sarcoma - A Pilot Study of NY-ESO-1c259T in Synovial Sarcoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Pathologically or histologically confirmed synovial sarcoma that has been treated with a standard chemotherapy regimen containing ifosfamide and/or doxorubicin, is intolerant of or not actively responding to this regimen and remains:
- •unresectable or (intent is not to enrol patients with resectable tumors)
- •metastatic or progressive/persistent or recurrent
- •2.Patients must have measurable disease in order to allow assessment of an anti-tumor response
- •3.Pathologic review by a central laboratory designated by the Sponsor and confirming NY-ESO-1 expression by immunohistochemistry (IHC). Patients must have proven positive tumor sample for NY-ESO-1 as follows:
- •Cohort 1: Positive expression is defined as 2+ or 3+ by IHC in = 50% cells
- •Cohort 2: Positive expression is defined as = 1+ by IHC in = 1% cells but not to exceed 2+ or 3+ in = 50% cells
- •Cohort 3: Positive expression is defined as 2+ or 3+ by IHC in = 50% cells
- •Cohort 4: Positive expression is defined as 2+ or 3+ by IHC in = 50% cells
- •4.HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 by high resolution testing
- •5.Patient is =4 years of age on the day the Informed Consent is signed
- •6.Patients must be >18 kg, for apheresis safety purposes
- •7.Patients may have received salvage chemotherapy or other therapies. Prior Therapies
- •All previous cytotoxic chemotherapy, monoclonal antibody therapy, or immune therapy should be washed out 3 weeks before apheresis and must be completed at least 3 weeks prior to pre-infusion lymphodepleting chemotherapy
- •Systemic corticosteroid or other immunosuppressive therapy should be washed out 2 weeks before apheresis and must be completed at least 2 weeks prior to pre-infusion lymphodepleting chemotherapy
- •Biologic or other approved molecular targeted small molecule inhibitors should be washed out 1 week or 5 half-lives (whichever is longer) before apheresis and must be completed at least 1 week or 5 half-lives (whichever is longer) prior to pre-infusion lymphodepleting chemotherapy
- •Any grade 3 or 4 hematologic toxicity of previous therapy must have resolved to grade 2 or less (or to values specified below) prior to apheresis and any grade 3 or 4 toxicity must have resolved to grade 2 or less (or to values specified below) prior to pre-infusion lymphodepleting chemotherapy
- •8.Performance status: ECOG 0-1, or for children =10 years of age, Lansky >60
- •9.Life expectancy >3 months
- •10.Patient must have adequate organ function as indicated by the following laboratory values below
- •Absolute Neutrophil count (ANC) = 1.0 x10^9/L
- •Platelets = 75 x10^9/L (not achieved by transfusion)
- •Creatinine clearance = 40 ml/min
- •Patients <65 yrs of age can be assessed using estimated creatinine clearance calculated using the Cockcroft and Gault formula
- •Patients =65 yrs of age must have renal function measured either by 24-hour urine creatinine collection or by nuclear medicine GFR measurement, according to standard practice at the treating institution
- •Serum total bilirubin< 2 mg/dl
- •(If patient has Gilberts syndrome: total bilirubin <3xULN and direct bilirubin <35%)
- •Serum AST and ALT = 2.5 x Upper Limit of Normal
- •Left ventricular ejection fraction =40%, or Fractional Shortening =28%
- •11.Ability to give informed consent prior to any study-specific procedures. Any standard of care procedures (e.g., lab tests, scans) can be used for purposes of assessing study eligibility as long as all other requirements as stated in the protocol are met. For patients <18 years of age (or the lega
排除标准
- •1.Clinically significant systemic illness (e.g. serious active infections or significant cardiac,
- •pulmonary, hepatic or other organ dysfunction), that in the judgment of the PI would compromise the patient’s ability to tolerate protocol therapy or significantly increase the risk of complications
- •2.Untreated CNS metastasis. Extradural masses that have not invaded the brain parenchyma or parameningeal tumors without evidence for leptomeningeal spread will not render the patient ineligible. Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks are eligible.
- •3.Previous treatment with genetically engineered NY-ESO-1 specific T cells.
- •4.Pregnant or breastfeeding females (due to risk to fetus or newborn).
- •5.Active HIV, HBV, HCV or HTLV 1 or 2 infection as defined below (due to increased risk of complications during the lymphodepleting regimen and confounding effects on the immune system):
- •Positive serology for HIV.
- •Active hepatitis B infection as demonstrated by test for hepatitis B surface antigen. Subjects who are hepatitis B surface antigen negative but are hepatitis B core antibody positive must have undetectable hepatitis B DNA and receive prophylaxis against viral reactivation. Prophylaxis should be initiated prior to lymphodepleting therapy and continued for 6 months.
- •Active hepatitis C subjects as demonstrated by test for hepatitis C RNA. Subjects who are HCV antibody positive will be screened for HCV RNA by any RT PCR or bDNA assay. Eligibility will be determined based on a negative screening value.
- •Positive serology for HTLV 1 or 2.
- •6.Subject has history of active, chronic or recurrent (within the last year prior to enrolment) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments.
研究者
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