[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Autolus Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":158},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,78,113,134],{"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":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100597077","phase-2-obe-cel-in-severe-refractory-systemic-lupus-erythematosus-sle-with-active-lupus-nephritis-ln-100597077",false,"NCT07053800","Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)","A Single-Arm, Open-Label, Phase II Study to Determine the Safety and Efficacy of Obecabtagene Autoleucel (Obe-cel) in Participants With Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis","LUMINA","Inclusion Criteria:\n\n* Willing and able to give written informed consent for participation in the study or written informed consent signed by a legal guardian or representative\n* Ability and willingness to adhere to protocol's Schedule of Activities and other requirements\n* Participants must be 12 to 65 years of age inclusive at the time of signing the informed consent.\n* Female Participants: - a female participant is eligible to participate if she is not pregnant or breastfeeding\n* Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus.\n* Positive for at least 1 of the following autoantibodies: antinuclear antibodies (ANA), or anti-dsDNA or anti-Smith.\n* Severe, Active SLE defined as:\n\n  * SLEDAI-2K score of ≥ 8 points AND\n  * Severe active LN based on a renal biopsy: Class III, IV or V (V only in combination with class III or IV)\n* Refractory SLE defined as failure to previous lines of therapy\n\nExclusion Criteria:\n\n* Prior treatment at any time with anti-CD19 therapy\n* More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and\u002For makes the immunosuppressive washout impossible\n* Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant\n* History of primary antiphospholipid antibody syndrome\n* Active or uncontrolled fungal, bacterial, or viral infection\n* History of malignant neoplasms unless disease free for at least 24 months\n* History of heart, lung, renal, liver transplant or hematopoietic stem cell transplant","ALL","12 Years","65 Years",{"count":21,"type":22},35,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).",[28],"Lupus Nephritis",[30,31,32,33,34],"Systemic lupus erythematosus","Refractory systemic lupus erythematosus","Lupus nephritis","Obecabtagene autoleucel","Obe-cel","RECRUITING","2026-06-19",{"date":38,"type":39},"2026-06-23","ACTUAL",{"date":41,"type":39},"2026-01-16",{"date":43,"type":22},"2029-10",{"name":45,"class":46},"Autolus Limited","INDUSTRY",10,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100603686","phase-1-obe-cel-in-refractory-progressive-forms-of-multiple-sclerosis-100603686","NCT07139743","Obe-cel in Refractory Progressive Forms of Multiple Sclerosis","A Single-arm, Open-label, Phase I Study to Determine the Safety, Tolerability, and Preliminary Efficacy of Obe-cel in Participants With Refractory Progressive Forms of Multiple Sclerosis","BOBCAT","Inclusion Criteria:\n\n* Willing and able to give written informed consent for participation in the study.\n* Ability and willingness to adhere to the protocol's Schedule of Activities and other requirements.\n* Participants must be 18 to 60 years of age inclusive at the time of signing the informed consent form.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding.\n* Current diagnosis of PMS.\n* Must have been treated previously with 2 disease-modifying therapies.\n\nExclusion Criteria:\n\n* Any medications prohibited by the protocol.\n* Highly active multiple sclerosis.\n* Diagnosis of another autoimmune central nervous system condition.\n* Active or uncontrolled fungal, bacterial, viral infection.\n* History of malignant neoplasms unless disease-free for at least 24 months.\n* History of heart, lung, kidney, liver transplant or hematopoietic stem cell transplant.","18 Years","60 Years",{"count":59,"type":22},18,[61],"PHASE1","The main purpose of this study is to evaluate if obe-cel is safe or causes any side effects in adults with refractory progressive MS. The study also plans to assess if obe-cel can show early signs of efficacy in MS. The trial includes only 1 group of participants (single-arm). The study population comprises participants with progressive forms of MS, not responsive to highly effective therapies.\n\nUpon confirmation of study eligibility, participants will receive chemotherapy (used here for lymphodepletion) over 1 to 3 days in preparation for receiving a single obe-cel infusion.\n\nParticipants will be checked closely in the 28 days following obe-cel treatment. After this, participants will be monitored to evaluate safety and efficacy up to 24 months.",[64],"Progressive Multiple Sclerosis",[66,67,68,33,34],"Multiple sclerosis","Refractory multiple sclerosis","Progressive multiple sclerosis","2026-03-20",{"date":71,"type":39},"2026-03-23",{"date":73,"type":39},"2025-08-04",{"date":75,"type":22},"2029-08-15",{"name":45,"class":46},7,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":56,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},"100529418","phase-1-a-study-of-cd19-targeted-car-t-cell-therapy-in-pediatric-patients-with-relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia-b-all-and-aggressive-mature-b-cell-non-hodgkin-lymphoma-b-nhl-100529418","NCT06173518","A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)","A Single-Arm, Open-Label, Multicenter, Phase 1b\u002F2 Study Evaluating the Safety and Efficacy of AUTO1 (Obecabtagene Autoleucel [Obe-cel]) in Pediatric Patients With CD19-positive Relapsed\u002FRefractory (R\u002FR) B Cell Acute Lymphoblastic Leukemia (B ALL) or R\u002FR Aggressive Mature B Cell Non-Hodgkin Lymphoma (B NHL).","INCLUSION CRITERIA:\n\n* \\\u003C 18 years old at screening\n* ≥ 6 kg body weight at screening\n\nPediatric patients with r\u002Fr B ALL\n\nr\u002Fr CD19-positive aggressive mature B including the B NHL subtypes: i) diffuse large B cell lymphoma, ii) Burkitt's lymphoma, iii) primary mediastinal large B cell lymphoma, iv) high-grade B cell lymphoma (not otherwise specified).\n\n* Karnofsky (age ≥ 10 years) or Lansky (age \\\u003C 10 year) performance status score ≥ 50%.\n* In participants with B ALL, local documentation of CD19 expression on leukemic blasts in the BM, peripheral blood, or cerebrospinal fluid or biopsy done no more than 30 days prior to consent.\n* Adequate renal, hepatic, pulmonary, and cardiac function.\n\nEXCLUSION CRITERIA:\n\n* Diagnosis of chronic myelogenous leukemia in lymphoid blast crisis.\n* History or presence of clinically relevant central nervous system (CNS) pathology unrelated to CNS leukemia.\n* Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.\n* Received prior (\\\u003C 3 months before obe cel infusion) stem cell transplantation.\n* Prior CD19 targeted therapy other than blinatumomab.\n* Experienced Grade ≥ 3 neurotoxicity following blinatumomab.","0 Years",{"count":87,"type":22},30,[61],"This is a Phase 1b\u002F2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory (r\u002Fr) B cell acute lymphoblastic leukemia (B ALL) and r\u002Fr B cell Non-Hodgkin lymphoma (B NHL).",[91,92],"Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia","Relapsed or Refractory B Cell Non-Hodgkin Lymphoma",[94,95,96,97,98,99,100,101,102,33,103,34],"B cell acute lymphoblastic leukemia","B cell Non-Hodgkin lymphoma","Relapsed B cell acute lymphoblastic leukemia","Relapsed B cell Non-Hodgkin lymphoma","Refractory B cell acute lymphoblastic leukemia","Refractory B cell Non-Hodgkin lymphoma","Aggressive mature B cell Non-Hodgkin lymphoma","Pediatric ALL","Pediatric NHL","CD19-positive CAR T cell","2026-02-26",{"date":106,"type":39},"2026-03-02",{"date":108,"type":39},"2023-11-16",{"date":110,"type":22},"2027-11",{"name":45,"class":46},8,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":132,"locationsCount":133},"100577509","expanded-access-program-for-oos-obe-cel-100577509","NCT06799221","Expanded Access Program for OOS Obe-cel","Expanded Access Program (EAP) for Obecabtagene Autoleucel (Obe-cel) Out-of-specification (OOS) in Adult Patients With Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Patient (or legally authorized representative) is willing to provide informed consent.\n* Patient must be 18 years of age or older.\n* Patient must have a confirmed diagnosis of relapsed\u002Frefractory B cell ALL.\n* Commercial obe-cel was indicated to the patient by their treating physician as per standard of care prior to leukapheresis.\n* The final manufactured obe-cel does not meet the commercial release specifications.\n* The final manufactured obe-cel is acceptable per joint assessment by Autolus and physician taking into account Autolus' release criteria.\n* Remanufacturing (i.e., repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment.\n* Patient deemed medically fit and stable to receive obe-cel infusions per their treating physician's evaluation.\n* For females of childbearing potential (defined as \\\u003C 24 months after last menstruation or not surgically sterile), a negative serum or urine pregnancy test must be documented at screening, prior to lymphodepletion therapy and confirmed before receiving the first dose of study treatment.\n* For females who are not postmenopausal (\\\u003C 24 months of amenorrhea) or who are not surgically sterile (absence of ovaries and\u002For uterus), 2 methods of contraception comprising 1 highly effective method of contraception together with a barrier method must be used during the treatment period and for at least 12 months after the last dose of study treatment. They must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 12 months after receiving the last dose of study drug.\n* For males, it must be agreed that 2 acceptable methods of contraception are used (1 by the patient - usually a barrier method, and 1 highly effective method by the patient's partner) during the treatment period and for at least 12 months after the last dose of study treatment and that sperm will not be donated during the treatment period and for at least 12 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as obe-cel.\n* Pregnant women.\n* Active participation in an interventional trial.","EXPANDED_ACCESS","The purpose of this program is to provide access to obe-cel treatment for adult patients with ALL who have undergone leukapheresis and had obe-cel manufactured from their blood cells but the product is deemed OOS (does not meet the specifications to be used commercially). The target patients for this study have limited options for treatment and repeat blood sampling is not feasible. The main aims of this study are (1) to provide adult patients with ALL with access to obe-cel and (2) to describe the safety profile of obe-cel (including CRS, ICANS, serious infections, secondary cancers, and any side effects) within the first 45 days after infusion of OOS obe-cel.\n\nThis study is a single-arm, open-label, multicenter expanded access program (EAP). The patient population included in this EAP will be adult patients diagnosed with recurring or refractory ALL who were prescribed obe-cel as part of their standard of care and are eligible for use under the approved local prescribing information.\n\nTo be in the study, patients must provide informed consent, be at least 18 years of age, have a confirmed diagnosis of ALL, be medically fit and stable to receive obe-cel, have had commercial obe-cel prescribed by their treating physician as per standard of care, and for whom remanufacturing is not clinically appropriate.\n\nPatients cannot be in the study if they have a history of severe immediate allergic reaction to any drugs or metabolites of similar chemical classes as obe-cel, are a pregnant woman, or are receiving treatment in another study.\n\nAll data will be collected from information routinely recorded in the medical record. There is no formal hypothesis testing. Data will be analyzed descriptively (numbers, percentages and ranges, etc.).",[123,124],"Lymphoblastic Leukemia, Acute, Adult","B Cell ALL",[96,98,126,127,34],"Adult acute lymphoblastic leukemia","Obecabtagene autoleucel (obe-cel)","AVAILABLE","2026-02-25",{"date":131,"type":39},"2026-02-27",{"name":45,"class":46},32,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100541716","phase-1-obe-cel-in-adolescent-applicable-in-uk-only-and-adult-severe-refractory-systemic-lupus-erythematosus-100541716","NCT06333483","Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus","A Single-Arm, Open-Label, Phase I Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients With Severe, Refractory Systemic Lupus Erythematosus","CARLYSLE","Inclusion Criteria:\n\n-Key Inclusion Criteria-\n\n* Women or men ≥ 18 years at screening \\[Spain only\\] or patients 12 to 65 years of age (inclusive) at the time of signing the informed consent \\[UK only\\]\n* Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus\n* Positive for at least one of the following autoantibodies: antinuclear antibodies (ANA) at a titer of ≥ 1:80, or anti-dsDNA (≥ 30 IU\u002FmL) or anti-Smith (\\> upper limit of normal \\[ULN\\]), anti-histone or anti-chromatin (\\> ULN)\n* Severe, refractory SLE\n\nExclusion Criteria:\n\n-Key Exclusion Criteria-\n\n* Medications\n\n  * Within 2 months of leukapheresis: use of anti-CD20 therapy\n  * Prior treatment with anti-CD19 therapy (including bispecifics), adoptive T cell therapy or any prior gene therapy product (e.g., CAR T cell therapy)\n  * Immunization with a live or attenuated vaccine within 2 months of leukapheresis\n* SLE and Autoimmunity:\n\n  * Recurrent neuropsychiatric lupus or active, severe or unstable neuropsychiatric lupus within 2 years from screening\n  * Diagnosis of drug-induced SLE rather than idiopathic SLE\n  * Any acute, severe lupus-related flare during screening that needs immediate treatment and\u002For makes the immunosuppressive washout impossible; thus, making the patient ineligible for CD19 CAR T therapy as judged by the Investigator or Sponsor\n  * Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the patient\n  * Diagnosis of another non-SLE autoimmune disease (e.g., dermatomyositis, polymyositis, scleroderma, rheumatoid arthritis) or overlap syndrome\n* Medical History:\n\n  * History or presence of: (Within 3 months before screening visit)\n\n    * Clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, or stroke\n    * Evidence of deep venous thrombosis or pulmonary embolism\n  * History or presence of severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis\n  * Clinically significant, uncontrolled heart disease not due to SLE (New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled cardiac arrhythmia, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless the patient has a pacemaker) or a recent (within 12 months of screening) cardiac event\n  * Active or uncontrolled fungal, bacterial, viral (including COVID-19), or other infection requiring systemic antimicrobials for management\n  * Active or latent hepatitis B or active hepatitis C\n  * Human immunodeficiency virus, human T-cell leukemia virus (HTLV)-1, HTLV-2 or syphilis positive test at screening\n  * History of malignant neoplasms unless disease free for at least 24 months (basal cell or squamous cell carcinoma in situ, or in situ breast cancer on hormonal therapy allowed)\n  * History of heart, lung, kidney, liver transplant or hematopoietic stem cell transplant\n  * Pregnancy or lactating\n* Laboratory and Organ Function:\n\n  * Left ventricular ejection fraction \\\u003C 45% (or \\\u003C institute's lower limit of normal) confirmed by echocardiogram\n  * Oxygen saturation (SpO2) \\\u003C 90% in the absence of oxygen support\n  * B cell aplasia",{"count":59,"type":22},[61],"This is a Phase 1 study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE.",[146],"Systemic Lupus Erythematosus",[148,127,149,150],"AUTO1","CD19-positive chimeric antigen receptor T cell","CAR-T",{"date":131,"type":39},{"date":153,"type":39},"2024-02-02",{"date":155,"type":22},"2027-09",{"name":45,"class":46},6,""]