[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100386972":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":53,"centralContacts":59,"locations":64,"responsibleParty":89,"collaborators":46,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":46,"eligibilityCriteria":96,"healthyVolunteers":93,"sex":97,"minAge":46,"maxAge":98,"enrollmentInfo":99,"targetDuration":46,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":111,"overallStatus":67,"whyStopped":46,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8,17],{"label":9,"type":6,"description":10,"interventionNames":11},"ARM A CD123-CAR T cell therapy","For patients who have not received an allogeneic transplant or for patients who have received allogeneic transplant and do not have a transplant donor available\n\nCD123-CAR T-cell dose and infusion Up to 4 Dose levels will be evaluated with a maximum dose of 2.5 x 10\\^8 CAR+ T cells. If dose limiting toxicities (DLTs) are observed on Dose level 1 then the cell dose is de- escalated.",[12,13,14,15,16],"Drug: CD123-CAR T","Drug: Cyclophosphamide","Drug: Fludarabine","Drug: Mesna","Drug: Rituximab",{"label":18,"type":19,"description":20,"interventionNames":21},"ARM B CD123-CAR T cell therapy","EXPERIMENTAL","For patients who relapsed following allogeneic transplant and whose CAR T-cells will be manufactured from the previous transplant donor, when available.\n\nCD123-CAR T-cell dose and infusion Up to 4 Dose levels will be evaluated with a maximum dose of 2.5 x 10\\^8 CAR+ T cells. If dose limiting toxicities (DLTs) are observed on Dose level 1 then the cell dose is de- escalated.",[12,13,14,15,16],[23,30,36,42,47],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","CD123-CAR T","To treat relapsed\u002Frefractory CD123+ AML\u002FMDS, B-ALL, T-ALL or BPDCN patient population that needs new cancer-directed therapies.",[9,18],[29],"CD123-CAR T cells",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Cyclophosphamide","Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.",[9,18],[35],"Cytoxan",{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Fludarabine","Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis",[9,18],[41],"Fludara",{"type":24,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Mesna","Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide",[9,18],null,{"type":24,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Rituximab","Rituximab is a monoclonal antibody directed against the CD20 antigen on the surface of B-lymphocytes",[9,18],[52],"Rituxan",[54,57],{"name":55,"affiliation":5,"role":56},"Swati Naik, MD","PRINCIPAL_INVESTIGATOR",{"name":58,"affiliation":5,"role":56},"Paulina Velasquez, MD",[60],{"name":55,"role":61,"phone":62,"phoneExt":46,"email":63},"CONTACT","888-226-4343","referralinfo@stjude.org",[65,82],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"St Jude Children's Research Hospital","RECRUITING","Memphis","Tennessee","38105","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-90.04898,35.14953,{"lat":77,"lon":76},[80,81],{"name":55,"role":61,"phone":62,"phoneExt":46,"email":63},{"name":55,"role":56,"phone":46,"phoneExt":46,"email":46},{"facility":5,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},{"type":74,"coordinates":84},[76,77],{"lat":77,"lon":76},[87,88],{"name":58,"role":61,"phone":62,"phoneExt":46,"email":63},{"name":58,"role":56,"phone":46,"phoneExt":46,"email":46},{"type":90,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100386972","phase-1-cd123-directed-t-cell-therapy-for-acute-myelogenous-leukemia-catchaml-100386972",false,"NCT04318678","CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)","Inclusion Criteria for Procurement and T-cell Production:\n\n* Age ≤21 years old\n* Relapsed\u002Frefractory CD123+ disease defined as follows:\n\nAML\u002FMDS\n\n* Relapsed disease: Patients developing recurrent disease after a first complete remission (CR)\n* Refractory disease: Patients not achieving a CR after 2 cycles of induction chemotherapy\n\nB-cell ALL\n\n* Relapsed disease that is CD123 positive and CD19 negative\u002Fdim or patients otherwise ineligible for CD19 directed therapies including\n\n  * Patients in 2nd or greater relapse\n  * Patients with relapse after allogeneic HSCT\n* Refractory disease that is CD123 positive and CD19 negative\u002Fdim or patients otherwise ineligible for CD19 directed therapies\n\nT-cell All • Relapsed refractory disease that is CD123 positive\n\nBPDCN\n\n• Relapsed\u002Frefractory disease that has failed front-line therapy\n\n* Estimated life expectancy of \\>12 weeks\n* Karnofsky or Lansky (age-dependent) performance score ≥50\n* Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis\n* Patient must have an identified, suitable HCT donor\n* For females of child-bearing age:\n* Not lactating with intent to breastfeed\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* History of HIV infection\n* Severe intercurrent uncontrolled bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)\n* History of hypersensitivity reactions to murine protein-containing products\n* Patients with acute promyelocytic leukemia (APL, t (15;17))\n* Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine\u002Fcyclophosphamide.\n\nInclusion Criteria for Treatment:\n\n* Age≤21 years old\n* Detectable disease that is CD123+ (at least MRD+ disease)\n* Estimated life expectancy of \\>8 weeks\n* Karnofsky or Lansky (age-dependent) performance score≥50\n* Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to planned infusion\n* Patient must have an identified, suitable HCT donor\n* Adequate cardiac function defined as left ventricular ejection fraction \\>40%, OR shortening fraction ≥25%\n* EKG without evidence of clinically significant arrhythmia\n* Adequate renal function defined as creatinine clearance or radioisotope GFR ≥50 ml\u002Fmin\u002F1.73m2 (GFR ≥40 ml\u002Fmin\u002F1.73m2 if \\\u003C 2 years of age)\n* Adequate pulmonary function defined as forced vital capacity (FVC)≥50% of predicted value; or pulse oximetry≥92% on room air if patient is unable to perform pulmonary function testing\n* Total Bilirubin≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome\n* Alanine aminotransferase (ALT) OR aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age\n* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy\n* For females of child-bearing age\n\n  * Not lactating with intent to breastfeed\n  * Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* If sexually active, agreement to use birth control until 3 months after T- cell infusion. Male partners should use a condom.\n* Available autologous transduced T-cell product that has met GMP release criteria\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* History of HIV infection\n* Severe intercurrent uncontrolled bacterial, viral or fungal infection\n* History of hypersensitivity reactions to murine protein-containing products\n* History of severe hypersensitivity reactions to cornstarch or hydroxyethyl starch.\n* Receiving systemic steroids therapy exceeding the equivalent of 0.5 mg\u002Fkg\u002Fday of methylprednisolone, in the 7 days prior to CD123-CAR T- cell infusion\n* Receiving systemic therapy in the 14 days prior to CD123-CAR T-cell infusion, which will interfere with the activity of the CD123-CAR T cells in vivo (in the opinion of the study PI(s))\n* Receiving rituximab therapy in the 30 days prior to CD123-CAR T cell infusion. (This exclusion criterion is intended to prevent premature exposure of CD123-CAR T cells to rituximab, which would activate the safety switch and promote CAR T-cell apoptosis).\n* Receiving intrathecal chemotherapy in the 7 days prior to CD123-CAR T cell infusion.\n* Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine\u002Fcyclophosphamide.\n* Active CNS disease","ALL","21 Years",{"count":100,"type":101},108,"ESTIMATED","INTERVENTIONAL",[104],"PHASE1","The CD123-CAR T-cell therapy is a new treatment that is being investigated for treatment of AML\u002Fmyelodysplastic syndrome (MDS), T- or B- acute lymphoblastic leukemia (ALL) or blastic plasmacytoid dendritic cell neoplasia (BPDCN). The purpose of this study is to find the maximum (highest) dose of CD123-CAR T cells that is safe to give to these patients. This would include studying the side effects of the chemotherapy, as well as the CD123-CAR T-cell product on the recipient's body, disease and overall survival.\n\nPrimary Objective:\n\n* To determine the safety of one intravenous infusion of escalating doses of autologous, CD123-CAR T cells in patients (≤21 years) with recurrent\u002Frefractory CD123+ disease (AML\u002FMDS, B-ALL, T-ALL or BPDCN) after lymphodepleting chemotherapy.\n* To determine the safety of an intravenous infusion of escalating doses of donor derived, CD123-CAR T cells in patients (≤21 years) with recurrent\u002Frefractory CD123+ disease (AML\u002FMDS, B-ALL, T-ALL, BPDCN or MPAL) after lymphodepleting chemotherapy.\n\nSecondary Objectives\n\n\\- To evaluate the antileukemia activity of CD123-CAR T cells.\n\nExploratory Objectives\n\n* To assess the immunophenotype, clonal structure and endogenous repertoire of CD123-CAR T cells and unmodified T cells\n* To characterize the cytokine profile in the peripheral blood and CSF after treatment with CD123-CAR T cells\n* To characterize tumor cells post CD123-CAR T-cell therapy\n* To compare in vivo properties of donor-derived versus autologous CD123- CAR T cells",[107,108,109,110],"AML\u002FMDS","B-ALL","T-ALL","BPDCN",[112],"CD123+","2026-05-18",{"date":115,"type":116},"2026-05-19","ACTUAL",{"date":118,"type":116},"2020-07-29",{"date":120,"type":101},"2030-07-29",{"name":5,"class":6},2]