[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rr-aml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rr-aml":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100622522","phase-1-first-in-human-fih-trial-of-gen3018-in-relapsed-or-refractory-rr-acute-myeloid-leukemia-aml-or-higher-risk-myelodysplastic-syndrome-hr-mds-100622522",false,"NCT07384715","First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R\u002FR) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)","An Open-Label, Multicenter, First-in-Human Trial of GEN3018 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome","Key Inclusion Criteria:\n\nAll Participants:\n\n* Be at least 18 years of age at the time of signing informed consent form (ICF).\n* Participant's life expectancy at screening is judged to be at least 3 months.\n* Must have fresh bone marrow samples collected at screening.\n* Bone marrow (BM) blasts ≥ 5% at screening.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2.\n* Has acceptable laboratory test results during the screening period\n\nParticipants with R\u002FR AML:\n\n* Relapsed or refractory AML, either de novo or secondary, and must have failed all conventional therapies.\n* Relapsed or refractory to at least one prior line of therapy.\n\nParticipants with R\u002FR HR-MDS:\n\n* Diagnosed with high- or very-high risk MDS according to International Prognostic Scoring System (IPSS-R) (score of \\> 4.5 ie, high or very high) or World Health Organization (WHO) 2022 classification (ie, MDS-IB1 or MDS-IB2).\n* Refractory or relapsed after hypomethylating agents (HMAs) (such as azacitidine or decitabine).\n\nKey Exclusion Criteria:\n\nAll Participants:\n\n* Diagnosis of acute promyelocytic leukemia (APL).\n* Presence of extramedullary AML at screening.\n* Prior autologous or allogenic hematopoietic stem cell transplant (HSCT) within 3 months prior to initiation of trial treatment.\n* Active graft-versus-host disease.\n* History of severe immune-related adverse events.\n* Treatment with anti-cancer agent (eg, small molecule, antibody, chemotherapy, radiation therapy), or major surgery within 2 weeks prior to the first dose of GEN3018.\n\nOther protocol-defined Inclusion and Exclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},78,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The drug that will be investigated in the trial is an antibody, GEN3018. Since this is the first trial of GEN3018 in humans, the main purpose is to evaluate safety. In addition to safety, the trial will determine the recommended GEN3018 dose(s) to be tested in a larger group of participants and assess preliminary anti-tumor activity of GEN3018. GEN3018 will be studied in refractory (resistant to treatment) or relapsed (disease has returned) acute myeloid leukemia (also known as R\u002FR AML) and refractory or relapsed higher-risk myelodysplastic syndrome (also known as R\u002FR HR-MDS). The trial consists of 2 parts:\n\n1. Part 1 Dose Escalation will test increasing doses of GEN3018 to identify a safe dose level to be tested in the next part\n2. Part 2 Dose Refinement will further test the GEN3018 dose(s) determined from the Dose Escalation.\n\nUp to 78 participants may be treated in this trial (up to 60 participants in Part 1; up to 18 participants in Part 2).\n\nFor an individual participant in the trial, the estimated treatment duration will be up to 1 year. Participation in the trial will require regular scheduled visits to the site. At site visits, there will be various tests (such as blood draws) to monitor whether the treatment is safe and effective. Participants will also be contacted every 3 months after treatment ends to monitor how they are doing.\n\nAll participants in the trial will receive active drug (ie, GEN3018); no one will be given placebo.",[26,27,28,29],"R\u002FR AML","R\u002FR HR-MDS","Acute Myeloid Leukemia","Higher-Risk Myelodysplastic Syndrome","RECRUITING","2026-06-01",{"date":33,"type":34},"2026-06-02","ACTUAL",{"date":36,"type":34},"2026-02-16",{"date":38,"type":20},"2030-04-20",{"name":40,"class":41},"Genmab","INDUSTRY",9,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100618842","early-phase-1-clinical-study-of-novel-car-itnk-cells-targeting-cd70-and-cll1-for-refractoryrelapsed-aml-100618842","NCT07336875","Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory\u002FRelapsed AML","Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory\u002FRelapsed Acute Myeloid Leukemia","Inclusion Criteria:\n\n1\\. The patient or their legal guardian voluntarily participates and has signed the informed consent form.\n\n2\\. Age between 18 and 75 years old (inclusive), with no gender restrictions. 3. Diagnosed as having refractory\u002Frelapsed acute myeloid leukemia, meeting one of the following criteria:\n\n1. . Reappearance of leukemic cells in peripheral blood after achieving complete remission, or bone marrow blast count \\> 5% (excluding other causes such as bone marrow reconstitution post-consolidation chemotherapy), or the presence of extramedullary leukemic cell infiltration.\n2. . Ineligible for bone marrow transplantation, or have undergone bone marrow transplantation but failed to achieve long-term remission.\n\n4\\. Expression of both CLL-1 and CD70 targets is confirmed as positive by flow cytometry.\n\n5\\. Patients must have good major organ function:\n\n1. . Liver function: ALT\u002FAST \\\u003C 3 times the upper limit of normal (ULN) and total bilirubin ≤ 34.2 μmol\u002FL.\n2. . Kidney function: Creatinine clearance rate (Cockcroft-Gault method) ≥ 60 mL\u002Fmin.\n3. . Lung function: Oxygen saturation ≥ 95%, with no active pulmonary infection.\n4. . Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; no significant pericardial effusion, and no clinically significant ECG abnormalities.\n\n6\\. Women of childbearing age must have a negative urine\u002Fblood pregnancy test during screening and agree to use contraceptive measures for at least 1 year after infusion. Male subjects with reproductive capacity must agree to use effective barrier contraception for at least 1 year after infusion.\n\n7\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. 8. Expected life expectancy greater than 3 months. 9. The patient is willing to cooperate with the collection of peripheral blood mononuclear cells, medical examinations, and regular follow-up visits.\n\nExclusion Criteria:\n\nThe patient will be excluded if meeting any of the following criteria:\n\n1. Women who are pregnant or breastfeeding.\n2. Presence of uncontrolled fungal, bacterial, treponemal (e.g., syphilis), viral, or other infections.\n3. Active hepatitis B (Hepatitis B virus DNA \\> 500 IU\u002FmL) or a positive Hepatitis C virus RNA (HCV-RNA) test.\n4. Human Immunodeficiency Virus (HIV) infection, or syphilis infection.\n5. Previously received any form of gene therapy.\n6. The patient has an allergic constitution or is allergic to macromolecular biologics such as antibodies or cytokines.\n7. History of clinically significant central nervous system diseases, such as: epilepsy, hemiparesis, aphasia, stroke, severe brain trauma, dementia, Parkinson's disease, cerebellar diseases, or organic brain syndromes.\n8. Uncontrolled psychiatric illness.\n9. A history of drug abuse\u002Faddiction.\n10. Use of prohibited medications:\n\n(1). Hormones: Use of corticosteroids (prednisone ≥ 2 mg\u002Fkg or equivalent \\> 20 mg\u002Fday) within 2 weeks prior to cell collection. Recent or ongoing use of inhaled, topical, or non-absorbable steroids is not an exclusion criterion.\n\n(2). Radiotherapy\u002FChemotherapy:Receipt of radiotherapy or salvage chemotherapy for the study disease within 3 weeks prior to cell collection.\n\n(3). Use of immunosuppressive agents within 4 weeks prior to cell collection. (4). Participation in another clinical trial or receipt of a major non-diagnostic surgical procedure within 4 weeks prior to cell collection.\n\n(5). Use of alemtuzumab within 6 months, or cladribine\u002Fclofarabine within 3 months, prior to cell collection.","75 Years",{"count":52,"type":20},30,[54],"EARLY_PHASE1","The purpose of this clinical trial is to evaluate the safety and efficacy of CAR-ITNK cells therapy targeting CD70 and CLL1 in participants with relapsed\u002Frefractory Acute Myeloid Leukemia. Participants will receive a single infusion of CAR-ITNK cell therapy targeting CD70 and CLL1 and complete follow-ups over the next three years.",[26],[58,59],"CAR-ITNK","CD70&CLL1","NOT_YET_RECRUITING","2026-01-04",{"date":63,"type":34},"2026-01-13",{"date":65,"type":20},"2026-02-28",{"date":67,"type":20},"2029-02-28",{"name":69,"class":70},"Tongji Hospital","OTHER"]