[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sarcoma-synovial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sarcoma-synovial":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":37,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100462046","phase-1-anti-ny-eso-1-tcr-gene-engineered-lymphocytes-given-by-infusion-to-patients-with-ny-eso-1--expressing-metastatic-cancers-100462046",false,"NCT05296564","Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers","A Phase I\u002FII Dose Escalation, Safety and Efficacy Study of Anti-NY-ESO-1 T Cell Receptor (TCR)-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers","Inclusion Criteria:\n\n1. Have histologically or cytologically confirmed diagnosis of neoplasia\n2. Measurable (per RECIST v1.1 criteria) metastatic cancer or locally advanced refractory\u002Frecurrent malignancy not amenable to curative treatment. Lesions previously irradiated may be considered measurable only if growth has been documented since local treatment completion.\n3. The tumor expresses ESO as assessed immunohistochemistry of resected tissue. To this end, archived tumor tissue suitable for analysis must be available or re-biopsy performed on study. Tissue staining must encompass more than 10% of tumor section.\n4. Patients must have previously either (1) received at least first-line or second-line standard therapy for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease), intolerable or have recurred or (2) Recurred within 6 months of adjuvant systemic therapy known to be active also in the metastatic setting.\n5. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n6. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).\n7. Age ≥ 18 years and ≤ 70 years.\n8. Patient is able to understand and willing to sign a written informed consent.\n9. Clinical performance status of ECOG 0, 1 or 2.\n10. HLA-A\\*0201or A\\*0206 positive.\n11. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment.\n12. Women of child-bearing potential must have a negative pregnancy test.\n13. Serology: Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n14. Hematology\n\n    * ANC \\> 1500\u002Fmm3 without the support of filgrastim\n    * WBC ≥ 3000\u002Fmm3\n    * Platelet count ≥ 100,000\u002Fmm3\n    * Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n15. Chemistry\n\n    * Serum ALT\u002FAST ≤ 2.5 x ULN\n    * Creatinine clearance ≥40ml\u002Fmin\n    * Total bilirubin ≤ 1.5 mg\u002FdL, except in patients with Gilbert's Syndrome, who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    * INR \\\u003C 1.5\n\nExclusion Criteria:\n\n1. Women of child-bearing potential who are pregnant or breastfeeding.\n2. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).\n3. Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses\n4. Concurrent systemic steroid therapy, not including replacement therapy or treatment with prednisone up to 10mg daily or its equivalent. Or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention.\n5. History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n6. Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months.\n7. Subjects unable to maintain normal oxygen saturation level in room air.\n8. Subjects who have had a venous thromboembolic event requiring anticoagulation and who meet any of the following criteria:\n\n   * Have been on a stable dose of anticoagulation for \\\u003C 1 month (except for acute line insertion induced thrombosis).\n   * Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days or are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).\n9. Has a known additional malignancy within the last 3 years. Exceptions include early stage cancers (carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy).\n10. LVEF ≤ 40%\n11. Documented FEV1 ≤ 60% predicted tested in patients with:\n\n    * A prolonged history of cigarette smoking (≥ 20 pack-year smoking history, with cessation within the past two years).\n    * Symptoms of respiratory dysfunction.\n12. Patients who are at the time of study initiation receiving any other investigational agents.\n13. Carcinomatosis meningitis or other brain involvement exceeding that allowed above.\n14. Has received live vaccine within 30 days before the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.","ALL","18 Years","70 Years",{"count":20,"type":21},3,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","A Phase I\u002FII Dose Escalation, Safety and Efficacy Study of HBI 0201-ESO TCRT (anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes) Given by Infusion to Patients with NY-ESO-1 -Expressing Metastatic Cancers",[28,29,30,31,32,33,34,35,36],"Sarcoma, Synovial","Sarcoma,Soft Tissue","Melanoma Stage IV","Triple Negative Breast Cancer","Metastatic Cancer","Non Small Cell Lung Cancer","Bladder Urothelial Carcinoma","Neuroblastoma, Metastatic","Ovary Cancer",[38,39,40,41],"NY-ESO-1","TCR","adoptive transfer","retroviral transduction","RECRUITING","2025-09-29",{"date":45,"type":46},"2025-10-02","ACTUAL",{"date":48,"type":46},"2022-04-01",{"date":50,"type":21},"2027-12-30",{"name":52,"class":53},"Hadassah Medical Organization","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":68,"conditions":69,"keywords":77,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":54},"100598091","phase-1-sequential-infusion-of-cd146-targeted-and-her2-targeted-car-t-cells-in-patients-with-advanced-sarcomas-100598091","NCT07066982","Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas","A Phase 1\u002F2 Open-Label, Multicenter Trial of Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas","BAH2573-103","Inclusion Criteria:\n\n* Expected survival time ≥3 months;\n* Diagnosis: Histologically or cytologically confirmed sarcoma (soft tissue or bone sarcoma), that is metastatic, locally advanced, or refractory to standard therapy. This may include osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, leiomyosarcoma, or other high-grade sarcomas. Patients must have evidence of measurable disease as per RECIST or applicable criteria.\n* Prior Treatment: Patients should have received and progressed on or not be candidates for standard first-line treatments. There is no limit on number of prior lines of therapy, but at least one prior systemic therapy for sarcoma is typically required (unless no standard therapy exists for the subtype). A minimum wash-out period (e.g. 2 weeks) from previous treatments (chemotherapy, radiation, or other immunotherapy) is required before lymphodepletion.\n* Age and Performance Status: Participants age 12 years and older (both adolescent and adult patients are eligible; for minors, legal guardian consent is required). Upper age limit of \\~75 years, or as determined by medical fitness. ECOG performance status 0-1 (or Karnofsky ≥70% for pediatric patients), indicating subjects are ambulatory and able to perform light work.\n* Organ Function: Adequate organ function to undergo cytotoxic chemotherapy and cell transfer therapy, including: cardiac ejection fraction ≥50%; baseline oxygen saturation \\>92% on room air; adequate bone marrow reserves (absolute neutrophil count ≥1.0×10\\^9\u002FL, platelets ≥75×10\\^9\u002FL, hemoglobin ≥8 g\u002FdL), hepatic function (e.g. bilirubin ≤1.5× ULN, AST\u002FALT ≤2.5× ULN), and renal function (e.g. creatinine clearance ≥50 mL\u002Fmin or age-appropriate normal).\n* Tumor Antigen Expression: Expression of CD146 and\u002For HER2 in the tumor is recommended (as assessed by immunohistochemistry or flow cytometry on a tumor sample). Note: At least one of the target antigens (CD146 or HER2) should be present on the tumor; if feasible, patients should have tumor tissue tested for these markers. (In cases where testing is unavailable, enrollment may proceed based on histology known to often express these targets, per investigator judgment.)\n* Consent: Ability to understand and provide written informed consent (or assent for minors with consent of legal guardian). Patients (or guardians) must be willing to comply with trial procedures and follow-up.\n\nExclusion Criteria:\n\n* Recent Therapies: Prior treatment with any CAR-T cell therapy or other gene-modified T-cell therapy is excluded. Also exclude patients who received any investigational drug, immunotherapy (e.g. checkpoint inhibitor), or major surgery within a certain interval (e.g. 4 weeks) prior to enrollment. Concurrent enrollment in another interventional clinical trial is not allowed.\n* Recent Therapies: Prior treatment with any CAR-T cell therapy or other gene-modified T-cell Infections: Active uncontrolled infection, including active hepatitis B or C infection, or HIV infection with uncontrolled viral load. Patients must not have evidence of active tuberculosis or other severe infections. All patients will be screened for HBV, HCV, and HIV at baseline.\n* Immunosuppression: Use of systemic immunosuppressive medications (such as chronic corticosteroids at \\>10 mg prednisone daily or equivalent) within 7 days prior to leukapheresis. (Physiologic replacement doses of steroids are permitted.) Patients with a history of allogeneic stem cell transplant or solid organ transplant are excluded (due to the need for immunosuppression and risk of graft-versus-host or graft rejection).\n* Medical Comorbidities: Any significant uncontrolled medical condition that would, in the investigator's judgment, make the patient an unsuitable candidate for CAR-T therapy. For example: active autoimmune diseases requiring immunosuppression, clinically significant heart failure (NYHA class III-IV), unstable angina or myocardial infarction within 6 months, severe chronic respiratory disease requiring supplemental oxygen, or psychiatric conditions that would interfere with study participation and follow-up.\n* Pregnancy\u002FBreastfeeding: Women who are pregnant or breastfeeding are excluded due to unknown risks of the treatment to a fetus or infant. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception during the study and for a suitable period after CAR-T infusion (e.g. 1 year), given the potential for sustained CAR T-cell activity. A negative serum pregnancy test is required for females of childbearing potential before starting lymphodepletion.","21 Years","90 Years",{"count":66,"type":21},60,[24,25],"This is an open-label, non-randomized, multicenter Phase 1\u002F2 trial evaluating a dual CAR-T cell therapy targeting CD146 and HER2 in patients with advanced sarcoma. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by sequential infusion of autologous CD146-specific and HER2-specific CAR-T cells. The Phase 1 portion will employ a dose-escalation design to assess safety and determine the recommended Phase 2 dose, while the Phase 2 expansion will evaluate preliminary efficacy (tumor response and survival outcomes). Approximately 40 patients (children and adults) with relapsed or refractory sarcomas will be enrolled across multiple centers. All participants will be followed for up to 36 months to monitor dose-limiting toxicities, objective response rates, progression-free survival, overall survival, and long-term safety.",[70,71,72,29,73,28,74,75,76],"Sarcoma","Sarcoma, Kaposi","Sarcoma, Ewing","Sarcoma of Bone and Connective Tissue","Sarcoma Metastatic","Sarcomas, Germinoblastic","Sarcoma of Bone",[70,78,79,80,76],"CD146","HER2","CAR-T","2025-07-04",{"date":83,"type":46},"2025-07-15",{"date":85,"type":46},"2025-05-29",{"date":87,"type":21},"2028-12-28",{"name":89,"class":53},"Essen Biotech"]