CTIS2024-512847-21-00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(SPEARHEAD 1 STUDY) - ADP-0044-002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 162
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
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •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, Left ventricular ejection fraction (LVEF) =50%, Fit for leukapheresis and adequate venous access can be established for the cell collection, Female subjects of childbearing potential (FCBP) must have a negative urine or serum pregnancy test AND must agree 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. - OR 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), Must have adequate organ function as indicated by the laboratory values in the table (refer to protocol)., 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, Age =16 and =75 years at the time the Pre-screening Informed Consent/Assent is signed, Diagnosis of advanced (metastatic or inoperable) synovial sarcoma or myxoid liposarcoma / myxoid round cell liposarcoma (Cohort 1 only) 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 (Cohort 1, Cohort 2 and Cohort 3): 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 (Cohort 1 only): confirmation by the presence of the reciprocal chromosomal translocation t(12;16)(q13;p11) or t(12; 22) (q13;q12), Must have previously received either an anthracycline or ifosfamide containing regimen. 1st line metastatic treatment with ADP-A2M4 is permissible if ifosamide +/- doxorubicin has been administered in either the pre-operative (neoadjuvant) or post-operative (adjuvant) primary tumour setting. (Subjects who are intolerant of both anthracycline and ifosfamide must have previously received at least one other type of systemic therapy), Measurable disease according to RECIST v1.1 prior to lymphodepletion., Positive for HLA-A*02:01, HLA-A*02:02, HLA-A*02:03 or 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, 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, Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
排除标准
- •Positive for HLA-A*02:05 in either allele via Adaptimmune designated central laboratory testing: • HLA-A*02:05 in either allele; HLA-A*02 alleles having the same protein sequence as HLA-A*02:05 in the peptide binding domains (p groups) will also be excluded; b) Other alleles may be exclusionary after adjudication with the sponsor, Pregnant or breastfeeding., In the opinion of the Investigator, the subject is unlikely to fully comply with protocol requirements., Received or plans to receive therapy/treatment prior to leukaphereseis or lymphodepleting chemotherapy (refer to table in the protocol), Toxicity from previous anti-cancer therapy must have recovered to = Grade 1 prior to enrollment (except for non-clinically significant toxicities, e.g., alopecia, vitiligo). Subjects with Grade 2 toxicities that are deemed stable or irreversible (e.g. peripheral neuropathy) can be enrolled, History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study, 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 eligible, Symptomatic CNS metastases including leptomeningeal disease. Subjects with a prior history of symptomatic CNS metastasis including leptomeningeal disease must have received treatment (i.e., stereotactic radiosurgery (SRS), whole brain radiation (WBRT) and/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, 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, 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); • 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; • Incipient compression/occlusion of a vital structure (e.g. bronchus; superior vena cava; renal outflow tract) which cannot undergo prophylactic stenting; • COVID-19 infection or a positive COVID-19 RT- PCR test within 28 days of leukapheresis or lymphodepleting chemotherapy. If a subject has a positive COVID-19 test, then 2 subsequent negative tests are required, taken at least 7 days apart, Active i
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