[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-lymphocytic-leukemia-cllsmall-lymphocytic-lymphoma-sll\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-lymphocytic-leukemia-cllsmall-lymphocytic-lymphoma-sll":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100629569","a-study-to-evaluate-mtm-h-001-injection-in-adult-participants-with-relapsed-or-refractory-b-cell-malignancies-100629569",false,"NCT07476378","A Study to Evaluate MTM-H-001 Injection in Adult Participants With Relapsed or Refractory B-cell Malignancies","An Open-label, Single-arm, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Efficacy of MTM-H-001 in the Treatment of Adult Participants With Relapsed or Refractory B-cell Malignancies (Archonc-001)","Archonc-001","Inclusion Criteria:\n\n1. Male or female, aged 18 - 75 years old (inclusive);\n2. The participant or his\u002Fher legally acceptable representative gives consent to this clinical study participation and signs an Informed Consent Form (ICF) indicating their understanding of the objectives and procedures of the clinical study and willingness to participate in the study;\n3. Participants with histopathologically and immunohistochemically confirmed Non-Hodgkin B-cell Lymphoma (B-NHL) according to the 2016 World Health Organization (WHO) classification of tumors of hematopoietic and lymphoid tissues (CLL\u002FSLL diagnosed in accordance with 2018 iwCLL criteria)\n4. Relapsed or refractory disease after receiving at least two prior lines of standard therapy, or relapsed or refractory disease after receiving autologous hematopoietic stem cell transplant (ASCT) (if applicable).\n5. Adequate major organ function, defined as meeting the following criteria:\n\n   1. Hematology: Hemoglobin (Hb) ≥80 g\u002FL; absolute neutrophil count (ANC) ≥1.0×10\\^9\u002FL; and platelet count (PLT) ≥75×10\\^9\u002FL;\n   2. Coagulation: International Normalized Ratio (INR) ≤1.5×Upper Limit of Normal (ULN) and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN;\n   3. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0×Upper Limit of Normal (ULN);\n   4. Serum Total Bilirubin (TBIL) ≤1.5×ULN (except for participants with documented Gilbert's syndrome);\n   5. Blood creatinine (Cre) ≤1.5×ULN, or calculated creatinine clearance (Ccr) ≥50 mL\u002Fmin (using the Cockcroft-Gault formula);\n   6. Cardiac function: Good hemodynamic stability, Left Ventricular Ejection Fraction (LVEF) ≥50%;\n6. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2;\n7. Expected survival \\>3 months;\n8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and agree to use at least one effective contraceptive method throughout the study and within 6 months after the last treatment cycle.\n\nExclusion Criteria:\n\n1. B-NHL participants with a history of Richter's transformation of chronic lymphocytic leukemia (CLL).\n2. Primary central nervous system (CNS) lymphoma, or malignant tumors involving the CNS.\n3. Burkitt's lymphoma\u002Fleukemia, primary mediastinal large B-cell lymphoma (LBCL).\n4. Known history of other malignancies within the past 5 years, excluding cured localized tumors (including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ, etc.);\n5. Active hepatitis B virus (HBV) infection;\n6. Active hepatitis C virus (HCV) infection;\n7. Active human immunodeficiency virus (HIV) infection or a past history of HIV infection;\n8. Uncontrolled active infection requiring intravenous treatment within one week prior to the first dose;\n9. Corrected QT interval using Fridericia (QTcF) is ≥450 ms (male) or ≥470 ms (female) according to the electrocardiography (ECG) examination results at screening;\n10. Currently experiencing or having experienced within the past 6 months any of the following:\n\n    1. Congestive heart failure (New York Heart Association \\[NYHA\\] Class III-IV);\n    2. Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg with medication treatment;\n    3. Myocardial infarction, clinically significant arrhythmias, unstable angina, Torsades de Pointes, left bundle branch block or bifascicular block, coronary\u002Fperipheral artery bypass grafting, congenital long QT syndrome;\n    4. Cerebrovascular accident, transient ischaemic attack;\n    5. Symptomatic pulmonary embolism;\n11. History of any mental disorders (e.g., schizophrenia, bipolar disorder, eating disorders, major depression, or anxiety) as reported by the participant or documented in medical records;\n12. Pregnant or breastfeeding women.","ALL","18 Years","75 Years",{"count":21,"type":22},69,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with relapsed\u002Frefractory (R\u002FR) B-cell malignancies.",[28,29,30,31,32,33],"Lymphoma, Large B-Cell, Diffuse (DLBCL)","Lymphoma, Follicular","Lymphoma, Mantle-Cell","Chronic Lymphocytic Leukemia (CLL)\u002FSmall Lymphocytic Lymphoma (SLL)","Lymphoma, B-Cell, Marginal Zone","Transformed Follicular Lymphoma (TFL)","NOT_YET_RECRUITING","2026-03-12",{"date":37,"type":38},"2026-03-17","ACTUAL",{"date":40,"type":22},"2026-03",{"date":42,"type":22},"2028-06",{"name":44,"class":45},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":59,"conditions":60,"keywords":68,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100488717","phase-1-a-safety-and-efficacy-study-evaluating-ctx112-in-subjects-with-relapsed-or-refractory-b-cell-malignancies-100488717","NCT05643742","A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Subjects With Relapsed or Refractory B Cell Malignancies","Key Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Refractory or relapsed B cell malignancy.\n3. Eastern Cooperative Oncology Group performance status 0 or 1.\n4. Adequate renal, liver, cardiac and pulmonary organ function.\n5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX112 infusion.\n\nKey Exclusion Criteria:\n\n1. Prior allogeneic hematopoietic stem cell transplant (HSCT).\n2. Active or history of central nervous system (CNS) involvement by malignancy.\n3. History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.\n4. Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.\n5. Active HIV, hepatitis B virus or hepatitis C virus infection.\n6. Previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence).\n7. Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX112 infusion or with a nonbiological anticancer drug within 14 days prior to CTX112 infusion.\n8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and\u002For other immunosuppressive therapy.\n9. Women who are pregnant or breastfeeding.",{"count":55,"type":22},120,[57,58],"PHASE1","PHASE2","This is an open-label, multicenter, Phase 1\u002F2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.",[61,62,63,31,64,65,66,67],"B-cell Lymphoma","Non-Hodgkin Lymphoma","B-cell Malignancy","Follicular Lymphoma","Mantle Cell Lymphoma","Marginal Zone Lymphoma","Large B-cell Lymphoma",[69,70,71,72],"CAR T","Non-Hodgkin Lymphoma (NHL)","Lymphoma","Allogeneic","RECRUITING","2025-11-13",{"date":76,"type":38},"2025-11-14",{"date":78,"type":38},"2023-03-10",{"date":80,"type":22},"2030-02",{"name":82,"class":83},"CRISPR Therapeutics AG","INDUSTRY",7]