[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia-refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia-refractory":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,49,83,107,134,160,192,214,235,258,280,306,328,349,373,395,420,440],{"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":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100577747","phase-2-intensity-modulated-total-marrow-irradiation-in-fully-human-leukocyte-antigen-hla-matched-and-partially-hla-mismatched-allogeneic-transplantation-patients-with-high-risk-acute-myeloid-leukemia-aml-chronic-myeloid-leukemia-cml-and-myelodysplastic-syndrome-mds-100577747",false,"NCT06802315","Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)","A Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Myeloablative Fludarabine\u002FBusulfan and Post-Transplant Cyclophosphamide (PTCY) for Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk AML, CML, and MDS","BMT-13","Inclusion Criteria:\n\n* 1\\. Age 18-65 years.\n* 2\\. Patients with CML, AML, or MDS who meet one of the following criteria: 2a. Relapsed or refractory AML (including AML in CR2) 2b. Poor-risk AML in first remission, with remission defined as \\\u003C5% bone marrow blasts morphologically:\n* AML arising from MDS, a myeloproliferative disorder, or secondary AML\n* Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and\u002For ZRSR2\n* Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (\\> 3 abnormalities), inv (3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7. 2c. Primary refractory disease 2d. MDS with at least one of the following poor-risk features:\n* Poor-risk cytogenetics including 3q abnormalities, 7\u002F7q minus or complex cytogenetics (\\>3 abnormalities).\n* Current or previous INT-2 or high IPSS score.\n* Treatment-related MDS.\n* MDS diagnosed before the age of 21 years.\n* Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy.\n* Life-threatening cytopenias, including those requiring regular PRBC or platelet transfusions. 2e. CML with a history of accelerated or blast phase.\n\nExclusion Criteria:\n\n* 1\\. Presence of significant co-morbidity as shown by:\n* 1a. Left ventricular ejection fraction \\\u003C 50%\n* 2b. Creatinine clearance \\\u003C30ml\u002Fmin.\n* 3c. Bilirubin \\> 2.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \\> 5 x ULN.\n* 4d. FEV1 and FVC \\\u003C 50% of predicted or DLCO \\\u003C50% of predicted once corrected for anemia.\n* 5e. Karnofsky score \\\u003C70\n* 6f. Active viral hepatitis or HIV infection.\n* 7g. Cirrhosis.\n* 2\\. Pregnancy or breast feeding\n* 3\\. Patients unable to sign informed consent.\n* 4\\. Patients previously received radiation to \\>20% of bone marrow-containing areas.","ALL","18 Years","65 Years",{"count":21,"type":22},38,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The study is a Phase II clinical trial. Patients will receive intensity-modulated total marrow irradiation (TMI) at a dose of 9 Gray (Gy) with standard myeloablative fludarabine intravenous (IV) and targeted busulfan (FluBu4) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (GVHD) prophylaxis will include Cyclophosphamide on Day +3 and +4, tacrolimus, and mycophenolate mofetil.",[28,29,30,31],"Acute Myeloid Leukemia, Relapsed, Adult","Acute Myeloid Leukemia Refractory","Chronic Myeloid Leukemia - Accelerated Phase","Myelodysplastic Syndromes",[33,34,35],"Total Marrow Irradiation","Stem Cell Transplant","Allogenic Transplant","RECRUITING","2026-06-23",{"date":39,"type":40},"2026-06-26","ACTUAL",{"date":42,"type":40},"2025-02-04",{"date":44,"type":22},"2032-03",{"name":46,"class":47},"University of Illinois at Chicago","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100517416","phase-1-a-study-of-cd371-ysnvzil-18-car-t-cells-in-people-with-acute-myeloid-leukemia-100517416","NCT06017258","A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia","Phase I Trial of CLEc12a (CD371) Targeted ArmoRed Immune Effector Cells in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia (CLEAR-AML)","Inclusion Criteria:\n\nSubject Inclusion: Collection of T cells (Part A)\n\n* History of CD371+ AML\n\n  * Any disease status is eligible for collection\n  * Expression of CD371 at any level on AML blasts (any method of detection including IHC and\u002For flow cytometry)\n* Age\u002FWeight\n\n  * Pediatrics: ≥ 1 year and ≥ 10kg for collection\n  * Adults: no limit on age\u002Fweight for collection\n* Patients with history of allo-HCT are eligible for collection if:\n\n  * ≥ 100 days post-transplant\n  * no evidence of active GVHD\n  * off any immunosuppressive agents for 30 days prior to collection (physiologic dose of corticosteroids is acceptable)\n\nSubject Inclusion: Treatment with CD371-specific\u002FYSNVz\u002FIL-18 CAR T cells (Part B)\n\n* Relapsed\u002FRefractory CD371+ AML (meeting criteria defined below) for primary refractory AML, late first relapse, and\u002For advanced disease:\n\n  o Primary refractory AML: Patients are eligible from disease perspective in the event of failure to achieve a CR, CRh or CRi after one or more of the following regimens:\n* Two or more courses of standard intensive induction chemotherapy (e.g., cytarabine and daunorubicin given as \"7+3,\" MEC, HiDAC, FLAG+idarubicin, etc.);\n* Two or more cycles of venetoclax in combination with one of the following (azacitidine OR decitabine OR low-dose cytarabine), with or without other agents;\n* Six or more cycles of azacitidine monotherapy OR four or more courses of decitabine monotherapy\n\n  * Early first relapse: Patients are eligible from disease perspective in the event of first morphologic relapse or new extramedullary disease less than 12 months after previously having achieved CR, CRh, or CRi following AML-directed therapy\n  * Late first relapse: Patients with first morphologic relapse or new extramedullary disease ≥12 months after previously having achieved CR, CRh, or CRi following AML-directed therapy may respond to intensive re-induction using the initial induction regimen and not eligible from a disease perspective unless the treating investigator feels the patient is unlikely to benefit from repeating the initial induction regimen (for example, relapse occurring 12 months into CR on continuous azacitidine\u002Fvenetoclax therapy), in which case the rationale for considering enrollment must be clearly documented and risks, benefits, and alternatives discussed with the patient.\n  * Advanced disease: Patients are eligible from disease perspective in the event of relapsed AML refractory to reinduction therapy, relapse following alloHCT, or second or later relapse.\n  * Disease eligibility considerations for all patients: Patients with relapsed or refractory AML with susceptible mutations for which there is an FDA approved therapy (for example, IDH1 mutation, ivosidenib; IDH2 mutation, enasidenib; FLT3-ITD\u002FTKD, gilteritinib) are not eligible from a disease perspective unless they meet one or more of the below criteria:\n* Failure to achieve CR, CRh, or CRi following therapy with one or more targeted therapies for relapsed or refractory AML directed to the actionable mutation(s);\n* Intolerance of one or more targeted therapies for relapsed or refractory AML directed to the actionable mutation(s);\n* Treating investigator feels the patient would be unlikely to benefit from FDA-approved targeted therapy based on disease characteristics, in which case the rationale for considering enrollment must be clearly documented and risks, benefits, and alternatives discussed with the patient Age: any age is eligible for treatment if eligible for collection\n\n  o The first 3 patients in the first dose cohort must be ≥ 16 years of age, while the first 2 patients in subsequent cohorts must be ≥ 16 years of age (see Section 10.4)\n* Adequate performance status:\n\n  * Age ≥ 16 years: ECOG ≤ 1 or Karnosfsky ≥ 60\n  * Age \\\u003C 16 years: Lansky ≥ 60\n* Patients with history of allo-HCT are eligible for treatment if:\n\n  * ≥ 100 days post-transplant\n  * no evidence of active GVHD\n  * off any systemic immunosuppressive agents for 30 days prior to treatment (physiologic dose of corticosteroids is acceptable)\n  * Treating physician considers the patient to be a candidate for second alloHCT\n* Identification of a suitable donor\u002Fsource for alloHCT as determined by the treating physician.\n* Adequate organ function is required, defined as follows:\n\n  * Hepatic: Serum total bilirubin ≤ 1.5 mg\u002FdL, unless benign congenital hyperbilirubinemia or unless thought to be disease related.\n  * Hepatic: ALT and AST \\\u003C 3 times the upper limit of normal unless thought to be disease-related.\n  * Renal: serum creatinine \\\u003C 2.0 mg\u002F100 ml (\\> 18 years) or ≤ 2.5 x institutional upper limit of normal (ULN) for age\n* If serum creatinine is outside the normal range, then CrCl \\> 40 mL\u002Fmin\u002F1.73m2 (calculated or estimated) or GFR (mL\u002Fmin\u002F1.73m2) \\> 40% of predicted normal for age.\n\nNormal GFR by Age Age: 1 week \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 40.6 + \u002F - 14.8 Age: 2 - 8 weeks \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 65.8 + \u002F - 24.8 Age: \\> 8 weeks \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 95.7 +\u002F- 21.7 Age: 2 - 12 years \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 133 +\u002F- 27 Age: 13 - 21 years (males) \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 140 +\u002F- 30 Age: 13 - 21 years (females) \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 126.0 + \u002F - 22.0 Abbreviations: GFR, glomerular f filtration rate; SD, standard deviation\n\n* Greater than 2 years old: Normal GFR is 100 mL\u002Fmin\u002F1.73m2.\n* Infants: GFR must be corrected for body surface area.\n\n  * Cardiac: LVEF ≥ 50% by MUGA or resting echocardiogram.\n  * Pulmonary: Adequate pulmonary function as assessed by ≥ 92% oxygen saturation on room air by pulse oximetry\n\nExclusion Criteria:\n\nSubject Exclusion: Collection of T cells (Part A)\n\n* Pregnant or lactating women; women of childbearing age, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while receiving study treatment and for at least 12 months after all treatment is finished\n* Sexually active males, unless they are willing to use a condom during intercourse while receiving study treatment and for at least 12 months after all treatment is finished\n* Radiographically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥ 5\u002Ful WBC in CSF). Subjects with adequately treated CNS leukemia are eligible.\n* Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject\n* Impaired cardiac function (LVEF \\\u003C 50%) as assessed by ECHO or MUGA scan\n* Patients with following cardiac conditions will be excluded:\n\n  * New York Heart Association (NYHA) stage III or IV congestive heart failure\n  * Myocardial infarction ≤ 6 months prior to enrollment\n  * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n* Positive serologic test results for HIV\n* Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.\n* Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR\n* Patient\u002Fparent\u002FLAR unable to give informed consent\u002F\n\nSubject Exclusion: Treatment with CD371-specific\u002FYSNVz\u002FIL-18 CAR T cells (Part B)\n\n* Bridging chemotherapy occurring \\\u003C 1 week prior to administration of LDC\n\n  o Exception: hydroxyurea can be continued up to 72 hours prior to leukapheresis or 24 hours prior to LDC\n* Pregnant or lactating women\n* Radiographically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥ 5\u002Ful WBC in CSF). Subjects with adequately treated CNS leukemia are eligible.\n* Isolated extramedullary disease\n* Lack of a suitable donor\u002Fsource for allogeneic HSCT as determined by the treating physician.\n* Patients with prior alloHCT are allowed as long as alloHCT occurred ≥100 days prior to date of treatment with CD371-specific\u002FYSNVz\u002FIL-18 CAR T cells and as long as the patient is without ongoing requirement for systemic graft-versus-host therapy\n* Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject\n* Impaired cardiac function (LVEF \\\u003C 50%) as assessed by ECHO or MUGA scan.\n* Patients with following cardiac conditions will be excluded:\n\n  * New York Heart Association (NYHA) stage III or IV congestive heart failure\n  * Myocardial infarction ≤ 6 months prior to enrollment\n  * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n* Positive serologic test results for HIV.\n* Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.\n* Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR\n* Active second malignancy that requires systemic treatments, with the exception of malignancy treated with curative intent and without evidence of disease for \\> 2 years before screening\n* Patient\u002Fparent\u002FLAR unable to give informed consent\n* Any other condition\u002Fissue which, in the opinion of the treating physician, would make the patient ineligible for the study; conditions that in the Principal Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.","1 Year",{"count":58,"type":22},15,[60],"PHASE1","The purpose of this study is to find out whether CD371-YSNVZ-IL18 CAR T cells are safe, and to look for the highest dose of CD371-YSNVZ-IL18 CAR T cells that cause few or mild side effects in participants.",[63,64,65,66,29],"Refractory Acute Myeloid Leukemia","Relapsed Acute Myeloid Leukemia","Acute Myeloid Leukemia","Acute Myeloid Leukemia, in Relapse",[63,64,65,66,29,68,69,70,71,72,73],"ArmoRed","CLEAR-AML","CLEc12a","CD371","Memorial Sloan Kettering Cancer Center","23-016","2026-06-18",{"date":76,"type":40},"2026-06-22",{"date":78,"type":40},"2023-09-01",{"date":80,"type":22},"2026-12-17",{"name":72,"class":47},7,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":82},"100593789","phase-1-a-study-of-natural-killer-cells-in-combination-with-atezolizumab-in-people-with-acute-myelogenous-leukemia-100593789","NCT07011004","A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia","Phase I Study of Cytokine Induced Memory-Like Natural Killer Cells Combined With Atezolizumb in Subjects With Relapsed or Refractory Acute Myelogenous Leukemia","Inclusion Criteria:\n\nDisease specific inclusion criteria:\n\n* Subjects must have histologically confirmed acute myeloid leukemia that meets any of the following criteria:\n\n  * Refractory to at least two attempts at prior induction therapy. An attempt is defined as either a single cycle of combination chemotherapy such as daunorubicin\u002Fanthracycline OR a single monthly cycle of a hypomethylating agent with venetoclax.\n  * Patients with FLT3-ITD or -TKD mutations must have received at least one commercially available inhibitor of FLT3.\n  * Patients with NPM1 mutation or rearrangements of MLL must be refractory to revumenib.\n  * Patients with mutations in IDH1 or IDH2 must be refractory to at least one commercially available inhibitor of IDH1 or IDH2, respectively.\n  * Relapsed AML when relapse occurred within 6 months of achieving an initial complete remission.\n  * Patients must have either failed prior FDA approved agents or, in the opinion of the treating physician, have a sufficiently low probability of response to existing FDA approved agents to warrant treatment on an investigational protocol.\n\nOther inclusion criteria:\n\n* Patients aged 18 through 70 years old are eligible.\n* Must have an available, haplotype mismatched related individual that meets criteria for cell donation according to the FACT guidelines.\n* Patients must have Karnofsky performance status ≥70%.\n* Adequate cardiac function as defined as a systolic LV ejection fraction ≥50% at rest and absence of New York Heart Association stage III or IV congestive heart failure.\n* Adequate pulmonary function as defined as a resting SpO2 ≥ 92% on room air at rest.\n* Serum bilirubin ≤ 5 mg\u002FdL.\n* AST and ALT ≤ 2.5x ULN unless thought to be disease related.\n* Estimated or measured creatinine clearance \\> 50 mL\u002Fmin.\n* Subjects must be free from all systemic immune suppression for at least 4 weeks prior to the start of intended therapy.\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs, as defined below: Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C1% per year during the treatment period and for 5 months after the final dose of atezolizumab. Women must refrain from donating eggs during this same period.\n* Negative HIV test at screening.\n* Negative hepatitis B surface antigen (HBsAg) test at screening OR positive HBsAg is allowed if a negative HBcAb or a negative quantitative hepatitis B virus (HBV) (DNA \\\u003C 500 IU\u002FmL) assay are documented.\n* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening The HCV RNA test must be performed for patients who have a positive HCV antibody test.\n* For patients receiving therapeutic anticoagulation: Stable anticoagulant regimen for 2 weeks prior to enrollment.\n* Timing of treatment relative to prior therapies:\n\n  * Bridging therapy with hydrea is allowed but is required to be tapered off prior to NK infusion.\n  * Any experimental biological treatments must be discontinued for at least 5 half-lives prior to initiation of study therapy.\n  * Patients must be \\>5 half-lives from receipt of other cytotoxic or targeted therapy.\n\nExclusion Criteria:\n\n* Prior allogeneic hematopoietic cell transplantation.\n* Subjects with active\u002Funcontrolled CNS leukemia. Subjects with prior CNS disease must have no detectable evidence of CSF disease for at least 4 weeks prior to enrollment.\n* Subjects requiring systemic immunosuppression for any indication are excluded.\n* Significant cardiovascular disease, as defined by:\n\n  * New York Heart Association Class II or greater congestive heart failure.\n  * Myocardial infarction, cerebrovascular accident, or other arterial vascular disease within 6 months prior to initiation of study treatment\n  * Unstable arrhythmia\n  * Unstable angina\n* Subjects with isolated extramedullary disease without evidence of bone marrow involvement by immunohistochemistry.\n* Female patients who are pregnant or breast-feeding or intend to become pregnant during study treatment or within 5 months after the final dose of atezolizumab. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment with atezolizumab.\n* Severe or uncontrolled infection prior to initiation of study treatment.\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, excluding prophylactic antimicrobial agents.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\>12 mg\u002FdL, or corrected calcium greater than ULN)\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti-phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all following conditions are met:\n\n    * Rash must cover \\\u003C 10% of body surface area.\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids.\n    * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n* Persons who do not meet the age and organ function criteria specified above.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.\n\nDonor Inclusion Criteria:\n\n* Donors must be eligible for apheresis according to standard FACT guidelines.\n* Donors must not have an HLA genotype reactive against anti-HLA antibodies in the recipient.","70 Years",{"count":5,"type":22},[60],"The researchers are doing this study is to find the highest dose of cytokine-induced memory-like (CIML) natural killer (NK) cells in combination with the drug atezolizumab that causes few or mild side effects in people with relapsed\u002Frefractory acute myelogenous leukemia (AML). The researchers will also look at whether the treatment combination works against participants' cancer.",[29,66],[96,97,98],"Atezolizumab","CIML-NK (Cytokine Induced Memory-Like Natural Killer Cells)","24-356","2026-06-16",{"date":101,"type":40},"2026-06-17",{"date":103,"type":40},"2025-05-30",{"date":105,"type":22},"2028-05",{"name":72,"class":47},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":115,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":21},"100551356","master-framework-for-relapse-or-refractory-acute-myeloid-leukemia-100551356","NCT06459024","Master Framework For Relapse or Refractory Acute Myeloid Leukemia","Master Framework For Relapse or Refractory Acute Myeloid Leukemia- IMPACT STREAM - A Prospective Observational Study of Treatment Outcomes","IMPACT STREAM","Inclusion Criteria:\n\n* Patients with AML diagnosis according to WHO2022 or ICC2022\n* Treatment failure (i.e. relapse, refractory or progression, including MRD) according to ELN2022 criteria\n* Participant or his\u002Fher legal representative is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Patients included in clinical trials may be enrolled except where otherwise specified in the experimental protocol.","6 Years",{"count":117,"type":22},4000,"OBSERVATIONAL","This is an observational (non-interventional), prospective, cohort study that will collects data from patients diagnosed with relapsed or refractory acute myeloid leukemia afferent to the participanting clinical sites",[66,29],[122,123,65,124],"Relapsed","Refractory","Framework","2026-06-09",{"date":127,"type":40},"2026-06-10",{"date":129,"type":40},"2024-06-28",{"date":131,"type":22},"2032-07",{"name":133,"class":47},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":159},"100544732","phase-1-a-study-to-investigate-apl-4098-alone-and-in-combination-in-adults-with-aml-or-mds-100544732","NCT06372717","A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS","A Phase 1 Study to Assess the Safety and Antitumor Activity of APL-4098 Alone and in Combination With Azacitidine and in Combination With Azacitidine Plus Venetoclax in Adults With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome\u002FAML (MDS\u002FAML) or Myelodysplastic Syndrome With Excess Blasts (MDS-EB)","Inclusion Criteria:\n\n* 18 years or older\n* Confirmed diagnosis of relapsed refractory acute myeloid leukemia (R\u002FR AML), myelodysplastic syndrome (MDS)\u002F AML, or MDS-excess blasts (MDS-EB) with the following characteristics: - R\u002FR AML (primary or secondary, including treatment-related), participant is intolerant to, or considered ineligible for available therapies known to provide clinical benefit.\n* WBC count ≤ 25,000\u002Fmicroliter\n* ECOG Performance Status of ≤ 2\n* Weight ≥ 40kg\n* Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse\n* Male participants must be willing to use specific contraception and not plan to impregnant a female partner or donate sperm while on study\n* Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial\n\nExclusion Criteria:\n\n* Certain prior therapies such as: received an allogeneic stem cell transplant within 6 months of screening, received an autologous stem cell transplant within 3 months of screening, received any anti-cancer treatments within 2 weeks of Cycle 1 Day 1, prior radiation therapy within 4 weeks of screening\n* Certain medical conditions such as: other malignancies, myocardial infarction within 6 months of screening, symptomatic congestive heart failure, uncontrolled active infection, history of arterial thrombosis within 6 months of screening\n* Diagnostic assessments: Left ventricular ejection fraction \\\u003C 45%, Fridericia's corrected QT interval \\> 470msec, Aspartate aminotransferase and\u002For alanine aminotransferase \\> 3 x upper limit of normal (ULN), total bilirubin \\> 1.5 x ULN, calculated or measured creatinine clearance \\\u003C 45 mL\u002Fminute (multiply by 0.85 if female)\n* Infectious disease: HIV positive, active hepatitis B and\u002For C",{"count":142,"type":22},100,[60],"This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)\u002FAML and MDS-excess blasts (EB).",[29,146,147,66,148],"Myelodysplastic Syndrome Acute Myeloid Leukemia","Myelodysplastic Syndrome With Excess Blasts","Acute Myeloid Leukemia (AML)","2026-05-29",{"date":151,"type":40},"2026-06-01",{"date":153,"type":40},"2024-06-04",{"date":155,"type":22},"2027-05-01",{"name":157,"class":158},"Apollo Therapeutics Ltd","INDUSTRY",9,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":174,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":48},"100417497","phase-1-study-of-c6-ceramide-nanoliposome-cnl-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100417497","NCT04716452","Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Phase I Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia (RR-AML)","KNAN2001","Inclusion Criteria:\n\n1. Signed informed consent is obtained prior to conducting any study-specific screening procedures.\n2. Willing and able to understand the nature of this study and to comply with the study and follow-up procedures.\n3. Age and Disease: ≥ 18 years of age with refractory or relapsed AML\n\n   Refractory AML: Patients who fail to achieve a complete remission (CR) or a complete remission with incomplete count recovery (CRi) after one or more ines of AML directed therapy.\n\n   Relapsed AML: Patients who achieved a complete remission (CR) or a complete remission with incomplete count recovery (CRi) with one or more prior lines of AML directed therapy but then developed a relapse of AML.\n\n   Note: Patients are eligible even if they have not received intensive induction chemotherapy but have been treated with other AML directed therapy like hypomethylating agents (azacitidine, decitabine).\n4. Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2.\n5. ECOG performance status must be ≤2\n6. Peripheral white blood cell (WBC) count \\\u003C30,000\u002FµL. For cyto-reduction, the following are allowed to reduce WBC count to \\\u003C 30,000\u002FµL:\n\n   * hydroxyurea is allowed during screening and through the end of Cycle,\n   * cytarabine is allowed during screening but not after registration and should be limited 1 g\u002Fm2 or less from time of consent to registration.\n7. Adequate organ function as evidenced by the following laboratory findings:\n\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) or \\\u003C 3 x ULN for patients with Gilbert-Meulengracht Syndrome\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN if not attributed to leukemia, or ≤ 5 x ULN if attributed to leukemia\n   * Creatinine clearance \\> 60 mL\u002Fmin.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are ineligible for study entry:\n\n1. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months before registration, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n2. Patients may not be receiving any other concurrent investigational agents during study treatment and not for at least within one week prior to starting study treatment.\n3. Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded.\n4. History of any other malignancies within the preceding 12 months before registration with the exception of in-situ cancer, non-muscle invasive bladder cancer, non-metastatic prostate cancer, basal or squamous cell skin cancer.\n5. Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the Investigator's opinion, could compromise the patient's safety or put the study outcomes at risk.\n6. Evidence of isolated extramedullary disease.\n7. Acute Promyelocytic Leukemia.\n8. AML with active central nervous system (CNS) involvement (as determined by study investigator).\n9. Severe infection requiring treatment that would interfere with study drug(s) or study participation in the opinion of the treating investigator.\n10. Past Hematopoietic stem cell transplant (HSCT) with graft vs host disease, immunosuppression other than low dose prednisone (10 mg) (or equivalent does of another immunosuppressant) within the 4 weeks before registration.\n11. All adverse reactions from prior therapy must have recovered to Grade ≤ 1 or acceptable baseline per treating investigator.",{"count":58,"type":22},[60],"The study objective is to evaluate patient safety for patients with refractory and relapsed AML being treated with Ceramide NanoLiposome (CNL) .",[66,172,173],"Acute Myeloid Leukemia, Refractory","Refractory\u002FRelapse Acute Myeloid Leukemia",[65,122,123,175,176,177,178,179,180,181,182],"Ceramide","AML","NanoLiposome","Relapsed\u002FRefratory Acute Myleoid Leukemia","NanoLiposomes","Safety","CNL","Ceraxa","2026-03-26",{"date":185,"type":40},"2026-03-31",{"date":187,"type":40},"2025-10-01",{"date":189,"type":22},"2026-11-30",{"name":191,"class":158},"Keystone Nano, Inc",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":48},"100463646","phase-1-venetoclax-to-augment-epigenetic-modification-and-chemotherapy-100463646","NCT05317403","Venetoclax to Augment Epigenetic Modification and Chemotherapy","A Phase I Study of Venetoclax to Augment Epigenetic Modification and Chemotherapy in Pediatric and Young Adult Patients With Relapsed and Refractory Acute Myeloid Leukemia","Inclusion Criteria\n\n* Diagnosis\n\n  1. Patients with AML must have measurable disease (≥M1 marrow) in the bone marrow.\n\n     * 1st or greater relapse, OR\n     * Failed to go into remission after 1st or greater relapse, OR\n     * Failed to go into remission from original diagnosis after 2 or more induction attempts\n  2. Patients may have CNS or other sites of extramedullary disease. No cranial irradiation is allowed during the protocol therapy.\n  3. Patients with treatment related AML (tAML) are eligible. A relapse of tAML is not necessary to enroll on this study thus newly diagnosed tAML are eligible.\n  4. Patients with immunophenotypic AML evolving as lineage switch from ALL or acute leukemia NOS, may be eligible if they have relapsed\u002Frefractory disease\n  5. Patients with Down syndrome are eligible\n* Performance Level- Karnofsky \\> 50% for patients \\> 16 years of age and Lansky \\> 50% for patients ≤ 16 years of age. (See Appendix II for Performance Scales)\n* Prior Therapy- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n\n  1. Myelosuppressive chemotherapy\n  2. Cytoreduction with hydroxyurea Hydroxyurea can be initiated and continued for up to 24 hours prior to the start of Venetoclax. It is recommended to use hydroxyurea in patients with significant leukocytosis (WBC \\> 50,000\u002FL) to control blast count before initiation of systemic protocol therapy.\n  3. Patients who relapsed while they are receiving cytotoxic therapy At least 7 days must have elapsed since the completion of the cytotoxic therapy, except Intrathecal chemotherapy.\n  4. Hematopoietic stem cell transplant: Patients who have experienced relapse after a HSCT are eligible, provided they have no evidence of acute or chronic Graft-versus-Host Disease (GVHD), and are at least 90 days post-transplant at the time of enrollment, no longer receiving GVHD therapy.\n  5. Hematopoietic growth factors: It must have been at least 7 days since the completion of therapy with GCSF or other growth factors at the time of enrollment. It must have been at least 14 days since the completion of therapy with pegfilgrastim (Neulasta®).\n  6. Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair. This includes flotetuzumab.\n  7. Monoclonal antibodies: At least 3 half-lives of the antibody must have elapsed after the last dose of monoclonal antibody. (i.e. Gemtuzumab = 36 days)\n  8. Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines or CAR-T cells.\n  9. XRT: Craniospinal XRT is prohibited during protocol therapy. No waiting period is necessary for radiation given to non-CNS chloromas; ≥ 90 days must have elapsed if prior TBI or craniospinal XRT.\n  10. Infection Prevention: Patients must be able to tolerate and receive anti-fungal prophylaxis with echinocandins or amphotericin therapy for the duration of their treatment course and neutrophil recovery (post-nadir ANC is \\> 750\u002FμL).\n  11. Inhibitors and Inducers ofCYP3A4\n\n      * Patients taking strong CYP3A4 inhibitors should have their venetoclax dose reduced by 75%\n      * Patients taking moderate CYP3A4 inhibitors should have their venetoclax dose reduced by 50%\n      * Inhibitors of P-glycoprotein (P-gp): Patients taking p-glycoprotein inhibitors should have their venetoclax doses reduced by 50%.\n* Renal and hepatic function- Patients must have adequate renal and hepatic functions as indicated by the following laboratory values:\n\n  1. Adequate renal function defined as: Patient must have a calculated creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73m2 OR a normal serum creatinine\n  2. Adequate Liver Function Defined as: Direct bilirubin \\\u003C 1.5 x upper limit of normal (ULN) for age or normal, AND alanine transaminase (ALT) \\\u003C 5 x ULN for age. The hepatic requirements are waived for patients with known or suspected liver involvement by leukemia. This must be reviewed by and approved by the study chair or vice chair.\n* Adequate Cardiac Function Defined as: Shortening fraction of ≥ 27% OR ejection fraction of ≥ 50%.\n* Reproductive Function\n\n  1. Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment.\n  2. Female patients with infants must agree not to breastfeed their infants while on this study.\n  3. Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after study treatment.\n* Informed Consent- Patients and\u002For their parents or legal guardians must be capable of understanding the investigational nature, potential risks, and benefits of the study. All patients and\u002For their parents or legal guardians must sign a written informed consent. Age-appropriate assent will be obtained per institutional guidelines. To allow non-English speaking patients to participate in this study, bilingual health services will be provided in the appropriate language when feasible.\n* Protocol Approval- All institutional, FDA, and OHRP requirements for human studies must be met.\n\nExclusion Criteria\n\n•.Patients will be excluded if they have a known allergy to any of the drugs used in the study.\n\n* Patients will be excluded if they have a systemic fungal, bacterial, viral, or other infection that is exhibiting ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient needs to be off pressors and have negative blood cultures for 48 hours.\n* Patients will be excluded if they have had any positive fungal culture within 30 days prior to enrollment or evidence of disseminated fungal disease.\n* Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.\n* Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder, or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results.\n* Patients with DNA fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded.","25 Years",{"count":201,"type":22},40,[60],"The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients.",[66,29],"2026-01-09",{"date":207,"type":40},"2026-01-12",{"date":209,"type":40},"2023-03-31",{"date":211,"type":22},"2027-01",{"name":213,"class":47},"Medical College of Wisconsin",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":48},"100447339","phase-1-plat-08-a-study-of-sc-daric33-car-t-cells-in-pediatric-and-young-adults-with-relapsed-or-refractory-cd33-aml-100447339","NCT05105152","PLAT-08: A Study Of SC-DARIC33 CAR T Cells In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML","Pediatric And Young Adult Leukemia Adoptive Therapy (PLAT)-08: A Phase 1 Study Of SC-DARIC33 In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML","Inclusion Criteria:\n\n1. Subject age ≤ 30 years. The first three enrolled subjects must be ≥ 18 years of age.\n2. AML that expresses CD33 by flow cytometry and meets one of the below definitions:\n\n   1. For subjects who have previously received an allogeneic HCT, any evidence of AML re-emergence post HCT detectable by flow cytometry\n   2. First relapse of AML ≤ 6 months of initial diagnosis\n   3. First relapse of AML \\> 6 months after initial diagnosis, with MRD of \\>0.1% by flow cytometry (MPF) after at least one re-induction (single cycle) attempt\n   4. Second or greater relapse AML\n   5. Refractory AML, defined as \\>1% leukemic cells determined by flow cytometry after 2 cycles of induction chemotherapy\n3. Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product.\n4. Life expectancy ≥ 8 weeks\n5. Has an appropriate stem cell donor source identified\n6. Lansky performance status score of ≥ 50 for subjects \\\u003C16 years of age or Karnofsky score ≥ 50 for subjects ≥ 16 years. Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status\n7. If a subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of DARIC T cells, the subject must discontinue all anticancer agents and radiotherapy and, in the opinion of the investigator, have fully recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy:\n\n   a. Chemotherapy and biologic agents: All chemotherapy and biologic therapy not specifically mentioned below must be discontinued ≥ 7 days prior to enrollment, with the exception of intrathecal chemotherapy for which there is not a required washout period b. Must be ≥ 30 days from last gemtuzumab ozogamicin dose. c. Steroid use: All corticosteroid therapy (unless physiologic replacement dosing) must be discontinued ≥ 7 days prior to enrollment d. Tyrosine Kinase Inhibitor (TKI) use: All TKIs must be discontinued ≥ 3 days prior to enrollment e. Hydroxyurea: must be discontinued ≥ 1 day prior to enrollment. f. Gene Modified cellular therapy: i. must be at least 30 days from most recent gene modified cell therapy infusion and document no evidence of modified cells in the peripheral blood OR ii. must be at least 60 days from most recent gene modified cell therapy\n8. Adequate organ function as indicated by:\n\n   1. Renal: Serum creatinine ≤ 1.5 X the upper limit of normal (ULN)\n   2. Hepatic: Total bilirubin ≤ 3 times ULN for age OR conjugated bilirubin ≤ 2 mg\u002FdL AND ALT (SGPT) ≤ 5 times ULN\n   3. Cardiac: Shortening fraction ≥ 28% OR ejection fraction ≥ 50% as measured by echocardiogram\n   4. Respiratory: Oxygen saturation ≥ 92% on room air without supplemental oxygen or mechanical ventilation\n9. Laboratory values meet the following criteria:\n\n   a. Subjects requiring apheresis: Absolute Lymphocyte Count (ALC) ≥ 100 cells\u002FuL b. Virology Testing negative within 3 months prior to enrollment, to include: i. HIV antigen \\& antibody ii. Hepatitis B surface antigen iii. Hepatitis C antibody OR if positive, Hepatitis C PCR is negative\n10. If subject is of childbearing or child-fathering potential, must agree to use highly effective contraception from the time of initial consent through 12 months following the infusion of investigational product on this trial.\n11. Subject and\u002For legally authorized representative has signed the Informed Consent Form for this study\n\nExclusion Criteria:\n\n1. Active malignancy other than acute myeloid leukemia\n2. History of symptomatic non-AML CNS disease or ongoing symptomatic CNS disease requiring medical intervention, including paresis, aphasia, cerebrovascular ischemia\u002Fhemorrhage, severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder (subjects with non-febrile seizure disorder controlled on anti-epileptic medication and without seizure activity within 1 month are eligible).\n3. CNS AML involvement that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and DARIC T cell infusion\n4. If history of allogeneic stem cell transplant: active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment\n5. Presence of active severe infection, defined as:\n\n   i. positive blood culture within 48 hours of enrollment, OR ii. fever above 38.2° C, AND clinical signs of infection within 48 hours of enrollment\n6. Primary immunodeficiency syndrome\n7. Subject has received prior virotherapy\n8. Pregnant or breastfeeding\n9. Subject and\u002For legally authorized representative unwilling to provide consent\u002Fassent for participation in the 15-year follow-up period, required if DARIC T cell therapy is administered\n10. Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol\n11. Considered by the investigator to be unable to tolerate a lymphodepleting regimen\n12. Subject has a contraindication to receiving rapamycin","30 Years",{"count":5,"type":22},[60],"A phase 1, open-label, non-randomized study enrolling pediatric and young adult patients with relapsed or refractory CD33+ leukemia with and without prior history of allogeneic hematopoietic cell transplantation, to examine the safety and feasibility of administering an autologous T cell product that has been genetically modified to express a Dimerizing Agent Regulated Immunoreceptor Complex (DARIC).",[65,29,66],"2025-12-16",{"date":228,"type":40},"2025-12-23",{"date":230,"type":40},"2021-11-29",{"date":232,"type":22},"2041-01-31",{"name":234,"class":47},"Seattle Children's Hospital",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":23,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":257},"100568402","phase-1-clinical-study-of-ard103-car-t-therapy-for-patients-with-rr-aml-or-mds-100568402","NCT06680752","Clinical Study of ARD103 CAR-T Therapy for Patients With R\u002FR AML or MDS","A Phase 1\u002F2, Open-label, Multicenter Trial to Assess the Safety and Efficacy of ARD103 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate hematologic status:\n\n  * Absolute lymphocyte count (ALC) \\> 100\u002Fmm3\n* Adequate renal, hepatic, cardiac and pulmonary function:\n\n  * ALT and AST \\\u003C 3.0 × the ULN\n  * Creatinine clearance ≥ 45.0 mL\u002Fmin as estimated by Cockcroft-Gault and independent dialysis\n  * Total bilirubin ≤ 2.0 mg\u002FdL\n* Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test\n* Contraception: males and females of childbearing potential must agree to use an effective method of contraception\n* Participant is capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Participants with acute promyelocytic leukemia\n* Presence of active and clinically relevant central nervous system (CNS) disorder\n* Autoimmune disease requiring immunosuppressive treatment\n* Participants with known hepatic bridging cirrhosis\n* Currently active infection with hepatitis B or C\n* Previous treatment with investigational gene or cell therapy (including CAR therapy)\n* Any active acute GvHD or systemic treatment of more than 10 mg prednisone daily (or equivalent)\n* Previous chemotherapy including biologic\u002Ftargeted therapy or immunological agents directed to the pathology within 14 days prior to screening and all along the study duration",{"count":243,"type":22},49,[60,25],"This is a phase I\u002F2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.",[66,29,247],"MDS (Myelodysplastic Syndrome)","2025-12-04",{"date":250,"type":40},"2025-12-10",{"date":252,"type":40},"2025-05-20",{"date":254,"type":22},"2028-12",{"name":256,"class":158},"ARCE Therapeutics, Inc.",3,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100455516","phase-1-ab8939-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100455516","NCT05211570","AB8939 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase 1\u002F2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","DOSE ESCALATION STUDY\n\nKey Inclusion Criteria:\n\n* Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.\n* Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system.\n* ECOG performance status ≤ 1\n* Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures\n* Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies\n\nKey Exclusion Criteria:\n\n* Patients eligible to a standard of care\n* Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion\n* Patients diagnosed with acute promyelocytic leukemia (M3)\n* Patients with clinically active CNS leukemia\n* Patients with HSCT within 100 days prior to the first administration of AB8939\n* Women who are lactating\u002Fbreastfeeding or who plan to breastfeed while on study\n* Women with a positive pregnancy test\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply\n\nEXPANSION COHORT STUDY\n\nKey Inclusion Criteria:\n\n* Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.\n* ECOG performance status ≤ 2\n* Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures\n* Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies\n\nKey Exclusion Criteria:\n\n* Patients eligible to a standard of care\n* Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion\n* Patients diagnosed with acute promyelocytic leukemia (M3)\n* Patients with clinically active CNS leukemia\n* Patients with HSCT within 100 days prior to the first administration of AB8939\n* Women who are lactating\u002Fbreastfeeding or who plan to breastfeed while on study\n* Women with a positive pregnancy test\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply",{"count":266,"type":22},78,[60,25],"The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.",[29,66,146],"2025-09-29",{"date":272,"type":40},"2025-10-02",{"date":274,"type":40},"2022-06-01",{"date":276,"type":22},"2026-12",{"name":278,"class":158},"AB Science",10,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":295,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":305},"100537747","phase-1-an-adaptive-open-label-multicentre-phase-12-trial-to-determine-the-recommended-phase-2-dose-of-cctx-001-and-to-assess-safety-tolerability-and-clinical-activity-in-patients-with-relapsedrefractory-acute-myeloid-leukaemia-100537747","NCT06281847","An Adaptive Open-label Multicentre Phase 1\u002F2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed\u002FRefractory Acute Myeloid Leukaemia","RESOLVE AML001","Inclusion Criteria:\n\n1. Patients with active (\\> 5 % blasts in bone marrow) r\u002Fr AML (WHO 2022) who have exhausted their therapeutic alternatives or have contraindications to these alternatives as judged by the treating physician defined as either:\n\n   a. Primary refractory: i. Patients who failed after two cycles of intensive induction including high-dose and\u002For standard dose cytarabine (including liposomal formulation), +\u002F- anthracycline, +\u002F- antimetabolite, +\u002F- targeted therapy or ii. Older patients or patients unfit to receive intensive induction courses who failed after two cycles of venetoclax + azacitidine or 4 cycles of azacitidine b. Relapsing: i. Patients with early relapse after CR to first line therapy (within ≤ 6 months after CR1) or ii. Patients with relapse after later lines of therapy (Relapse after CR≥2) c. Patients relapsing after allogeneic hematopoietic stem cell transplant: i. Patients must be at least 3 months from hematopoietic stem cell transplant (HSCT) at the time of consent, and ii. Off immunosuppression for at least 1 month at the time of consent, and iii. Have no active graft versus host disease (GvHD)\n2. Have a circulating blast count of less than 20,000\u002Fmm3 (control with hydroxyurea is allowed)\n3. Absolute Lymphocyte count of \\>200\u002Fmm3\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n5. Life expectancy of more than 3 months\n6. Patient is ≥ 18 years of age at the time of informed consent\n7. Read, understood, and signed the informed consent form (ICF) prior to any study procedures\n8. Patient is willing and able to adhere to the study visit schedule and other protocol requirements\n9. Eligible for leukapheresis\n10. Treatment-related toxicities of previous therapies have completely resolved\n11. Adequate organ function as confirmed by clinical laboratory values, defined as:\n\n    1. Adequate bone marrow function to receive LDC as assessed by the Investigator\n    2. Serum creatinine \\[\\\u003C 1.5 x the upper limit of normal (ULN) or creatinine clearance (CrCl) \\> 45 mL\u002Fmin\\] (estimated by Cockcroft Gault or Modification of Diet in Renal Disease (MDRD); see Appendix 14.3 for calculation)\n    3. Alanine aminotransferase \\[≤ 3 x ULN and total bilirubin \\\u003C 1.5 mg\u002FdL (or \\\u003C 3.0 mg\u002FdL\\] for patients with Gilbert's syndrome or leukemic infiltration of the liver)\\]\n    4. Adequate pulmonary function, defined as \\[≤ Grade 1 dyspnoea according to CTCAE and oxygen saturation (SaO2) ≥ 92% on room air and forced expiratory volume in the first second ≥ 50%\\]\n    5. Ejection fraction \\> 40% assessed by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed within 1 month before CCTx-001 infusion\n12. Women of childbearing potential\\* (WOCBP) must have a negative serum pregnancy test performed at screening and within 7 days before enrolment\n13. WOCBP or males whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception during the study and for 12 months after the last dose of LDC. For the definition and list of highly effective methods of contraception.\n\nExclusion Criteria:\n\n1. Patients with an acute promyelocytic leukaemia: t(15;17)(q22;q12); (promyelocytic leukaemia\u002Fretinoic acid receptor alpha) and variants\n2. Patients with active central nervous system (CNS) leukaemia involvement. If the patient has prior history of CNS leukaemia, they must have a negative cerebrospinal fluid (CSF) assessment and magnetic resonance imaging (MRI) or computed tomography (if MRI is not feasible) of the brain demonstrating no evidence of CNS disease\n3. Patients with isolated extramedullary AML disease\n4. Patients who received previous treatment targeting IL-1RAP or previous gene therapy\n5. Patients who underwent allo-HSCT within 90 days prior to leukapheresis\n6. Patients who received donor lymphocyte infusion within 60 days prior to leukapheresis\n7. Patients with active GvHD\n8. Patients with history of another primary malignancy other than disease under study unless the patient has been free of the disease for ≥ 2 years, except for the following non-invasive malignancies:\n\n   1. Basal cell carcinoma of the skin\n   2. Squamous cell carcinoma of the skin\n   3. Carcinoma in situ of the cervix\n   4. Carcinoma in situ of the breast\n   5. Incidental histologic finding of prostate cancer (T1a or T1b) or prostate cancer that is curative\n   6. Other completely resected stage 1 solid tumour with low risk for recurrence\n9. Presence of systemic fungal, bacterial, viral, or other infection (including tuberculosis) that is uncontrolled despite appropriate antibiotics or other treatments\n10. Active or prior history of hepatitis B or hepatitis C infection\n11. History of or active human immunodeficiency virus (HIV) infection\n12. Active macrophage activation syndrome (MAS) as evidenced by laboratory abnormalities (e.g.: elevated ferritin, elevated triglycerides, haemophagocytosis on the bone marrow sample) and\u002For clinical signs\n13. History or presence of an active and clinically relevant CNS disorder such as epilepsy, generalised seizure disorder, paresis, aphasia, stroke, cerebral oedema, severe brain injury, dementia, multiple sclerosis, Parkinson's disease, cerebellar disease, organic brain syndrome, or posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement\n14. Patients with active autoimmune disorders or active neurological or inflammatory disorders (e.g., Guillain-Barre Syndrome, Amyotrophic Lateral Sclerosis) requiring immunosuppressive therapy or corticosteroid therapy (defined as \\>20 mg\u002Fday prednisone or equivalent). Physiologic replacement, topical, and inhaled steroids are permitted.\n15. Use of the following (see Section 8.3 for full details):\n\n    1. Therapeutic doses of corticosteroids (defined as \\> 20 mg\u002Fday prednisone or equivalent) within 7 days prior to leukapheresis or 72 hours prior to CCTx-001 infusion. Physiologic replacement, topical, and inhaled steroids are permitted.\n    2. Immunosuppressive therapies within 4 weeks prior to signing the ICF (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-tumour necrosis factor \\[TNF\\], anti-IL-6, or anti-IL-6 receptor \\[IL-6R\\])\n    3. Cytotoxic chemotherapeutic agents (including intrathecal) within 14 days prior to leukapheresis.\n    4. Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis\n    5. Experimental agents within 4 weeks prior to signing the ICF unless no response or progressive disease (PD) is documented on the experimental therapy and at least 3 half-lives have elapsed prior to signing the ICF.\n    6. Therapeutic anticoagulation\n16. History of any one of the following cardiovascular conditions within the past 6 months prior to signing the ICF:\n\n    1. Class III or IV heart failure as defined by the New York Heart Association\n    2. Cardiac angioplasty or stenting\n    3. Myocardial infarction\n    4. Unstable angina\n    5. Other clinically significant cardiac disease\n17. Known hypersensitivity to DMSO or other excipients\n18. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or unwillingness or inability to follow the procedures required in the protocol.\n19. Abnormal findings and\u002For clinically significant Grade ≥3 non-haematological toxicity and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient's safety.\n20. Presence of any condition that confounds the ability to interpret data from the study based on Investigator´s judgement.\n21. Any planned medical\u002Fsurgical treatment that might interfere with the ability to comply with the study requirements.\n22. Pregnant or nursing women. NOTE: WOCBP must have a negative serum pregnancy test performed within 48 hours of starting LDC",{"count":288,"type":22},143,[60,25],"The purpose of this adaptive Phase 1\u002F2 study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antileukemic activity of CCTx-001 in adult patients with r\u002Fr Acute Myeloid Leukemia (AML). CCTx-001 targets IL-1RAP, which is specifically expressed in leukemic cells. In preclinical studies, IL-1RAP-targeted Chimeric antigen receptors (CARs) have demonstrated encouraging activity in both in vitro and in vivo experiments in AML models. Based on these promising preclinical results, it is expected that CCTx-001 could potentially alter the natural course of r\u002Fr AML and provide a potential novel treatment option.",[66,29],[65,122,123,293,180,294],"Open-label","Tolerability","NOT_YET_RECRUITING","2025-09-12",{"date":298,"type":40},"2025-09-18",{"date":300,"type":22},"2025-12",{"date":302,"type":22},"2041-08",{"name":304,"class":158},"Advesya SAS",6,{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":327},"100512182","phase-1-phase-1-study-of-allo-revcar01-t-cd123-in-patients-with-selected-cd123-positive-hematologic-malignancies-100512182","NCT05949125","Phase 1 Study of Allo-RevCAR01-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies","Multicenter, Open-label, Phase 1 Study of Allo-RevCAR01-T-CD123 Consisting of Genetically Modified T Cells Carrying Reverse Chimeric Antigen Receptors (Allo RevCAR01 T) in Combination With CD123 Target Module (R-TM123) for the Treatment of Patients With Selected Hematologic Malignancies Positive for CD123","Inclusion Criteria:\n\n1\\. Male or female participants, age ≥18 years. 2. HLA type of participant must match at HLA B and C loci 3.\n\n1. For Phase 1a escalation part of the trial Participants with CD123+ AML (defined as ≥20% of leukemic cells expressing CD123 at any point in the course of disease)\n\n   (1) for whom all standard or life-extending therapies have failed and for whom no potentially curative therapies are available or who are intolerant to such therapies.\n2. For Phase 1b expansion part of the trial (Phase 1b) Participants with CD123+ AML (defined as ≥20% of leukemic cells expressing CD123 at any point in the course of disease)\n\n   1. up to 3rd relapse for whom all standard or life-extending therapies have failed and for whom no potentially curative therapies are available or who are intolerant to such therapies\n   2. having up to 30% blasts in a bone marrow assessment at either screening or prescreening, or having between 30% and 40% blasts for two consecutive bone marrow assessments with a minimum of one month and no more than two months apart,\n   3. without hyperproliferative disease requiring cytoreductive treatment,\n   4. exceptions to BM blast criterion are only possible in minor deviations in timing and\u002For blast count in clinically stable patients, and only with written sponsor approval. Exceptions to minimum CD123 expression are not allowed.\n3. For Phase 1a escalation and Phase 1b expansion part of the trial\n\nParticipants with MRD+ AML are potentially eligible but must meet the following criteria:\n\n1. MRD positivity must be based on assays and markers supported by consensus guidelines \\[Heuser2021\\] and in the judgment of the investigator must confer negative prognostic risk highly likely to result in relapse.\n2. must have received or be ineligible for allogeneic stem cell transplant.\n3. must be approved by the Sponsor for inclusion in the study. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Life expectancy of at least 3 months in the judgment of the investigator. 6. Adequate renal and hepatic laboratory assessments: 7. Adequate cardiac function 8. Long-term central venous access existing (e.g., port-system) or willing to have such a device inserted.\n\n9\\. Able to give written informed consent. 10. Weight ≥45 kg. 11. Negative pregnancy; routinely using a highly effective method of birth control\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia (t15;17).\n2. AML with only extramedullary manifestations (e.g., chloroma, primary myeloid sarcoma)\n3. Acute manifestationof AML in the central nervous system.\n4. Bone marrow failure syndromes\n5. Cardiac disease: heart failure (New York Heart Association III or IV); unstable coronary artery disease, myocardial infarction, or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy within the last 6 months prior to study entry.\n6. Active pulmonary disease with clinically relevant hypoxia\n7. Parkinson's disease or epilepsy with clinical symptoms in the previous 12 months .\n8. Stroke, seizure, or intracranial hemorrhage in the past 12 months.\n9. History or presence of disseminated intravascular coagulation (DIC), deep vein thrombosis or thromboembolism within 3 months prior to start of treatment.\n10. Active infectious disease considered by investigator to be incompatible with protocol or being contraindications for lymphodepletion therapy\n11. Presence of hemorrhagic cystitis\n12. Other toxicity from prior anticancer treatment has not resolved to Grade ≤1 or baseline.\n13. Allogeneic stem cell transplantation within last 2 months or GvHD requiring systemic immunosuppressive therapy.\n14. Vaccination with live viruses \\\u003C 2 weeks prior to lymphodepletion therapy.\n15. Major surgery within 28 days prior to start of R-TM123 infusion.\n16. Prior malignancy in the past 3 years or any malignancy requiring ongoing active therapy other than adjuvant endocrine therapy. Participants with resected or ablated tumors, such as basal cell carcinoma of skin, carcinoma-in-situ of the cervix, or other tumors considered cured may be considered for the study with Sponsor approval.\n17. Treatment with any investigational drug substance or experimental therapy within 4 weeks or 5 half-lives (whichever is shorter) of the substance prior to lymphodepletion.\n18. Treatment with anti-leukemic therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to lymphodepletion.\n19. Prior treatment with gene modified cell products.\n20. Use of checkpoint inhibitors within 5 half-lives of the specific drug.\n21. Autoimmune diseases requiring systemic steroids or other systemic immunosuppressants.\n22. Pregnant or breastfeeding women.\n23. Psychologic disorders with treatment modifications required within the last 3 months, drug and\u002For significant active alcohol abuse as per investigator's medical judgement. Depression or anxiety due to presence of the underlying malignancy may be exempted with Sponsor approval.\n24. History of human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV) or active\u002Fchronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).\n25. Presence of autoantibodies against lupus La protein (La)\u002F Sjögren syndrome type B antigen (SS-B) or presence or history of autoimmune diseases associated with such antibodies\n26. Known hypersensitivity to cellular component (Allo-RevCAR01-T) and\u002For TM (R-TM123) excipients or to compounds of the lymphodepletion therapy, tocilizumab, or corticosteroids.\n27. Evidence that the participant is not likely or able to follow the study protocol (e.g., lacking compliance) in the judgment of the investigator.\n28. Participant unable to understand the informed consent and possible consequences of the participation in the clinical trial in the judgement of the investigator.",{"count":314,"type":22},80,[60],"The Allo-RevCAR01-T-CD123 drug is a combination of a cellular component (Allo-RevCAR01-T) with a recombinant antibody derivative (R-TM123), which together form the active drug. The cellular component Allo-RevCAR01-T consists of an allogeneic human T-cell genetically multi-edited and expressing a reversed, universal chimeric antigen receptor (RevCAR) presenting an extracellular peptide epitope (RevCAR epitope). R-TM123 functions as a bridging module between Allo-RevCAR01-T and a CD123-expressing target cancer cell by selectively binding the RevCAR epitope and CD123.",[66,29],"2025-05-09",{"date":320,"type":40},"2025-05-14",{"date":322,"type":40},"2024-01-03",{"date":324,"type":22},"2028-01",{"name":326,"class":158},"AvenCell Europe GmbH",11,{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":159},"100538984","phase-1-study-of-rem-422-in-patients-with-aml-or-higher-risk-mds-100538984","NCT06297941","Study of REM-422 in Patients With AML or Higher Risk MDS","A Phase 1, Multicenter, Open-Label Study of REM-422, an MYB mRNA Degrader, in Patients With Relapsed\u002FRefractory AML or Higher-Risk MDS","Inclusion Criteria:\n\n1. Be able to provide informed consent.\n2. Be 18 or older at the time of informed consent.\n3. Disease criteria:\n\n   Histologically confirmed diagnosis of either:\n   1. R\u002FR AML, defined as relapse after transplantation, second or later relapse, refractory to initial induction or reinduction treatment or to initial treatment with hypomethylating (HMA)-based combinations, relapse after initial treatment, or otherwise considered relapsed or refractory in the opinion of the Investigator.\n   2. High-risk and very-high-risk (VHR) MDS (higher-risk) per the International Prognostic Scoring System-Revised (IPSS-R) and\u002For International Prognostic Scoring System-Molecular (IPSS-M).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Has agreed to undergo serial blood and bone marrow sampling.\n6. Participants must have completed systemic non-investigational therapy at least 14 days prior to initiating REM-422. Hydroxyurea is permissible for controlling peripheral leukemic blasts prior to enrollment and for up to 28 days following initiation of REM-422.\n7. Toxicities from prior therapy must be either stable or recovered to ≤ Grade 1.\n8. Participants must be able to swallow and retain oral medications.\n9. Oxygen saturation \\> 92% on room air or up to 2 L\u002Fmin supplemental oxygen by nasal cannula with ≤ Grade 1 dyspnea.\n10. People of childbearing potential (POCBP) must have a negative serum beta-human chorionic gonadotropin test result.\n11. POCBP must agree to use acceptable, effective methods of contraception and not donate ova from screening until 6 months after discontinuation of REM-422. Women who have undergone surgical or ablative sterilization or who have been postmenopausal for ≥ 2 years are not considered to be of childbearing potential.\n12. Men must agree to use acceptable, effective methods of contraception and must agree not to donate sperm from the start of receiving REM-422 until 6 months after discontinuation of REM-422.\n13. Adequate organ function and laboratory parameters\n\nExclusion Criteria:\n\n1. Active central nervous system (CNS) leukemia or a confirmed diagnosis of CNS leukemia.\n2. Has undergone hematopoietic stem cell transplantation (HSCT) within 60 days of the first dose of REM-422 or is receiving immunosuppressive therapy post HSCT at the time of screening, or has GVHD requiring systemic treatment (topical steroids for ongoing skin GVHD is permitted).\n3. Has immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and\u002For disseminated intravascular coagulation.\n4. Known hypersensitivity or contraindication to any component of REM-422 or to drugs chemically related to REM-422 or its excipients.\n5. Clinically significant active infection. Note: Patients with simple urinary tract infection or uncomplicated bacterial pharyngitis responding to active treatment are permitted. Note: Patients receiving intravenous (IV) antibiotics ≤ 7 days prior to enrollment are excluded (prophylactic antibiotics, antivirals, or antifungals are permitted).\n6. Evidence of active HIV infection.\n7. Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n8. Primary immunodeficiency.\n9. Current or expected need for daily systemic corticosteroid therapy ≥ 10 mg of prednisone equivalent.\n\n   Note: Patients who are receiving topical or inhaled corticosteroids with minimal systemic absorption are eligible for enrollment and may continue with minimal corticosteroid use as long as they are on a stable dose.\n10. Live vaccine ≤ 6 weeks prior to the start of REM-422.\n11. Use of strong CYP3A inhibitors (except azole antifungals) or CYP3A inducers\n12. Drugs that reduce gastric acidity, such as H2-receptor antagonists (eg, ranitidine, famotidine) and proton pump inhibitors (eg, omeprazole, esomeprazole) within 7 days prior to the initiation of REM-422 administration or during the study.\n13. Currently pregnant, have intentions to become pregnant during the study duration, or are currently lactating.\n14. Has dysphagia, short-gut syndrome, gastroparesis, or any other condition that limits the ingestion or gastrointestinal absorption of orally administered drugs.\n15. Current use of prohibited medication ≤ 1 week before starting REM-422.\n16. Clinically significant cardiovascular disease:\n17. Has undergone major surgery (opening a mesenchymal barrier such as the pleural cavity, peritoneum, or meninges or surgical procedures requiring general anesthesia) \\\u003C 4 weeks prior to enrollment.\n18. History of organ transplant that requires use of immunosuppressive agents.\n19. History or current autoimmune disease requiring systemic treatment (eg, Crohn's disease, ulcerative colitis, rheumatoid arthritis, systemic lupus).\n20. Radiation therapy ≤ 7 days prior to the start of REM-422.\n21. Concurrent or previous other malignancy ≤ 2 years of enrollment, except curatively treated malignancies including basal or squamous cell skin cancer, breast cancer, prostate intraepithelial neoplasm, and carcinoma in situ of the cervix.\n22. Receiving any other investigational treatment for any indication ≤ 3 weeks prior to enrollment.\n23. Unwillingness or inability to follow protocol requirements.\n24. Any condition that, in the opinion of the Investigator, would interfere with evaluation of REM-422 or interpretation of the participant's safety or study results.",{"count":142,"type":22},[60],"The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed\u002Frefractory AML",[31,339,65,29],"Higher Risk Myelodysplastic Syndromes","2025-04-18",{"date":342,"type":40},"2025-04-23",{"date":344,"type":40},"2024-04-26",{"date":346,"type":22},"2027-06-15",{"name":348,"class":158},"Remix Therapeutics",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":360,"conditions":361,"keywords":362,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":48},"100531549","early-phase-1-off-the-shelf-cd123-car-nk-for-rr-aml-100531549","NCT06201247","Off-the-shelf CD123 CAR-NK for R\u002FR AML","Safety and Efficacy of Universal Off-the-shelf CAR-NK Cells Targeted CD123 (JD123 Injection) in the Treatment of Refractory or Relapsed CD123-positive Acute Myeloid Leukemia","Inclusion criteria:\n\n1. Age ≥ 18 years old, no gender or race;\n2. Expected survival period ≥ 3 months;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;\n4. The diagnosis of AML with bone marrow biopsy, immunohistochemistry or Flow cytometry definitively positive for CD123 and met the following criteria:\n\n   A. Diagnostic criteria for relapsed AML: after complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration; B. Diagnostic criteria for refractory AML: naive patients who were ineffective after 2 courses of standard regimens; patients relapsed within 12 months who underwent consolidation and intensive therapy after CR; patients relapsed after 12 months but were ineffective after conventional chemotherapy; Patients with two or more relapses; patients with persistent extramedullary leukemia; Patients relapsed after allogeneic hematopoietic stem cell transplantation (allo-HSCT) C. Minimal Residual Disease (MRD) positive only or relapse: Patient is minimal residual disease (MRD) positive, as assessed on bone marrow aspirate (BMA) by Multiparameter Flow Cytometry (MFC) at time of Treatment Eligibility assessment.\n5. Adequate organ function:\n\nA. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL\u002Fmin; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; 6. Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.; 7. Informed Consent\u002FAssent: All subjects must have the ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n1. Active Central nervous system leukemia;\n2. Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine\u002Fcyclophosphamide;\n3. Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids);\n4. Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.\n5. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;\n6. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;\n7. Women who are pregnant (urine\u002Fblood pregnancy test positive) or lactating;\n8. Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness;\n\n10\\. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.\n\n\\-",{"count":357,"type":22},12,[359],"EARLY_PHASE1","This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (AML).",[66,29],[65,363],"CAR-NK","2025-03-08",{"date":366,"type":40},"2025-03-11",{"date":368,"type":40},"2023-12-30",{"date":370,"type":22},"2025-12-30",{"name":372,"class":47},"Peking University People's Hospital",{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":394},"100453894","phase-1-a-clinical-trial-of-bp1002-in-patients-with-refractoryrelapsed-acute-myeloid-leukemia-aml-100453894","NCT05190471","A Clinical Trial of BP1002 in Patients With Refractory\u002FRelapsed Acute Myeloid Leukemia (AML)","A Phase I\u002FIb Study of BP1002 (a Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in Patients With Refractory\u002FRelapsed Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. Adults ≥18 years of age, with histologic evidence of refractory\u002Frelapsed AML who have failed treatment with available therapies known to be active for refractory\u002Frelapsed AML\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 or 2\n3. For the dose expansion phase, participants with documented diagnosis of AML who are eligible for decitabine therapy\n4. Participants must have adequate hepatic and renal functions as defined by:\n\n   1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and\n   2. Usually total bilirubin ≤ 1.5 ULN. In specific cases the PI may request a waiver of this requirement with medical justification and agreement with the medical monitor and Bio-Path Holdings. And;\n   3. Estimated creatinine clearance of at least 60 mL\u002Fmin. These estimations are calculated using the Cockcroft-Gault equation.\n5. Female participants of childbearing potential must agree to use an acceptable method of birth control (i.e. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the duration of the study and for at least 6 months after the last dose of study drug or decitabine\n6. Male participants must agree to use an acceptable method of contraception for the duration of the study\n7. Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment\n8. Participants must be willing and able to provide written informed consent\n\nExclusion Criteria:\n\n1. Active non-hematologic or lymphoid malignancy other than AML treated with immunotherapy, targeted therapy or chemotherapy within the previous 12 months\n2. Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Participants with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening\n3. Isolated potentially treatable extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually ≥ 5% blasts in BMA or biopsy). Participants may have leukemia with lower blast counts (Döhner 2017). Bio-Path Holdings and Investigator concurrence required.\n4. Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA\n5. Chronic myeloid leukemia in any phase\n6. Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or leukapheresis\n7. Participants may not be receiving any other investigational agents\n8. Female participants who are pregnant or breast-feeding\n9. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n10. Participants with human immunodeficiency virus (HIV) infection who have CD4+ T-cell counts \\\u003C 350 cells\u002FmcL or with clinically active hepatitis B or C infection\n11. History of any hypersensitivity to hypomethylating agents, unless reaction is deemed irrelevant to the study by the Investigator and Medical Monitor\n12. Unresolved toxicity higher than CTCAE Grade 1 attributed to any prior therapy or procedure, excluding alopecia\n13. Presence of concurrent conditions that, in the opinion of the Investigator and\u002For Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant baseline ECG abnormality (e.g., QTcF \\>470 msec)\n14. Within the past 6 months, has had any of the following: myocardial infarction, unstable angina pectoris, coronary\u002Fperipheral artery bypass graft, cerebrovascular accident or transient ischemic attack\n15. Uncontrolled seizure disorder (i.e., seizures within the past 2 months)\n16. Unable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reason",{"count":381,"type":22},48,[60],"This study evaluates the safety and tolerability of escalating doses of BP1002 (Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in patients with refractory\u002Frelapsed AML. The study is designed to assess the safety profile, identify DLTs, biologically effective doses, PK, PD and potential anti-leukemic effects of BP1002 as single agent (dose escalation phase) followed by assessing BP1002 in combination with decitabine (dose expansion phase).",[66,29],"2025-03-06",{"date":387,"type":40},"2025-03-10",{"date":389,"type":40},"2022-08-16",{"date":391,"type":22},"2027-09",{"name":393,"class":158},"Bio-Path Holdings, Inc.",4,{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":406,"conditions":407,"keywords":408,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":419},"100481252","phase-1-study-of-iadademstat-and-gilteritinib-in-patients-with-rr-aml-with-fms-like-tyrosine-kinase-mutation-flt3-mut-100481252","NCT05546580","Study of Iadademstat and Gilteritinib in Patients With R\u002FR AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)","An Escalation\u002FExpansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R\u002FR AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study","FRIDA","Main Inclusion Criteria:\n\n* Diagnosis of primary AML or AML with myelodysplasia-related changes (AML-MRC)\n* Patient is in first or second relapse or has refractory disease. Patients must have had histologic verification of AML at the original diagnosis.\n* Patient must be positive for the following FLT3 mutations in bone marrow or PB: FLT3 internal tandem duplication (ITD), FLT3 tyrosine kinase domain (TKD) D835 or I836 or FLT3-ITD and specified FLT3-TKD.\n* ECOG performance status 0-2\n* Life expectancy of at least 3 months in the opinion of the investigator.\n* Normal hepatic and renal function.\n* Patient is able to swallow oral medications.\n* Female patients are postmenopausal, documented as surgically sterile, use two methods of contraception or practice true abstinence and have a negative urine pregnancy test at screening.\n* Male patients even if surgically sterilized agree to practice true abstinence or use highly effective barrier contraception.\n\nMain Exclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia.\n* Known BCR-ABL-positive leukemia.\n* AML secondary to prior chemotherapy for other neoplasms (except for MDS).\n* AML that has relapsed after or is refractory to more than 2 lines of therapy.\n* Clinically active central nervous system leukemia or prior history of NCI CTCAE Grade ≥ 3 drug-related CNS toxicity.\n* Major surgery or radiation therapy within 4 weeks prior to the first study dose.\n* Prior treatment with iadademstat is not allowed. Treatment with any other agents with KDM1A\u002FLSD1 inhibitory activity is only allowed if treatment finalized at least 3 weeks prior to first dose on study. Previous treatment with FLT3 inhibitors is allowed in the following cases: midostaurin and sorafenib are allowed when used in first-line therapy regimen as part of induction, consolidation and\u002For maintenance: quizartinib and gilteritinib are allowed when used in first-line therapy regimen, as part of induction, consolidation and\u002For maintenance, ONLY if patients were not refractory to the drugs or if responding, relapse did not occur while on these drugs.\n* Patients not eligible to receive gilteritinib per label.\n* Prior treatment with 3 or more lines of AML therapy.\n* Treatment with any investigational products within 3 weeks prior to first dose of study treatment.\n* Uncontrolled hypertension or poorly controlled diabetes.\n* Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.\n* Pregnant or lactating women.",{"count":404,"type":22},50,[60],"Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R\u002FR AML) with FMS-like tyrosine kinase mutation (FLT3 mut+). During the trial, iadademstat will be given in combination with gilteritinib, a drug that is already approved to treat patients with FLT3-mutated R\u002FR AML.",[66,29],[409],"Acute Myeloid Leukemia, FLT3 mut","2024-07-26",{"date":412,"type":40},"2024-07-29",{"date":414,"type":40},"2022-11-14",{"date":416,"type":22},"2025-11-30",{"name":418,"class":158},"Oryzon Genomics S.A.",13,{"id":421,"slug":422,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":427,"targetDuration":4,"studyType":23,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":436,"leadSponsor":438,"locationsCount":48},"100525739","phase-1-administration-of-anti-tim-3cd123-car-t-cell-therapy-in-relapsed-and-refractory-acute-myeloid-leukemia-rraml-100525739","NCT06125652","Administration of Anti Tim-3\u002FCD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr\u002FAML)","Application of Anti Tim-3\u002FCD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr\u002FAML)","Inclusion Criteria:\n\n1. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;\n2. At the age of 18-70 years old;\n3. Diagnosed as relapse\u002Frefractory (r\u002Fr) de novo or secondary acute myeloid leukemia (AML);\n4. The patient has recovered from the toxicity of previous treatment;\n5. ECOG score ≤ 2 and expected survival period is not less than 3 months;\n6. Adequate organ function defined as:AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL\u002Fmin; Hemoglobin ≥60g\u002FL ; Indoor oxygen saturation ≥92%; LVEF≥45%;\n7. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;\n8. From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception.\n\nExclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia;\n2. History or presence of a CNS disorder;\n3. HBsAg is positive; HCV #HIV or Syphilis antibody are positive, CMV-DNA in peripheral blood is more than≥500 copies \u002FmL;\n4. History of severe hypersensitivity reaction;\n5. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;\n6. History of organ transplant surgery;\n7. Required systemic application of immunosuppressive or other drugs;\n8. Auto-SCT within the 3 months before enrollment;\n9. Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES));\n10. Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ;\n11. Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management;\n12. Live vaccine received within the ≤ 4 weeks before enrollment;\n13. Persons with serious mental illness;\n14. History of major surgical operations four weeks before enrollment;\n15. History of alcoholism or substance abuse;\n16. Was identified by the investigators as unsuitable to participate in the study.",{"count":428,"type":22},20,[60,25],"To evaluate the safety and efficacy of anti Tim3\u002FCD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.",[29,66],"2023-11-04",{"date":434,"type":40},"2023-11-09",{"date":432,"type":40},{"date":437,"type":22},"2027-01-01",{"name":439,"class":47},"Xuzhou Medical University",{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":456,"locationsCount":458},"100478158","phase-1-treatment-with-abt-199-venetoclax-and-purine-analogues-in-relapsedrefractory-acute-myeloid-leukemia-100478158","NCT05506332","Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed\u002FRefractory Acute Myeloid Leukemia","ABT-199 (Venetoclax) and Purine Analogues as Novel Oral Drug Combination for Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia: the ApoAML Trial","Inclusion Criteria:\n\n* Relapsed or refractory AML\n* Relapsed after or refractory to at least one cycle of intensive chemotherapy (combination of ara-c\u002Fanthracyclin) or four cycles of HMA (hypomethylating agents)\n* Adult AML aged \\>\u002F= 18 years\n* WHO performance status: grade 0-2 at the time of enrollment\n* ABT-199 (venetoclax) and PA-naïve. Patient may be prior exposed but not refractory to venetoclax. In case of previous therapy with venetoclax inclusion is only possible after discussion with the PI.\n\nExclusion Criteria:\n\n* Participation in any other interventional clinical trial during the study period\n* Active presence (or known history of) central nervous system disease\n* History or concomitant presence of any other malignancy, except for non-melanoma skin cancer, carcinoma in situ of the cervix, any other effectively treated malignancy that has been in remission for \\>5 years or that is highly likely to be cured at the time of enrollment.\n* Active HIV, hepatitis B or hepatitis C infection\n* Use of any antitumoral agent within less than 5 times the half-life of the agent prior to the screening bone marrow examination. After the screening bone marrow examination, the use of cytoreductive treatment prior to the initiation of venetoclax is permitted in order to lower the WBC-count to \\\u003C25 000\u002Fµl (e.g. hydroxyurea).\n* Medical conditions requiring chronic therapy of moderate or strong CYP3A4 inducers without alternative\n* Patients with known hypersensitivity to the active substance or to any of the excipients\n* Pregnant or breastfeeding woman\n* Active uncontrolled systemic infection",{"count":279,"type":22},[60],"Non-commercial, open-label interventional phase Ib study to assess the effectivity of the combination of venetoclax and 6-mercaptopurine in patients with relapsed or refractory AML.",[66,29],{"date":452,"type":40},"2022-08-18",{"date":454,"type":40},"2022-07-15",{"date":276,"type":22},{"name":457,"class":47},"University Hospital, Antwerp",2]