[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphocytic-leukemia-refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphocytic-leukemia-refractory":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100598340","phase-1-a-study-of-ctd402-in-t-alllbl-patients-100598340",false,"NCT07070219","A Study of CTD402 in T-ALL\u002FLBL Patients","A Single-Arm, Open-Label, Multi-Center, Phase 1b\u002F 2 Study to Evaluate the Safety, Efficacy, and Cellular Pharmacokinetic Profile of CTD402 in Participants With Relapsed\u002FRefractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and Lymphoblastic Lymphoma (T-LBL) (TENACITY-01)","TENACITY-01","Key Inclusion Criteria:\n\n1. Male or female, ≥ 12 years of age.\n2. Participants with body weight ≥ 40 kilogram.\n3. Relapsed or refractory T-ALL\u002FLBL is defined as one of the following:\n\n   1. Relapsed or refractory disease after two or more lines of systemic therapy;\n   2. The first relapse occurs within 12 months after first remission;\n   3. Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.\n4. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.\n5. Have eligible HLA-matched related donor (MRD) or unrelated donor (URD), eligible haploidentical donor (HID) or syngeneic donors.\n6. Adequate organ function\n7. Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \\\u003C 16) at screening.\n\nKey Exclusion Criteria:\n\n1. Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome.\n2. Active central nervous system (CNS) involvement\n3. Participants with following cardiac conditions will be excluded:\n\n   1. History of heart failure New York Heart Association (NYHA) class III or IV;\n   2. History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment.\n4. Primary immune deficiency.\n5. Presence of uncontrolled infections.\n6. Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis.\n7. Active or latent hepatitis B virus infection\n8. Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.","ALL","12 Years",{"count":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The goal of the TENACITY-01 clinical trial is to learn if CTD402 UCART is safe and effective for relapsed\u002Frefractory T-ALL\u002FLBL patients.\n\nParticipants with relapsed\u002Frefractory T-ALL\u002FLBL over the age of 12 will be eligible to participate.\n\nParticipants will receive one infusion of CTD402 on Day 0 and will be evaluated for anti-tumor activity by an independent review committee based on the NCCN criteria for T-ALL and the Lugano 2014 criteria for T-LBL.\n\nPatients will be followed for up to 24 months in this study and will be required to enroll under a separate long term follow up protocol to be followed for up to 15 years.",[28,29],"Acute Lymphocytic Leukemia Refractory","Lymphoma, Lymphoblastic",[31,32],"CAR-T Therapy","relapsed\u002Frefractory","RECRUITING","2026-02-04",{"date":36,"type":37},"2026-02-05","ACTUAL",{"date":39,"type":37},"2025-10-07",{"date":41,"type":21},"2028-12-30",{"name":43,"class":44},"BIOHENG THERAPEUTICS US LLC","INDUSTRY",8,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100467396","phase-1-tafasitamab-mor00208-in-pediatric-patients-with-relapsed-or-refractory-acute-b-lineage-leukemia-100467396","NCT05366218","Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia","A Prospective Phase I\u002FII, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia","Anti-CD19-ALL","Inclusion Criteria:\n\n* Age ≥ 3 years and \\\u003C 18 years at enrollment\n* B-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL)\n* Patients must have either\n\n  * underwent a first allogeneic stem cell transplantation after relapse with one of the following very high-risk somatic molecular alterations:\n\n    * KMT2A::AFF1 \\[t(4;11) rearrangement\n    * TP53 alteration (mutation\u002Fdeletion)\n    * low hypodiploidy (\\\u003C40 chromosomes, evident or masked)\n    * TCF3-PBX1 \\[t(1;19)\\]\n    * TCF3::HLF \\[t(17;19)\\] and irrespective of MRD after SCT or\n  * underwent a first allogeneic stem cell transplantation or a CAR T-cell therapy with newly emerging or persistent MRD load posttransplant \u002F post CAR T- cell-treatment or\n  * have received stem cell transplantation without having reached a sufficient molecular remission prior to transplant (defined as MRD ≥10E-4) irrespective of MRD after SCT or\n  * underwent a second or subsequent allogeneic stem cell transplantation irrespective of MRD after SCT\n* Females of childbearing potential (FCBP1) must agree\n\n  * to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 3 months before starting study drug, while participating in the study (including dose interruptions), and for at least 3 months after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe\n  * to abstain from breastfeeding during study participation and 3 months after study drug discontinuation.\n* Males must agree\n\n  * to use a latex condom during any sexual contact with FCBP while participating in the study and for 3 months following discontinuation from this study, even if he has undergone a successful vasectomy\n  * to refrain from donating semen or sperm during study participation and for 3 months after discontinuation from this study treatment.\n\nExclusion Criteria:\n\n* Frank relapse (\\>5% leukemic blasts)\n* Philadelphia chromosome-positive (Ph+) ALL\n* Ejection fraction \\\u003C25% on echocardiography\n* Cystatin C-clearance \\\u003C40ml\u002Fmin\n* Liver function abnormalities with bilirubin \\>4 mg\u002FdL and elevation of transaminases higher than 400 U\u002FL\n* Severe infection (HIV, Chronic active viral hepatitis), tests have to be conducted at screening\n* Acute GvHD III-IV or extensive chronic GvHD\n* The following immunosuppressive drugs (≥ 1 week of administration):\n\nsteroids ≥ 1mg\u002Fkg body weight, cytostatics (except intrathecal\u002F intracerebroventricular application for CNS treatment)\n\n* Application of other experimental therapy modalities in the last 4 weeks\n* Significant psychiatric disabilities, uncontrolled seizure disorders or severe peripheral neuropathy\u002F leukoencephalopathy\n* Signs of autoimmune disease (i.e. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia)\n* Subjects that do not agree to refrain from donating blood while on study drug\n* Concurrent severe or uncontrolled medical disease which by assessment of the treating physician could compromise participation in the study\n* Women during pregnancy and lactation\n* History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.","3 Years","18 Years",{"count":57,"type":21},20,[24,25],"The objective of the trial is to evaluate the safety, clinical toxicity and in vivo immunological effects of MOR00208 in pediatric patients with acute lymphoblastic leukemia who showed newly emerging or persistent MRD after a first stem cell transplantation, received stem cell transplantation without having reached a sufficient molecular remission prior to transplant (defined as MRD ≥10E-4) irrespective of MRD after SCT or underwent a second or subsequent stem cell transplantation irrespective of MRD after SCT.\n\nPart I: to determine the recommended dose of MOR00208 in pediatric patients Part II: to evaluate the time until hematological relapse or increase of MRD",[61,62,28],"ALL, Childhood B-Cell","Acute Lymphoid Leukemia Relapse",[64,65,66],"CD19 positive","refractory to standard treatment","relapse","2026-02-02",{"date":36,"type":37},{"date":70,"type":37},"2023-03-08",{"date":72,"type":21},"2029-02",{"name":74,"class":75},"University Hospital Tuebingen","OTHER",11]