[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-mantle-cell-lymphoma-mcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-mantle-cell-lymphoma-mcl":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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},"100599299","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-icp-248-in-subjects-with-relapsed-or-refractory-mantle-cell-lymphoma-apex-06-100599299",false,"NCT07082686","A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)","A Single-arm, Multi-center, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n* ≥ 18 years old.\n* Histopathologically confirmed MCL expressing Cyclin D1 and\u002For t (11;14) chromosomal translocation.Formalin-fixed paraffin-embedded (FFPE) tissues or sections for diagnosis must be provided. It is for the approval of pathological diagnosis by the central pathology laboratory.\n* The patient was diagnosed with relapsed or refractory mantle cell lymphoma, and the previous treatment needs to meet the following requirements:\n\n  * Failure of at least one adequate prior line of anti-CD20-containing therapy;\n  * Failure of at least one adequate prior line of BTK inhibitor (BTKi)-containing therapy.\n* Failure of the last line of therapy.\n* At least one measurable lesion according to the Lugano 2014 criteria,.\n* ECOG performance status of 0-2 .\n\nExclusion Criteria\n\n* Blastoid or pleomorphic mantle cell lymphoma (MCL).\n* Current or prior history of central nervous system (CNS) lymphoma.\n* Prior use of BCL-2 inhibitors (e.g., venetoclax\u002FABT-199, etc.).\n* Autologous stem cell transplantation or cellular therapy within 3 months prior to the first dose of ICP-248.\n* Prior allogeneic hematopoietic stem cell transplantation.","ALL","18 Years",{"count":19,"type":20},75,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single-arm, multi-center, open-label, phase 2 study to evaluate the efficacy and safety of ICP-248 in subjects with relapsed or refractory mantle cell lymphoma.",[26],"Relapsed or Refractory Mantle Cell Lymphoma (MCL)","RECRUITING","2026-04-24",{"date":30,"type":31},"2026-04-27","ACTUAL",{"date":33,"type":31},"2025-08-21",{"date":35,"type":20},"2028-07",{"name":37,"class":38},"Beijing InnoCare Pharma Tech Co., Ltd.","INDUSTRY",29,{"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":51,"conditions":52,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100628340","phase-2-glofitamab-combined-with-lenalidomide-in-high-risk-patients-with-relapsed-or-refractory-mantle-cell-lymphoma-100628340","NCT07460362","Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma","A Single-arm, Open-label, Multi-center Clinical Study of Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With a BTK Inhibitor","Inclusion Criteria:\n\n* • Signed Informed Consent Forms\n\n  * Age: \\>= 18 to 80 years\n  * Eastern Cooperative Oncology Group =\\\u003C 2\n  * Diagnosis of MCL established by histologic assessment\n  * Previously treated with at least one prior line of systemic therapy for mantle cell lymphoma.\n  * Prior therapy have included a BTK inhibitor, including ibrutinib, zanubrutinib, obrutinib, acalabrutinib and various BTKi in clinical trials. BTki exposure is required, which include BTKi failure or intolerance. BTKi failure is defined as progression of disease during BTKi therapy or patients have progressed or relapsed after completing BTK inhibitor therapy\n  * At least one high risk features as classified:\n\n    * Blastoid\u002Fpleomorphic variants ✔ Ki67 ≥50% ✔ TP53 mutation or deletion\n    * Bulky disease (defined as any lesion ≥7.5 cm on the screening computed tomography \\[CT\\] scan）\n    * Patients that did not achieve a CR with their first-line treatment\n    * early disease progression (POD24) ✔ patients with relapse and refractory treatment above 3 lines\n  * Measurable lesions on cross-sectional imaging documented by diagnostic imaging(MRI, CT or PET-CT), （GTD）≥1.5 cm\n  * Adequate liver function : Total bilirubin =\\\u003C 3 x upper limit of normal (ULN) (unless has Gilbert's disease), Aspartate aminotransferase (AST) =\\\u003C 5.0 x ULN, Alanine aminotransferase (ALT) =\\\u003C 5.0 x ULN\n\nExclusion Criteria:\n\n* • Already enrolled in other Ongoing interventional or non-interventional R\u002FR MCL clinical trials;\n\n  * Currently receiving immunosuppressive treatment for other diseases;\n  * Previous treatment with lenalidomide;\n  * Combined with other malignant tumors within 3 years;\n  * The researcher determines that they are not suitable to participate in this study;\n  * Serious mental or neurological disorders that affect informed consent and\u002For the expression or observation of adverse reactions;\n  * Have a history of major or extensive cardiovascular disease, such as New York Heart Association class III or Grade IV heart disease or objective assessment, myocardial infarction, unstable arrhythmia or unstable angina within 6 months before the first cycle;\n  * Recent major surgery (within 4 weeks before the start of the first cycle);\n  * Active autoimmune diseases with poor treatment control;\n  * Any active infection that may affect the safety of the participant, including bacterial, fungal and various viral infections, occurred within 7 days before the first day of cycle 1;\n  * Positive SARS-CoV-2 PCR test within 7 days prior to enrollment\n  * Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology) Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing on Day 1 of every cycle and every 3 months for at least 12 months after the final cycle of study treatment and appropriate antiviral therapy as indicated.\n  * Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing) Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n  * A history of severe deep vein thrombosis event or pulmonary embolism within 6 months\n  * Patient follow-up was not possible.","80 Years",{"count":49,"type":20},43,[23],"A single-arm, open-label, multi-center clinical study of glofitamab combined with lenalidomide in high risk patients with relapsed or refractory Mantle Cell Lymphoma previously treated with a BTK Inhibitor.\n\nPatients will be eligible if they have received one or more prior lines of therapy, one of which must have been a BTKi. Patients will be enrolled according to a Simon two-stage design, with early stop criteria for lack of efficacy.\n\nGlofitamab will be administered intravenously and lenalidomide will be self-administered orally.\n\nObinutuzumab pretreatment will be administered intravenously as 2 doses of 1000 mg prior to glofitamab initiation. The primary endpoint is BOR at the end of induction, evaluated by PET\u002FCT according to Lugano criteria during study enrolment.\n\nThe primary objective is to evaluate the best objective response rate (BOR) at the end of induction of the combination of glofitamab and lenalidomide.",[53,26],"MCL",[55],"Relapsed or Refractory MCL, previously treated with a BTK Inhibitor","2026-03-05",{"date":58,"type":31},"2026-03-10",{"date":60,"type":31},"2025-08-11",{"date":62,"type":20},"2029-12-30",{"name":64,"class":65},"Peking University Third Hospital","OTHER",1]