[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490901":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":33,"centralContacts":37,"locations":38,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":37,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":37,"enrollmentInfo":74,"targetDuration":37,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":37,"overallStatus":40,"whyStopped":37,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (anti-CD33 CAR T-cells)","EXPERIMENTAL","Patients undergo lymphodepletion therapy 3-5 days prior to CAR T cell infusion and receive anti-CD33 CAR T-cells IV on day 0. Patients with persistent CD33+ AML who are \\> 28 days past the initial CAR T infusion, have additional product available and did not experience a dose-limiting toxicity, may optionally receive anti-CD33 CAR T-cells IV.",[13,14],"Biological: Anti-CD33 CAR T-cells","Procedure: Lymphodepletion Therapy",[16,25],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","Anti-CD33 CAR T-cells","Given IV",[9],[22,23,24],"Anti-CD33 CAR T Cells","Anti-CD33 CAR-T Cells","CD33-CAR T Cells",{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Lymphodepletion Therapy","Undergo lymphodepletion",[9],[31,32],"Lymphodepleting Therapy","Lymphodepletion",[34],{"name":35,"affiliation":5,"role":36},"Karamjeet S Sandhu","PRINCIPAL_INVESTIGATOR",null,[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Duarte","California","91010","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-117.97729,34.13945,{"lat":50,"lon":49},[53,58],{"name":54,"role":55,"phone":56,"phoneExt":37,"email":57},"Karamjeet S. Sandhu","CONTACT","626-218-2405","ksandhu@coh.org",{"name":54,"role":36,"phone":37,"phoneExt":37,"email":37},{"type":60,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[62],{"name":63,"class":64},"National Cancer Institute (NCI)","NIH","100490901","phase-1-cd33-car-t-cell-therapy-for-the-treatment-of-recurrent-or-refractory-acute-myeloid-leukemia-100490901",false,"NCT05672147","CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia","Phase I Study of Cellular Immunotherapy Using T Cells Lentivirally Transduced to Express a Cd33-Specific Chimeric Antigen Receptor for Patients With Cd33+ Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n  * For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening, while the request for a translated full consent is processed\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with Study principal investigator (PI) approval\n* Age: \\>= 18 years\n* Karnofsky Performance Scale (KPS) \\>= 70\n* Life expectancy \\>= 16 weeks at the time of enrollment\n* Prior allogeneic transplant allowed if \\> 6 months prior to study enrollment\n* Participant must have a confirmed diagnosis of active CD33+ AML de novo, or secondary OR participants who are at a high risk for disease recurrence\n\n  * Relapsed AML is defined as patients that had a first complete response (CR) before developing recurrent disease (increased bone marrow blasts)\n  * Refractory AML is defined as patients that have not achieved a first CR after induction chemotherapy. For patients with AML evolving from myelodysplastic syndrome, they should have completed at least one cycle of induction chemotherapy\n* Research participants must have bone marrow and\u002For peripheral blood samples available for confirmation of diagnosis of AML\n\n  * CD33 positivity must be confirmed by either flow cytometry or immunohistochemistry within 90 days of study entry. Cytogenetics, flow cytometry, and molecular studies (such as FLT-3 status) will be obtained as per standard practice\n  * Research participants who are at a high risk of disease recurrence, they must have historical bone marrow and\u002For peripheral blood samples available for confirmation of diagnosis of AML\n* No known contraindications to lymphodepleting agents, steroids, tocilizumab and\u002For cetuximab, or the investigational agent\n* Total serum bilirubin =\\\u003C 2.0 mg\u002FdL\n* Participants with Gilbert syndrome may be included if their total bilirubin is =\\\u003C 3.0\n* Aspartate aminotransferase (AST) =\\\u003C 3 x the upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) =\\\u003C 3 x ULN\n* Estimated creatinine clearance of \\>= 60 mL\u002Fmin per the Cockcroft-Gault formula, and the participant is not on hemodialysis\n* Left ventricular ejection fraction \\>= 50% within 8 weeks before enrollment\n* Oxygen (O2) saturation \\> 92% not requiring oxygen supplementation\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* Research participants must have a potential donor or stem cell source identified for allogeneic transplantation, either related (7\u002F8 or 8\u002F8 allele matched or haploidentical)\n* DONOR: The identified donor must be the original donor whose stem cells were used for the research participant's allogeneic hematopoietic stem cell transplantation (alloSCT)\n* DONOR: The donor must be HIV negative\n* DONOR: KPS \\>= 70\n* DONOR: Documented body weight\n\nExclusion Criteria:\n\n* Prior allogeneic transplant if \\\u003C 6 months prior to enrollment\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications should be stopped 28-days prior to enrollment. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =\\\u003C 7.5 mg\u002Fday, or equivalent doses of other corticosteroids) is allowed\n* Participants with active autoimmune disease, including graft versus host disease (GvHD), requiring systemic immune suppressive should be stopped 28-days prior to enrollment\n* Participants may not be receiving any other investigational agents and are not dependent on concurrent biological therapy, chemotherapy, or radiation therapy\n\n  * With exception to Hydrea which must be stopped prior to initiation of lymphodepletion\n* Research participants on active systemic antifungal treatment within 8 weeks of enrollment are not eligible. However, participants on antifungal prophylaxis are eligible\n\n  * Not applicable at the time of enrollment if the research participant's donor is undergoing leukapheresis\n* Subjects with \\>= Grade 2 myelofibrosis on bone marrow biopsy\n* Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening if the patient is undergoing leukapheresis. Patients with controlled atrial arrythmia is allowed\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* History of stroke or intracranial hemorrhage within 6 months prior to screening\n* Subjects with presence of other active malignancy, however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics\n* Research participants who have tested human immunodeficiency virus (HIV) positive, or have active hepatitis B or C infection based on testing performed within 4 weeks of enrollment\n* Active viral hepatitis\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","ALL","18 Years",{"count":75,"type":76},27,"ESTIMATED","INTERVENTIONAL",[79],"PHASE1","This phase I trial tests the safety, side effects, and the best dose of anti-CD33 chimeric antigen receptor (CAR) T-Cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient or donor's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's or donor's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers.",[82,83,84,85],"Acute Myeloid Leukemia","Recurrent Adult Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","Secondary Acute Myeloid Leukemia","2026-03-03",{"date":88,"type":89},"2026-03-05","ACTUAL",{"date":91,"type":89},"2023-12-07",{"date":93,"type":76},"2028-09-03",{"name":5,"class":6},1]