[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Allogene Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":108},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100554529","phase-2-consolidation-of-first-line-mrd-remission-with-cema-cel-in-patients-with-lbcl-100554529",false,"NCT06500273","Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL","A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma","ALPHA3","Key Inclusion Criteria:\n\n1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report.\n2. Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy.\n3. Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET\u002FCT evaluation\n4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.\n5. Adult participants ≥18 years of age.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.\n\nKey Exclusion Criteria:\n\n1. LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell\u002Fhistiocyte rich LBCL.\n2. Prior treatment with anti-CD19 targeted therapies.\n3. Anti-cancer treatment, including radiation, after end of treatment PET\u002FCT and\u002For MRD testing is performed.\n4. Active and clinically significant autoimmune disease.\n5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment.\n6. History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.","ALL","18 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.\n\nIn this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide.\n\nPrior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.",[27],"Large B-cell Lymphoma",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51],"Diffuse large B-cell lymphoma","DLBCL","Primary mediastinal B-cell lymphoma","LBCL","High grade B-cell lymphoma","HGBCL","Double-hit lymphoma","High-risk lymphoma","Minimal Residual Disease","MRD","CAR T","Allogeneic CAR T","CD19","cema-cel","cemacabtagene ansegedleucel","PMBCL","Consolidation","First-line","Front-line","Frontline","PhasED-Seq™","CLARITY™","AlloCAR T™","RECRUITING","2026-06-26",{"date":55,"type":56},"2026-06-29","ACTUAL",{"date":58,"type":56},"2024-06-18",{"date":60,"type":21},"2032-12",{"name":62,"class":63},"Allogene Therapeutics","INDUSTRY",77,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100599485","phase-1-a-study-to-investigate-the-safety-and-preliminary-efficacy-of-allo-329-an-allogeneic-car-t-cell-therapy-in-adults-with-autoimmune-disease-100599485","NCT07085104","A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease","A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of ALLO-329, a Dual Anti-CD19\u002FAnti-CD70 Allogeneic CAR T Cell Product in Autoimmune Disease","RESOLUTION","Inclusion Criteria:\n\n1. Adults ≥ 18 to \\\u003C 70 years of age.\n2. Adequate hematological function and liver, cardiac, and pulmonary function.\n3. A highly sensitive urine pregnancy test or serum pregnancy test (for females of childbearing potential) negative at screening. All participants of childbearing potential must be willing to use a highly effective method of contraception for at least 12 months (6 months for males) after LD chemotherapy or ALLO-329 administration, whichever is later.\n4. Signed and dated informed consent form.\n5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.\n6. Confirmed active disease (SLE, IIM, or SSc) as defined by the appropriate classification criteria for each respective disease, clinical evidence, and\u002For laboratory testing.\n7. Disease activity as above despite prior treatment with standard of care therapy including at least one immunosuppressive agent for at least 3 months (in addition to hydroxychloroquine \\[HCQ\\]).\n\nExclusion Criteria:\n\n1. Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection.\n2. Any active malignancy within 5 years prior to enrollment, except for adequately treated localized basal cell or squamous cell skin cancer, carcinoma in situ or low risk prostate cancer (Gleason score ≤ 6).\n3. Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy).\n4. Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes) not due to SLE\u002FIIM\u002FSSc.\n5. Symptomatic cardiac or vascular disease requiring medical intervention within 6 months prior to screening, hemodynamically symptomatic pericardial effusion, or symptomatic electrocardiogram abnormality requiring medical intervention.\n6. Child-Pugh Class B or C cirrhosis.\n7. Symptomatic airway disease requiring medical intervention, pleural effusion ≥ Grade 2, or history of pulmonary embolism requiring anticoagulant therapy within 6 months of enrollment.\n8. Participants known to be refractory to platelet or red blood cell transfusions or who will refuse indicated transfusion support to manage cell counts following treatment.\n9. Any form of primary, inherited immunodeficiency.\n10. Unwilling to participate in an extended safety monitoring period.\n11. For participants with SLE: Active disease involving CNS within the last 6 months or SLE that is drug-induced. For those with lupus nephritis, history of dialysis within 12 months or expected need for renal replacement therapy within the next 12 months, or National Institutes of Health (NIH) chronicity score of 3+ in any of the following domains: glomerular sclerosis, glomerular fibrous crescents, tubular atrophy, and\u002For interstitial fibrosis.\n12. Participants with IIM: A myositis other than IIM classification, non-reversible, unrelated or weakness not amenable to assessment, or dermatomyositis with presence of anti-TIF1 gamma antibody.\n13. Participants with SSc: Pulmonary arterial hypertension requiring treatment, rapidly progressive or severe SSc gastrointestinal involvement, or prior scleroderma renal crisis.","69 Years",{"count":75,"type":21},66,[77],"PHASE1","This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).",[80,81,82],"Systemic Lupus Erythematosus (With and Without Nephritis)","Idiopathic Inflammatory Myopathy","Systemic Sclerosis",[84,85,86,87,88,89,90,91,92,93,94,95,96,39,40,41,97,98],"Systemic lupus erythematosus","SLE","Lupus nephritis","LN","Idiopathic inflammatory myopathy","IIM","Myositis","Dermatomyositis","Anti-synthetase syndrome","Systemic sclerosis","Scleroderma","SSc","Autoimmune disease","CD70","AlloCAR T","2026-06-17",{"date":101,"type":56},"2026-06-18",{"date":103,"type":56},"2025-11-13",{"date":105,"type":21},"2032-10",{"name":62,"class":63},14,""]