[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-hematological-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-hematological-malignancies":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,70],{"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":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100625607","phase-1-a-study-of-apg-3288-in-relapsedrefractory-blood-cancers-100625607",false,"NCT07424833","A Study of APG-3288 in Relapsed\u002FRefractory Blood Cancers","A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of APG-3288 in Patients With Relapsed\u002FRefractory Hematological Malignancies","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) status ≤ 1 in Part 1 (dose escalation), and ≤ 2 in Part 2 (dose expansion).\n* Part 1 (Dose Escalation): histologically or cytologically confirmed diagnosis of R\u002FR CLL\u002FSLL, DLBCL (including Richter Transformation), MCL, WM, MZL, or FL.\n* Prior systemic therapy: at least 2 prior lines of systemic therapy (including BTK inhibitor for approved indications) and who have failed or are not eligible for available therapies with established clinical benefit.\n* Measurable disease per response criteria specific to the malignant condition.\n* Adequate organ and bone marrow function.\n\nKey Exclusion Criteria:\n\n* Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, with the exception of hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels).\n* Any investigational therapy within 14 days prior to the first dose of study drug or within 5 half-lives of the respective investigational drug (whichever is shorter).\n* Persistent toxicities from prior radiotherapy, targeted therapy, immunotherapy, or chemotherapy agents that have not recovered to Grade \\\u003C2 (except for alopecia or vitiligo).\n* Symptomatic brain metastases due to tumor involvement of the central nervous system (CNS). Patients with CNS tumors who have been treated, are asymptomatic, and who have discontinued steroids (for the treatment of CNS tumors) for \\> 28 days may be enrolled.\n* Use of therapeutic-dose anticoagulants or antiplatelet agents. (Use of low-dose anticoagulants to maintain central venous catheter patency is permitted)\n* Biological growth factors within 7 days prior to the first dose of study drug.\n* Patients who, in the investigator's judgment, have not adequately recovered from prior surgery, or have undergone major surgery within 28 days prior to enrollment, or minor surgery within 14 days prior to enrollment.\n* Significant cardiac disease defined as:\n\n  1. New York Heart Association class III or IV cardiac disease, including pre-existing uncontrolled, clinically-significant arrhythmia, congestive heart failure, or cardiomyopathy.\n  2. Unstable angina, myocardial infarction, or a coronary revascularization procedure within ≤ 3 months prior to initiation of study treatment.\n  3. History of left ventricular ejection fraction \\\u003C 50%.\n  4. Poorly controlled hypertension, or history of poor compliance with antihypertensive drug regimens.\n* Clinically active and uncontrolled symptomatic infection; well-controlled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection may be considered for enrollment.\n* Autoimmune diseases, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation.\n* Concurrent use of QT-prolonging medications or history of torsades de pointes.\n* Concurrent malignancy other than the one being treated in this study with the exception of the following: cured malignancy without recurrence within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancer; completely resected carcinoma in situ of any type.\n* Any severe and\u002For uncontrolled medical condition that, in the investigator's opinion, may compromise the individual's safety or the evaluation of study results.\n* Prior treatment with: BTK degrader treatment or allogeneic stem cell transplant","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase I, multicenter, open-label, two-stage study of APG-3288 monotherapy, aiming to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of APG-3288 administered orally once daily in patients with relapsed\u002Frefractory (R\u002FR) hematologic malignancies.",[26,27,28,29,30,31,32],"Relapsed\u002FRefractory Hematological Malignancies","Relapsed\u002FRefractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Leukemia (CLL\u002FSLL","Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma (DLBCL; Including Richter Transformation)","Relapsed\u002FRefractory Mantle Cell Lymphoma (MCL)","Relapsed\u002FRefractory Waldenström Macroglobulinemia (WM)","Relapsed\u002FRefractory Marginal Zone Lymphoma (MZL)","Relapsed\u002FRefractory Follicular Lymphoma (FL)",[26,34],"APG-3288","NOT_YET_RECRUITING","2026-02-19",{"date":38,"type":39},"2026-02-20","ACTUAL",{"date":41,"type":20},"2026-03",{"date":43,"type":20},"2031-12",{"name":45,"class":46},"Ascentage Pharma Group Inc.","INDUSTRY",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100615568","phase-1-a-phase-i-trial-of-qls2313-injection-in-relapsedrefractory-hematological-malignancies-100615568","NCT07294300","A Phase I Trial of QLS2313 Injection in Relapsed\u002FRefractory Hematological Malignancies","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS2313 for Injection in Patients With Relapsed\u002FRefractory Hematological Malignancies","Inclusion Criteria:\n\n1. Males or females aged ≥ 18 years；\n2. Patients with relapsed\u002Frefractory hematological malignancies, specifically patients with B-cell NHL or CLL\u002Fsmall lymphocytic lymphoma (SLL) as defined by the 2022 World Health Organization (WHO) classification, who are relapsed\u002Frefractory and have no standard of care available as judged by the investigator;\n3. Having a measurable disease defined by appropriate disease response criteria;\n4. Subjects with sufficient organ function prior to the first dose of the investigational drug\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1\n\nExclusion Criteria:\n\n1. Previous treatment with a CD79b\u002FCD3\u002FCD20 trispecific antibody；\n2. Known central nervous system (CNS) involvement；\n3. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\u002Fbone marrow transplantation；\n4. Treatment with autologous stem cell transplantation within 3 months;\n5. Prior genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T cells \\[CAR-T\\] and natural killer cells \\[CAR-NK\\]) within 3 months\n6. Presence of viral, bacterial or uncontrolled fungal infection requiring intravenous drug infusion within 1 week prior to the first dose\n7. Presence of chronic or acute active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV-5 test at screening indicating active infection (positive HBsAg and\u002For positive HBcAb) with HBV-DNA \\> ULN, or positive HCVAb and positive HCV-RNA, allowed for antiviral therapy.",{"count":56,"type":20},124,[23],"This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary antitumor activity of QLS2313 as a monotherapy in patients with relapsed\u002Frefractory hematological malignancies.",[26],"2025-12-08",{"date":62,"type":39},"2025-12-19",{"date":64,"type":20},"2026-01",{"date":66,"type":20},"2028-02",{"name":68,"class":46},"Qilu Pharmaceutical Co., Ltd.",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":69},"100479892","phase-1-study-of-car-t-cell-therapy-in-the-treatment-of-relapsedrefractory-hematological-malignancies-100479892","NCT05528887","Study of CAR-T Cell Therapy in the Treatment of Relapsed\u002FRefractory Hematological Malignancies","Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed\u002FRefractory Hematological Malignancies","Inclusion Criteria:\n\n1. Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy.\n2. Positive expression of specific antigens.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0\\~2.\n4. Adequate organ functions:\n\n   * Serum bilirubin ≤ 35 μmol\u002FL;\n   * Serum aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 2;\n   * Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN);\n   * Brain natriuretic peptide (BNP)\\\u003C80 pg\u002FmL.\n5. Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.\n\nExclusion Criteria:\n\n1. History of allergy to any of the drugs involved in the protocol.\n2. History of cardiac diseases:\n\n   * Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n   * Class III or IV heart failure as defined by the New York Heart Association (NYHA).\n3. History of another malignancy tumor.\n4. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.\n5. Patients with any contraindications to allogeneic hematopoietic stem cell transplantation.\n6. Uncontrolled fungal, bacterial, viral, or other infection.\n7. Female subjects who are pregnant or lactating.","75 Years",{"count":79,"type":20},10,[23],"The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed\u002Frefractory hematological malignancies.",[26,83,84,85],"Lymphoma","Myeloma","Leukemia",[87,88,89,90],"CD19 CAR-T","BCMA CAR-T","CD7 CAR-T","CD123 CAR-T","RECRUITING","2022-09-01",{"date":94,"type":39},"2022-09-06",{"date":96,"type":39},"2021-09-16",{"date":98,"type":20},"2026-06",{"name":100,"class":101},"The Affiliated People's Hospital of Ningbo University","OTHER_GOV"]