[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Corregene Biotechnology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100637668","phase-1-a-phase-1-first-in-human-study-of-crpa1a2-a-mage-a1hla-a0201-bispecific-t-cell-engager-in-patients-with-solid-tumors-100637668",false,"NCT07583316","A Phase 1 First-in-Human Study of CRPA1A2, a MAGE-A1\u002FHLA-A*02:01 Bispecific T-Cell Engager, in Patients With Solid Tumors","A Phase I First-In-Human Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of CRPA1A2, a Bispecific T Cell Engager, in Patients With HLA-A*02:01 and MAGE-A1 Positive Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients with a histological and\u002For cytological confirmed locally advanced or metastatic unresectable solid tumor (including but not limited to esophageal squamous cell carcinoma, hepatocellular carcinoma, head and neck squamous cell carcinoma and lung squamous cell carcinoma) who have experienced disease progression following available standard therapy and for whom no further standard treatment options are available.\n2. Patients with confirmed positive expression of MAGE-A1 (H-score ≥1, testing by IHC for FFPE) by central lab.\n3. Patients with positive HLA-A\\*02:01 (confirmed by the central lab).\n4. There must be at least one measurable lesion per RECIST v1.1 criteria. (Lesions that have received radiotherapy previously cannot be considered target lesions unless there is evident progression after radiotherapy).\n5. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.\n6. Life expectancy ≥ 3 months, in the opinion of the investigator.\n7. Has adequate organ function, as demonstrated by laboratory values obtained during the screening period.\n8. Participants (both males and females) of childbearing potential must agree to use highly efficient contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug.\n\nExclusion Criteria:\n\n1. Patients with history of other malignancies (within 2 years prior to signing the ICF) are excluded, except for those with cured stage IB or earlier stage cervical cancer, non-invasive basal cell or squamous cell skin cancer, malignant melanoma in complete remission (CR) for over 10 years, or other malignancies in complete remission (CR) for over 5 years.\n2. Patients with positive HLA-A\\*02:05 (confirmed by the central lab).\n3. Patients with known sensitivity or immediate hypersensitivity to any components of CRPA1A2 or ingredients of CRPA1A2 injection.\n4. Patients who have been exposed to other MAGE-A1 targeted therapy.\n5. With clinically significant cardiovascular diseases, including but not limited to:\n\n   1. History of heart failure, myocardial ischemia or infarction, unstable angina, arrhythmias, or New York Heart Association (NYHA) Class III-IV within the past 6 months or currently.\n   2. With prolonged QT\u002FQTc intervals on the electrocardiogram during the screening period (QTcF: \\> 480 ms).\n   3. Echocardiogram (ECHO) indicates a left ventricular ejection fraction (LVEF) of ≤50% at screening.\n   4. Poorly controlled hypertension at screening (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg) despite pharmacological treatment.\n   5. History of vascular angioplasty, coronary artery bypass grafting, or other cardiac surgical procedures.\n6. With clinically significant active hepatitis B, HBsAg or HBcAb positive and have an HBV-DNA level above the detection limit at screening (i.e., the upper limit of normal values at each research center's laboratory). With the exception for those that have achieved HBV-DNA negativity after antiviral treatment and have received at least 2 weeks of antiviral therapy before the initial dosing. Additionally, they must be willing to continue antiviral therapy for hepatitis B throughout the study period. For patients with hepatocellular carcinoma, HBV DNA must be \\\u003C1000 IU\u002FmL for study eligibility.\n7. Clinically significant active hepatitis C, indicated by positive HCV antibodies and HCV-RNA levels higher than the detection limit at screening (upper limit of normal values).\n8. Positive Treponema pallidum antibodies (TP-Ab) and positive result for nonspecific syphilis antibodies titer (RPR) at screening.\n9. Prior or concurrent therapies\u002Fprocedures that may confound study evaluation or increase risk, including recent participation in another clinical study; recent anticancer therapy, investigational treatment, or invasive investigational medical device use; major surgery without full recovery; prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation; recent autologous hematopoietic stem cell transplantation; or planned transplantation during the study period.\n10. Active, uncontrolled, or clinically significant medical conditions that may increase the risk of study participation or interfere with study assessments, including severe infection; symptomatic or uncontrolled central nervous system or leptomeningeal metastases; clinically significant pulmonary disease (e.g., interstitial lung disease\u002Fpneumonitis); coagulation or bleeding disorders; autoimmune disease or immunodeficiency (including HIV infection); or significant neurologic or psychiatric disorders.\n11. Unresolved toxicities or other conditions considered by the investigator to make the participant unsuitable for the study, including failure to recover adequately from prior anticancer treatment-related toxicities, prior Grade ≥2 ICANS after T-cell engager or CAR-T therapy, clinically significant abnormal laboratory findings, or other severe\u002Funcontrolled acute or chronic diseases, alcohol abuse, or substance misuse.","ALL","18 Years",{"count":19,"type":20},192,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase I, first-in-human, open-label study of CRPA1A2, a bispecific T-cell engager, in participants with HLA-A\\*02:01-positive and MAGE-A1-positive advanced solid tumors. The study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of CRPA1A2, and to identify recommended dose(s) for further evaluation.\n\nThe study consists of 2 parts: a dose escalation part (Part A) and a dose optimization part (Part B). In Part A, participants will receive escalating doses of CRPA1A2 to determine the recommended dose(s) for optimization, with additional backfill cohorts permitted. In Part B, 2 to 3 selected recommended dose(s) will be further evaluated in participants with selected tumor types to better characterize safety and preliminary anti-tumor activity.\n\nCRPA1A2 will be administered by intravenous infusion in 28-day cycles, starting at 0.0003 mg\u002Fkg. Weekly dosing is planned, although alternative dosing schedules may be explored based on emerging data. Treatment will continue until disease progression, intolerable toxicity, initiation of new anti-tumor therapy, other discontinuation criteria are met, or study termination.",[26,27,28,29],"Lung Cancer (Locally Advanced or Metastatic)","Esophagus Cancer","Head and Neck Cancer","Hepatocellular Carcinoma (HCC)",[31,32,33,34,35],"CRPA1A2","Bispecific T-cell engager","Advanced solid tumors","HLA-A*02:01","MAGE-A1","NOT_YET_RECRUITING","2026-05-06",{"date":39,"type":40},"2026-05-13","ACTUAL",{"date":42,"type":20},"2026-05-29",{"date":44,"type":20},"2030-09-30",{"name":46,"class":47},"Corregene Biotechnology Co., Ltd","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100543606","phase-1-crte7a2-01-tcr-t-cells-for-hpv-16-positive-advanced-cancers-100543606","NCT06358053","CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers","A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of CRTE7A2-01 TCR-T Cells in HLA-A*02:01+ Subjects With HPV16 Positive Advanced Cervical, Anal, or Head and Neck Cancers and Other Solid Tumors","Inclusion Criteria:\n\n1\\. Age \\>18 years and 65 years. 2. Patients with advanced solid tumors (such as cervical cancer, head and neck tumors, anal cancer, and other malignancies) who have failed standard treatment confirmed by histology and\u002For cytology, or who are intolerant to such treatment, and for whom there is no effective therapy available after standard treatment failure are considered as end-stage patients. Specifically for:\n\n1. Cervical cancer: a) Patients who have previously failed at least second-line systemic therapy (including at least one platinum-based regimen or anti-angiogenic therapy) and have shown disease progression or intolerance confirmed by pathological or radiological examination during or after the most recent treatment course, and are not amenable to treatment with surgery or radiotherapy, with no standard treatment options currently available for recurrent or metastatic cervical cancer.\n2. Nasopharyngeal cancer: a) Patients who have previously failed at least third-line systemic therapy or are intolerant, not amenable to treatment with surgery or radiotherapy, with no standard treatment options currently available for recurrent or metastatic nasopharyngeal cancer; b) EB virus negative.\n3. Head and neck squamous cell carcinoma: a) Patients who have previously failed at least second-line systemic therapy or are intolerant, with no standard treatment options currently available for recurrent or metastatic head and neck squamous cell carcinoma (non-nasal).\n\n3\\. Confirmation of HPV16 positive and HLA-A\\*02:01 allele. 4. ECOG performance status of 0-1. 5. Estimated life expectancy ≥ 3 months. 6. Patients must have at least one measurable lesion defined by RECIST 1.1. 7. Female patients of childbearing age must undergo a serum pregnancy test within 7 days prior to study treatment and the results must be negative, and are willing to use a very effective and reliable method of contraception from screening through 6 months after the last dose of study treatment.\n\n8\\. The patient must be willing to sign the informed consent form and have a good anticipation of compliance with study procedure.\n\nExclusion Criteria:\n\n1. Patient received any genetically modified T cell therapy.\n2. Patient is being treated with T cell immunosuppressive agent （such as cyclophosphamide, FK506,tripterygium glycosides） or T cell immunoagonist.\n3. Patients received chemotherapy, targeted therapy, immunotherapy, or other investigational agents within 2 weeks and received radiotherapy within 4 weeks before apheresis.\n4. Patients have any organ system function impairment as defined below:\n\n   * leukocytes\\\u003C3.0 x 109\u002FL\n   * absolute neutrophil count \\>1.5 x 109\u002FL\n   * hemoglobin\\\u003C90g\u002FL\n   * platelets \\\u003C100 x 1010\u002FL\n   * lymphocytes\\\u003C0.5 x 109\u002FL\n   * percentage of lymphocytes\\\u003C15%\n   * creatinine\\>1.5×ULN or creatinine clearance \\\u003C50mL\u002Fmin\n   * total bilirubin\\>3×ULN; ALT\u002FAST\\>3×ULN (patients with liver metastasis,\\>5×ULN)\n   * INR\\>1.5×ULN; APTT\\>1.5×ULN\n   * SpO2≤90%\n\n6\\. Patinets has serious medical conditions, disorders, and \u002F or comorbidities, including, but are not limited to: severe heart disease, cerebrovascular disease, epileptic seizures, uncontrolled diabetes (CTCAE 5.0: FBG ≥ 2 grade), active infection, active digestive tract Ulcer, gastrointestinal bleeding, intestinal obstruction, pulmonary fibrosis, renal failure, respiratory failure.\n\n7\\. Patient has a severe cardiovascular disease with 6 months before screening, including, but are not limited to, myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, Heart failure NYHA grade Ⅲ or Ⅳ.\n\n8\\. Left Ventricular Ejection Fractions (LVEF) \\\u003C50%. 9. Patient has a known active brain metastases. 10. Patient has a known myelodysplastic syndrome (MDS) or lymphoma. 11. Patient has a known active autoimmune disease, including , but are not limited to, acquired or congenital immunodeficiency disease, allogeneic organ transplantation, autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease.\n\n12\\. Patient has a known active Hepatitis B or Hepatitis C. 13. Patient has a history of Human Immunodeficiency Virus (HIV) . 14. Patient has a history of syphilis. 15. Pregnant or lactating women. 16. Patient has a known active mental and neurological diseases. 17. The principal investigator judged that it is not suitable to participate in this clinical study.","65 Years",{"count":58,"type":20},24,[23],"A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A\\*02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection.",[62,63,64,65],"Cervical Cancer","Anal Cancer","Head and Neck Cancers","Other Solid Tumors",[67,68,69,70,71,72,73],"HPV","E7","immunotherapy","T cell","Adoptive cell therapy","T cell receptor","TCR","2024-04-06",{"date":76,"type":40},"2024-04-10",{"date":78,"type":20},"2024-04-15",{"date":80,"type":20},"2028-04-30",{"name":46,"class":47},""]