[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ractigen Therapeutics.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,64],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100652739","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-rag-01-as-monotherapy-and-in-combination-with-chemotherapy-in-patients-with-non-muscle-invasive-bladder-cancer-nmibc-100652739",false,"NCT07777848","A Study to Evaluate the Efficacy and Safety of RAG-01 as Monotherapy and in Combination With Chemotherapy in Patients With Non-muscle Invasive Bladder Cancer (NMIBC).","A Randomized, Controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of RAG-01 Monotherapy and RAG-01 in Combination With Chemotherapy in Intermediate\u002FHigh-risk Patients With Non-muscle Invasive Bladder Cancer (NMIBC).","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in this study and provides written informed consent prior to the initiation of any study-specific procedures.\n2. Is aged ≥18 years at the time of signing the informed consent form (ICF).\n3. Has histologically confirmed tumor tissue obtained within 12 weeks prior to the first study treatment, with urothelial carcinoma as the predominant histologic subtype (≥90%), and is classified according to the American Urological Association (AUA) guidelines as follows:\n\n   * Cohort A: high-risk non-muscle-invasive bladder cancer (NMIBC).\n   * Cohort B: intermediate-risk NMIBC.\n4. Regardless of prior bacillus Calmette-Guérin (BCG) treatment, is confirmed before enrollment to be BCG-intolerant, ineligible for BCG, unwilling to receive BCG, or unable to access BCG treatment for any reason.\n5. Has no resectable lesion, as confirmed by cystoscopy and\u002For transurethral resection of bladder tumor (TURBT), within 12 weeks prior to the first administration of study treatment.\n6. Is willing to provide pathological tissue specimens.\n7. Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.\n8. Has adequate hematologic and organ function within 14 days prior to enrollment.\n9. Female participants must agree to use effective contraception during treatment or be surgically sterile or postmenopausal. Women of childbearing potential must have a negative pregnancy test during the screening period; however, pregnancy testing is also required for participants with bilateral tubal ligation. Male participants must be surgically sterile or agree to use effective contraception during treatment. Participants must use contraception from the time of signing the ICF until 3 months after completion of study treatment. The definition of effective contraception will be based on the investigator's judgment.\n\nExclusion Criteria:\n\n1. Low-risk NMIBC.\n2. Very high-risk NMIBC.\n3. Tumors staged as T2 or higher, or urothelial carcinoma of the upper urinary tract or urethra (renal pelvis, ureter, or urethra).\n4. Predominantly non-urothelial histology, including squamous cell carcinoma, adenocarcinoma, or other non-urothelial carcinomas.\n5. Receipt of antitumor intravesical therapy between the most recent transurethral resection of bladder tumor (TURBT) and the first administration of study treatment, except for a single immediate postoperative intravesical chemotherapy instillation.\n6. Receipt of any antitumor therapy within 4 weeks prior to the first administration of study treatment.\n7. Participation in another clinical trial involving an antitumor investigational drug within 4 weeks prior to the first administration of study treatment.\n8. Prior treatment with small nucleic acid-based antitumor agents, p21-targeted antitumor agents, or cyclin-dependent kinase (CDK) inhibitors.\n9. Major surgery within 4 weeks prior to signing the informed consent form (ICF).\n10. History of malignancy within 2 years prior to enrollment, except for curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; or ongoing requirement for antitumor therapy.\n11. Any Grade ≥3 hemorrhage, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0, at any site within 6 weeks prior to enrollment, regardless of whether the event has resolved.\n12. Chronic renal injury or inflammation, or renal injury or inflammation not recovered to Grade ≤1 according to NCI CTCAE version 6.0.\n13. Any of the following within 6 months prior to enrollment: myocardial infarction; severe or unstable angina; coronary or peripheral arterial bypass grafting; symptomatic congestive heart failure; cerebrovascular accident or transient ischemic attack; or pulmonary embolism.\n14. Uncontrolled hypertension.\n15. New York Heart Association (NYHA) Class III or IV heart failure, or left ventricular ejection fraction (LVEF) \\\u003C50%.\n16. Prolonged corrected QT (QTc) interval.\n17. Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or tuberculosis at screening, including HIV antibody positivity; hepatitis B surface antigen (HBsAg) positivity with detectable HBV DNA; or HCV antibody positivity with detectable HCV RNA.\n18. Severe infection within 4 weeks prior to the first administration of study treatment, or active infection of Grade ≥2 per CTCAE requiring systemic antibiotic treatment within 1 week prior to the first administration of study treatment.\n19. Intolerance of or inability to receive intravesical instillation, or inability to retain intravesical study treatment for the duration required by the protocol for any reason.\n20. Anuria, urinary incontinence, or urinary tract obstruction within 4 weeks prior to enrollment.\n21. Persistent gross hematuria despite treatment within 1 week prior to enrollment.\n22. Uncontrolled pleural effusion, pericardial effusion, or ascites.\n23. Severe pulmonary disease of significant clinical relevance.\n24. Confirmed vesicoureteral reflux or bladder perforation.\n25. Any other serious acute or chronic medical condition that, in the investigator's judgment, may increase the risk associated with study participation or study treatment, or may interfere with the interpretation or assessment of study results.\n26. Severe psychological or psychiatric disorder that, in the investigator's judgment, is likely to result in inadequate compliance with study requirements.","ALL","18 Years",{"count":19,"type":20},114,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a randomized, controlled, multicenter clinical study to evaluate the efficacy and safety of RAG-01 monotherapy and in combination with chemotherapy in patients with NMIBC.",[26],"Non-muscle Invasive Bladder Cancer (NMIBC)","NOT_YET_RECRUITING","2026-08-17",{"date":30,"type":31},"2026-08-20","ACTUAL",{"date":33,"type":20},"2026-09",{"date":35,"type":20},"2029-03",{"name":37,"class":38},"Ractigen Therapeutics.","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":5},"100543133","phase-1-a-study-of-rag-01-in-patients-with-non-muscle-invasive-bladder-cancer-nmibc-who-have-failed-bacillus-calmette-gurin-bcg-therapy-100543133","NCT06351904","A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy","A Phase Ⅰ, Open Label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy","Inclusion Criteria:\n\n1. Ability to understand the study and have signed the informed consent form;\n2. Any adult ≥ 18 years old;\n3. Pathologically confirmed high grade NMIBC defined as grade 2 or grade 3 disease;\n4. Expected survival ≥ 6 months;\n5. ECOG PS ≤2;\n6. Sufficient organ functions, as defined below:\n\n   Investigations Hematology Absolute Neutrophil Count (ANC): ≥ 1.5 x 109\u002FL Hemoglobin: ≥ 90 g\u002FL Platelet: ≥ 100 x 109\u002FL Liver Function Serum bilirubin: ≤ 1.25×ULN or 2.5×ULN（with Gilbert syndrome） AST \\& ALT: ≤ 2.5×ULN Renal Function Creatinine Clearance (Cockcroft-Gault equation): ≥ 30 mL\u002Fmin\n7. Subject must be able to tolerate catheterization;\n8. Female subject of childbearing potential and her spouse must use adopt effective contraception (non-pharmacological contraception required) from signing informed consent to within 6 months after the last instillation;\n\nExclusion Criteria:\n\n1. Subject who is allergy to RAG-01 or similar products;\n2. Except for TURBT, the subject received other anti-tumor treatments, and the last administration date is within ≤ 21 days or 5 half-lifes whichever is shorter from the date of signing ICF;\n3. Subject with imaging examination diagnosed extravesical metastasis, including ureter and urethra;\n4. Subject has other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix, basal or squamous cell carcinomas of the skin, or adenocarcinoma of the prostate that has been surgically treated with a post-treatment PSA that is non-detectable;\n5. The following illnesses have not been relieved to CTCAE 0-1:\n\n   1. Uncontrolled acute and chronic infections, such as pneumonia, biliary tract infection, hepatitis B virus infection and hepatitis C virus infection;\n   2. Dyspnea;\n   3. Acute and chronic kidney injury, and inflammation;\n   4. Urinary incontinence;\n   5. Urinary frequency;\n   6. Urinary tract obstruction (except benign prostatic hypertrophy);\n6. Subject could not hold the urine for at least 90 mins due to any reason;\n7. New York Heart Association (NYHA) 3 or 4 grade;\n8. Coronary heart disease related symptoms have not been relieved to CTCAE 0-1, including: myocardial infarction, unstable angina pectoris, congestive heart failure and arrhythmia;\n9. Subject with QTc \\>470 msec.\n10. Cerebrovascular accidents have not been relieved to CTCAE 0-1;\n11. HIV positive; Active hepatitis B or C. For active HBV, it's defined as HBsAg positive with HBV DNA ≥ ULN, for active HCV, it's defined as HCV antibody positive with HCV RNA ≥ ULN, respectively.\n12. Subject is pregnant or lactating during the treatment period;\n13. History of central nervous system or psychiatric disorders, e.g., epilepsy or dementia;\n14. Other severe systemic diseases which might compromise the subject's compliance to the study, e.g., uncontrolled diabetes, gastrointestinal disorders, and renal diseases;\n15. Any other situations which are judged by the investigator, would exposure the subject to unnecessary risk, therefore he\u002Fshe is not eligible.","75 Years",{"count":49,"type":20},72,[51],"PHASE1","This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy.",[54],"Non-Muscle-Invasive Bladder Cancer (NMIBC)","RECRUITING","2025-09-04",{"date":58,"type":31},"2025-09-11",{"date":60,"type":31},"2024-04-03",{"date":62,"type":20},"2028-08-31",{"name":37,"class":38},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":5},"100558843","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-rag-17-in-subjects-with-amyotrophic-lateral-sclerosis-als-with-superoxide-dismutase-type-1-sod1-gene-mutation-100558843","NCT06556394","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RAG-17 in Subjects With Amyotrophic Lateral Sclerosis (ALS) With Superoxide Dismutase Type 1 (SOD1) Gene Mutation","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Pharmacodynamics of RAG-17 in Subjects With Amyotrophic Lateral Sclerosis (ALS) With Superoxide Dismutase Type 1 (SOD1) Gene Mutation","Inclusion Criteria:\n\n1. Voluntarily consents to participate in this study and provides written informed consent prior to the start of any study specific procedures.\n2. ≥ 18 years of age at the time of informed consent.\n3. Diagnosis of possible, laboratory supported probable, probable, or definite ALS according to the World Federation of Neurology El Escorial.\n4. Documented SOD1 mutation.\n5. Forced vital capacity (FVC) ≥50% of predicted value as adjusted for sex, age, and height (measured seated).\n6. If taking riluzole or edaravone, subject must be on a stable dose or ≥30 days prior to Day 1 and expected to remain at that dose until the final study visit.\n\nExclusion Criteria:\n\n1. Documented p.F21C SOD1 mutation.\n2. Treatment with another investigational drug, biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. Specifically, no prior treatment with small interfering ribonucleic acid, stem cell therapy, or gene therapy is allowed.\n3. Current enrollment in any other interventional study.\n4. History of or positive test result for human immunodeficiency virus, hepatitis C virus antibody or hepatitis B virus.\n5. Pregnant or currently breastfeeding.",{"count":72,"type":20},32,[51],"This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RAG-17 in Subjects with Amyotrophic Lateral Sclerosis (ALS) with Superoxide Dismutase Type 1 (SOD1) Gene Mutation",[76],"Amyotrophic Lateral Sclerosis","2025-01-06",{"date":79,"type":31},"2025-01-08",{"date":81,"type":31},"2024-12-24",{"date":83,"type":20},"2026-04",{"name":37,"class":38},""]