[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Celyad Oncology SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,62],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100438643","phase-1-study-of-pembrolizumab-treatment-after-cyad-101-with-folfox-preconditioning-in-metastatic-colorectal-cancer-100438643",false,"NCT04991948","Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer","An Open-label, Phase Ib Study to Assess the Safety and Clinical Activity of CYAD-101 Administered Concurrently With FOLFOX Chemotherapy, Followed by Pembrolizumab Treatment, in Patients With Metastatic Colorectal Cancer","Key Inclusion Criteria:\n\n1. Histologically proven metastatic adenocarcinoma of the colon or rectum.\n\n   1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.\n   2. Confirmed non-microsatellite instability high (non-MSI-H)\u002Fmismatch-repair proficient (pMMR) tumor status\n   3. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n   4. Recurrent\u002Fprogressing disease after at least one line of systemic therapy for metastatic disease which must include FOLFOX chemotherapy\n   5. The patient is due to receive FOLFOX chemotherapy\n   6. Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n3. Adequate organ, hepatic, renal, pulmonary and cardiac functions\n4. Tumor biopsy at screening\n\nKey Exclusion Criteria:\n\n1. Any other investigational agent or device within 4 weeks of the first study treatment administration.\n2. Any anticancer agent within 4 weeks of the first study treatment administration\n3. Filgrastim (Granulocyte-Colony-Stimulating Factor \\[G-CSF\\]) or similar growth factors within 7 days of the first study treatment administration\n4. Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor\n5. Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration\n6. Major surgery within 4 weeks before the planned day for the first study treatment administration\n7. A live vaccine within 30 days prior to the planned day for the first study treatment administration\n8. Uncontrolled intercurrent illness or serious uncontrolled medical disorder\n9. Patients with history of (non-infectious) pneumonitis that require steroids or has current pneumonitis as assessed by chest imaging within 48 hours prior to first study treatment administration.","ALL","18 Years",{"count":19,"type":20},34,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of the CYAD-101-002 study is to assess the safety and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment.",[26],"Unresectable Metastatic Colorectal Cancer","RECRUITING","2022-02-22",{"date":30,"type":31},"2022-03-09","ACTUAL",{"date":33,"type":31},"2021-11-22",{"date":35,"type":20},"2038-05-25",{"name":37,"class":38},"Celyad Oncology SA","INDUSTRY",5,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100338895","phase-1-alloshrink---standard-chemotherapy-regimen-and-immunotherapy-with-allogeneic-nkg2d-based-cyad-101-chimeric-antigen-receptor-t-cells-100338895","NCT03692429","alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells","An Open-label, Phase I Study to Assess the Safety of Multiple Doses of CYAD-101, Administered After Standard FOLFOX or FOLFIRI Chemotherapy in Patients With Unresectable Metastatic Colorectal Cancer","alloSHRINK","Inclusion Criteria:\n\n1. Histologically proven metastatic adenocarcinoma of the colon or rectum.\n\n   1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.\n   2. Recurrent\u002Fprogressing disease after at least one line of systemic therapy for metastatic disease.\n   3. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n   4. FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.\n   5. FOLFIRI segment: Documented progressive disease (PD) under FOLFIRI treatment, with or without targeted therapy, given within 3 months prior to study registration. Anti-cancer therapy post FOLFIRI-documented PD prior to study registration is authorized if discontinued at least 7 days before the planned study registration. Radiotherapy is not authorized.\n2. The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n3. The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.\n\nExclusion Criteria:\n\n1. The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).\n2. Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.\n3. Filgrastim (Granulocyte-Colony-Stimulating Factor \\[G-CSF\\]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration.\n4. Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.",{"count":49,"type":20},49,[23],"The purpose of the alloSHRINK study is to assess the safety, cell kinetics and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered after standard chemotherapy",[26],"2020-11-19",{"date":55,"type":31},"2020-11-20",{"date":57,"type":31},"2018-11-28",{"date":59,"type":20},"2036-02-17",{"name":37,"class":38},4,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":39},"100375376","phase-1-study-in-relapsedrefractory-acute-myeloid-leukemia-or-myelodysplastic-syndrome-patients-to-determine-the-recommended-dose-of-cyad-02-100375376","NCT04167696","Study in Relapsed\u002FRefractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02","Open-label, Phase I, Multi-center Study to Determine in Relapsed\u002FRefractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients the Recommended Dose of CYAD-02 After a Non-myeloablative Preconditioning Chemotherapy Followed by a Potential Consolidation Cycle","CYCLE-1","Inclusion Criteria (main):\n\n* The patient must not be eligible for standard of care therapy and have one of the following hematological malignancy:\n\n  1. A confirmed relapsed or refractory acute AML (i.e. ≥ 5% blasts in bone marrow or in peripheral blood) with revised European LeukemiaNet (ELN) 2017 risk stratification for favorable, intermediate or adverse groups, after at least one prior therapy defined as either\n\n     * Recurrence of disease after a first complete remission and not eligible for a second course of induction therapy, or\n     * Recurrence of disease after a second complete remission, or\n     * Failure to achieve a Complete Response after induction chemotherapy.\n  2. A confirmed MDS as defined by revised International Prognostic Scoring System criteria for intermediate, high-risk or very high-risk disease or MDS with Tumor Protein 53 mutation as detected by next-generation sequencing, after failure of prior treatment with at least 4 cycles of azacitidine or decitabine defined as:\n\n     * No response to treatment,\n     * Loss of response at any time point, or\n     * Intolerance to therapy.\n* The patient must have evaluable disease as defined by:\n\n  * Revised Recommendations of the International Working Group (IWG) for Diagnosis, Standardization of Response Criteria for AML patients,\n  * IWG 2006 Uniform Response Criteria for patients with MDS.\n* The absolute peripheral blast count should be \\\u003C 15,000\u002FL.\n* The patient must have adequate hepatic and renal functions, as assessed by standard laboratory criteria.\n* The patient must have a left ventricular ejection fraction of ≥ 40 %, as determined by echocardiography or a multigated acquisition scan.\n* The patient must have a Forced Expiratory Volume (FEV) in the first second \u002FForced Vital Capacity = 0.7 with FEV-1 at 50 % predicted (GOLD 1 or 2 severity) as determined by spirometry\n\nExclusion Criteria (main):\n\n* Patients with a confirmed or history of tumor involvement in the central nervous system\n* Patients who have received any cancer therapy with therapeutic intent (investigational agent or not)\n* Patients with any positive serology test results at baseline\n* Patients who plan to receive, are concurrently receiving or have received any investigational agent within 3 weeks before the planned day for the first CYAD-02 infusion\n* Patients with uncontrolled intercurrent illness or serious uncontrolled medical disorder\n* Patients with significant coagulation disorder or who are receiving treatment with warfarin derivatives, heparin or direct oral anticoagulants\n* Patients who have active infections\n* Patients with documented history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis and\u002For active or acute exacerbation of chronic obstructive pulmonary disease",{"count":71,"type":20},27,[23],"An open-label, phase I, multi-center study to determine in relapsed\u002Frefractory (r\u002Fr) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-02 consolidation cycle for non-progressive patient. A maximum of 27 r\u002Fr AML\u002FMDS patients will be evaluated in this study in case of no dose limiting toxicity (DLT) and no replacement of patients.",[75,76],"Acute Myeloid Leukemia","Myelodysplastic Syndrome","2020-06-08",{"date":79,"type":31},"2020-06-09",{"date":81,"type":31},"2019-11-25",{"date":83,"type":20},"2035-02",{"name":37,"class":38},""]