[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620258":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":55,"collaborators":32,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":32,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":32,"enrollmentInfo":66,"targetDuration":32,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":32,"overallStatus":75,"whyStopped":32,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"ImmuneOnco Biopharmaceuticals (Shanghai) Inc.","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"IMM0306 in combination with lenalidomide","EXPERIMENTAL","One treatment cycle consists of 4 weeks (28 days). IMM0306 (Amulirafusp Alfa) will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle.",[13,14],"Drug: IMM0306 2.0 mg\u002Fkg","Drug: Lenalidomide 20 mg",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo in combination with lenalidomide","PLACEBO_COMPARATOR","One treatment cycle consists of 4 weeks (28 days). Placebo will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle.",[20,14],"Drug: Placebo",[22,29,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","IMM0306 2.0 mg\u002Fkg","IV infusion;",[9],[28],"Amulirafusp Alfa",{"type":23,"name":30,"description":25,"armGroupLabels":31,"otherNames":32},"Placebo",[16],null,{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Lenalidomide 20 mg","orally",[9,16],[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Yuqin Song, Professor","CONTACT","010-88196118","SongYQ_VIP@163.com",[44],{"facility":45,"status":32,"city":46,"state":32,"zip":32,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":32},"Beijing Cancer Hospital","Beijing","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},{"type":56,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100620258","phase-3-imm0306-in-combination-with-lenalidomide-vs-placebo-in-combination-with-lenalidomide-in-patients-with-relapsedrefractory-follicular-lymphoma-100620258",false,"NCT07355283","IMM0306 in Combination With Lenalidomide vs Placebo in Combination With Lenalidomide in Patients With Relapsed\u002FRefractory Follicular Lymphoma","A Randomized, Double-Blind, Controlled, Multicenter, Phase III Clinical Study of IMM0306 (Amulirafusp Alfa) for Injection in Combination With Lenalidomide Versus Placebo in Combination With Lenalidomide in Patients With Relapsed\u002FRefractory Follicular Lymphoma","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n2. At least one measurable lesion (as per Lugano 2014 criteria).\n3. Histologically confirmed CD20-positive Follicular Lymphoma, Grade 1, 2, or 3a.\n4. Previously received at least two prior systemic regimens, including at least one line containing an anti-CD20 monoclonal antibody.\n5. Adequate hepatic, hematologic, and renal function.\n6. Expected survival at least 6 months.\n\nExclusion Criteria:\n\n1. Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation.\n2. History of central nervous system (CNS) metastases or active CNS involvement.\n3. History of other malignancy within the past 5 years.\n4. Severe organic cardiovascular or cerebrovascular diseases.\n5. History of severe allergic reactions to any components of the trial drug, any macromolecular protein preparations or monoclonal antibodies.\n6. Previous treatment with anti-CD47 monoclonal antibody\u002FSIRPα fusion protein.\n7. Human immunodeficiency virus (HIV) infection.\n8. Echocardiography examination indicating left ventricular ejection fraction (LVEF) \\\u003C 55%.\n9. Active infection requiring systemic therapy (e.g., fungal, bacterial, viral).","ALL","18 Years",{"count":67,"type":68},198,"ESTIMATED","INTERVENTIONAL",[71],"PHASE3","This study is a randomized, controlled, double-blind, multicenter, phase III clinical study to evaluate the efficacy of IMM0306 (Amulirafusp Alfa)in combination with lenalidomide versus placebo in combination with lenalidomide in patients with Relapsed\u002FRefractory Follicular lymphoma. Primary endpoints are Complete Remission Rate (CRR) and Progression-Free Survival (PFS).",[74],"Relapsed\u002FRefractory Follicular Lymphoma","NOT_YET_RECRUITING","2026-01-25",{"date":78,"type":79},"2026-01-27","ACTUAL",{"date":81,"type":68},"2026-02",{"date":83,"type":68},"2030-10",{"name":5,"class":6},1]