EUCTR2019-000589-39-GB进行中（未招募）1 期
A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma - A phase 2 single arm, open phase study of ADP-A2M4 SPEAR T cells
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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. Subject (or legally authorized representative) voluntarily agrees to participate by giving written Informed Consent
- •(and Assent as applicable)in accordance with ICH GCP guidelines and applicable local regulations.
- •2. Subject (or legally authorized representative) agrees to abide by all protocol required procedures including study
- •related assessments and management by the treating institution for the duration of the study, including long term
- •follow-up.
- •3. Age =16 and <75 years at the time the Pre-screening informed consent/assent is signed.
- •4. Diagnosis of advanced (metastatic or inoperable) synovial sarcoma or myxoid liposarcoma / myxoid round cell
- •liposarcoma confirmed by cytogenetics. Inoperable refers to a tumor lesion in which clear surgical excision margins
- •cannot be obtained without leading to significant functional compromise.
- •a. For Synovial Sarcoma: confirmation by the presence of a translocation between SYT on the X chromosome and
- •SSX1, SSX2 or, SSX4 on chromosome 18 (may be presented in the pathology report as t (X; 18)).
- •b. For MRCLS: confirmation by the presence of the reciprocal chromosomal translocation t(12;16)(q13;p11) or t(12; 22)
- •5. Must have previously received either an anthracycline or ifosfamide containing regimen. Subjects who are intolerant
- •to both anthracycline and ifosfamide must have previously received at least one systemic therapy.
- •6. Measurable disease according to RECIST v1.1.
- •7. Positive for HLA-A*02:01, HLA-A*02:03, HLA-A*02:06 allele via Adaptimmune designated central laboratory testing. HLA-A*02 alleles having the same protein sequence as these alleles in the peptide binding domains (P group) will also be included. Other HLA-A*02 alleles may be eligible after adjudication with the sponsor.
- •8. Tumor (either an archival specimen or a fresh biopsy) shows MAGE-A4 expression of =2+ staining in =30% of the
- •cells by immunohistochemistry. All samples must have been pathologically reviewed by an Adaptimmune designated
- •central laboratory confirming expression.
- •9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- •10. Left ventricular ejection fraction (LVEF) =50%.
- •11. Fit for leukapheresis and adequate venous access can be established for the
- •cell collection.
- •12. Female subjects of childbearing potential (FCBP) must have a negative urine or serum pregnancy test AND mustagree to use an effective method of contraception starting at the first dose of chemotherapy and continuing for at least
- •12 months, or 4 months after the gene modified cells are no longer detected in the blood, whichever is longer.
- •Male subjects must be surgically sterile or agree to use a double barrier contraception method or abstain from
- •heterosexual activity with a FCBP starting at the first dose of chemotherapy and continuing for 4 months thereafter (or
- •longer if indicated in the country specific monograph/label for cyclophosphamide).
- •13. Must have adequate organ function as indicated by the laboratory values in
- •a table from the protocol. Please see protocol page 20
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Positive for HLA-A*02:05 in either allele via Adaptimmune designated central laboratory testing. HLA-A*02 alleles having the same protein sequence as HLA-A*02:05 in the peptide binding domain (P groups) will also be excluded. Other alleles may be exclusionary after adjudication with the sponsor.
- •2. Received or plans to receive therapy/treatment prior to leukaphereseisis or lymphodepleting chemotherapy
- •3. Toxicity from previous anti-cancer therapy must have recovered to = Grade 1 prior to enrollment (except for nonclinically
- •significant toxicities, e.g., alopecia, vitiligo). Subjects with Grade 2 toxicities that are deemed stable or
- •irreversible (e.g. peripheral neuropathy) can be enrolled.
- •4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine,
- •cyclophosphamide or other agents used in the study.
- •5. History of autoimmune or immune mediated disease. Subjects with hypothyroidism, diabetes, adrenal insufficiency
- •or pituitary insufficiency that are stable on replacement therapy are eligible. Subjects with disorders such as asthma,
- •psoriasis or atopic dermatitis that are well controlled without requiring systemic immunosuppression are also
- •6. Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases. Subjects with a prior
- •history of symptomatic CNS metastases must have received treatment (i.e., stereotactic radiosurgery (SRS), whole
- •brain radiation (WBRT) or surgery) and be neurologically stable for at least 1 month, not requiring anti-seizure
- •medications and off of steroids for at least 14 days prior to leukapheresis and lymphodepletion. Antiseizure
- •prophylaxis is permitted. Subjects who have
- •asymptomatic CNS metastases without associated edema, shift, requirement for steroids
- •or anti-seizure medications for the treatment of seizures are eligible.
- •7. Any other prior malignancy that is not in complete remission. Resectable
- •squamous or basal cell carcinoma of the skin is acceptable. Prior malignancies that have been surgically resected
- •and show no evidence of disease are acceptable.
- •8. Uncontrolled intercurrent illness including, but not limited to:
- •Ongoing or active infection;
- •Clinically significant cardiac disease defined by congestive heart failure New York Heart Association (NYHA) Class 3
- •or Class 4;
- •Uncontrolled clinically significant arrhythmia;
- •Acute Coronary Syndrome (ACS) (angina or MI) in last 6 months;
- •Interstitial lung disease (subjects with existing pneumonitis as a result of radiation are not excluded, however,
- •subjects must not be oxygen dependent);
- •Congenital or family history of long QT syndrome;
- •Current uncontrolled hypertension despite optimal medical therapy;
- •History of stroke or central nervous system bleeding; transient ischemic attack (TIA) or reversible ischemic
- •neurologic deficit (RIND) in last 6 months;
- •9. Active infection with HIV, HBV, HCV or HTLV as defined below:
- •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 infection as demonstrated by hepatitis C RNA test. Subjects who are HCV antibody positive will be
- •screened for HCV RNA by any RT PCR or
研究者
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