[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100469337":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":29,"collaborators":20,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":35,"acronym":36,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":20,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":54,"whyStopped":20,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":20},{"fullName":5,"class":6},"University College, London","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm Trial","EXPERIMENTAL","Treatment with Lymphodepletion followed by a dose of KCAT19 T cells.",[13],"Genetic: KCAT19 T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"GENETIC","KCAT19 T cells","Allogeneic, cord unit derived KCAT19 T cells",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"David Gear","CONTACT","0207 670 5748","ctc.kcat19@ucl.ac.uk",{"name":28,"role":24,"phone":20,"phoneExt":20,"email":26},"Alex Day",{"type":30,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100469337","phase-1-allogeneic-t-cells-expressing-t-cell-receptor-kdel-and-the-chimeric-antigen-receptor-cat19-for-the-treatment-of-advanced-cd19-malignancies-100469337",false,"NCT05391490","Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies","KCAT19","Inclusion Criteria:\n\n1. Age 16-65 years\n2. Relapsed or refractory B cell malignancy following at least 2 prior lines of therapy:\n\n   B-ALL: relapsed or refractory B-ALL following standard therapy, requiring salvage, in whom alternative therapies are deemed inappropriate by their treating physician Or LBCL: relapsed\u002Frefractory DLBCL (incl. transformed FL but not Richter's transformation) or PMBCL following ≥2 prior lines of therapy which must include Rituximab, anthracycline and autologous CD19 CAR, (unless CD19 CAR cannot be manufactured) Or MCL: relapsed\u002F refractory disease following ≥2 lines of therapy which must include Rituximab, Bruton's tyrosine kinase inhibitor and autologous CD19CAR therapy (unless CD19 CAR cannot be manufactured) Or Indolent B-NHL (either Follicular Lymphoma, Marginal Zone Lymphoma or other low-grade lymphoma) which is relapsed \u002F refractory following ≥2 prior lines of therapy which must include anti-CD20 therapy and chemotherapy with anthracycline or bendamustine.\n3. CD19+ disease\n4. Agreement to have a pregnancy test, use adequate contraception (if applicable)\n5. Written informed consent\n\nExclusion Criteria:\n\n1. CD19 negative disease\n2. Active CNS involvement of disease\n3. Diagnosis of chronic lymphocytic leukaemia\u002F small lymphocytic lymphoma or Burkitt lymphoma\n4. Active hepatitis B, C or HIV infection\n5. Oxygen saturation ≤ 90% on air\n6. Bilirubin \\>2 x upper limit of normal\n7. GFR \\\u003C30ml\u002Fmin\n8. Women who are pregnant or breast feeding\n9. Stem Cell Transplant patients only: active significant acute GvHD (overall Grade ≥ II, Modified Glucksberg criteria) or moderate\u002Fsevere chronic GvHD (NIH consensus criteria) requiring immunosuppressive therapy and\u002For systemic steroids\n10. Karnofsky score \\\u003C60%\n11. Known allergy to albumin or DMSO\n12. Patients receiving corticosteroids at a dose of \\>5 mg prednisolone per day (or equivalent) that cannot be discontinued\n13. Life expectancy \\\u003C3 months\n14. Cardiac dysrhythmias (excluding well-controlled AF or other supraventricular tachycardia) or significant cardiac disease and left ventricular ejection fraction \\\u003C40%\n15. Patients who can reasonably access autologous CD19 CAR treatment as part of standard of care or a clinical trial\\*\n\n    * These patients will be initially considered for autologous treatment in preference to enrolling on KCAT19","ALL","16 Years","65 Years",{"count":42,"type":43},12,"ESTIMATED","INTERVENTIONAL",[46],"PHASE1","KCAT19 is a single-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age 16-65 years) with high risk, relapsed\u002Frefractory (r\u002Fr) B cell malignancies.",[49],"Blood Cancer",[51,52,53],"CAR T cells","leukemia","lymphoma","NOT_YET_RECRUITING","2022-05-20",{"date":57,"type":58},"2022-05-26","ACTUAL",{"date":60,"type":43},"2022-10",{"date":62,"type":43},"2034-11",{"name":5,"class":6}]