[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07488923":3,"trial-entities:NCT07488923":165,"trial-summary:NCT07488923":173},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":40,"secondary_outcomes":45,"sex":56,"minimum_age":57,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":58,"std_ages":86,"locations":89,"central_contacts":156,"overall_officials":162,"references":163,"see_also_links":164},"NCT07488923","ML261-101","A First-in-human (FIH), Phase 1 Study of ML261, an Autologous Potency Enhanced Anti-DLL3 CAR T Cell Therapy, in Participants With R\u002FR SCLC or Select NECs (SPECTRAL-1)","A Phase 1 First-In-Human Study to Investigate the Safety, Pharmacokinetics and Preliminary Efficacy of ML261, an Autologous Anti-DLL3 CAR + CARD11-PIK3R3 Fusion T Cell Therapy, in Participants With Relapsed\u002FRefractory Small Cell Lung Cancer or Select Neuroendocrine Carcinomas","RECRUITING","2030-08","2026-08","2026-08-25","2026-06-23","Moonlight Bio, Inc","INDUSTRY",false,"This is a first-in-human (FIH), open-label, Phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and preliminary efficacy of ML261, an autologous potency enhanced anti-DLL3 CAR T cell therapy, in participants with R\u002FR SCLC or select NECs",null,[19,20,21,22],"Small Cell Lung Cancer (SCLC )","Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)","Gastroenteropancreatic NEC (GEP NEC)","Neuroendocrine Prostate Cancer (NEPC)",[24,25,26],"Neuroendocrine carcinoma","DLL3","CAR T","INTERVENTIONAL","TREATMENT",[30],"PHASE1",{"count":32,"type":33},110,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BIOLOGICAL","ML261","DLL3 directed autologous Chimeric Antigen Receptor T cells",[37],[41],{"measure":42,"description":43,"timeFrame":44},"Incidence of dose-limiting toxicities (DLTs) listed during the DLT observation period","Graded according to Common Terminology Criteria for Adverse Events (CTCAE) or American Society for Transplantation and Cell Therapy (ASTCT) criteria","28 days",[46,50,53],{"measure":47,"description":48,"timeFrame":49},"Incidence of treatment-emergent AEs (TEAEs), Grade ≥3 TEAEs, serious AEs (SAEs), and AEs of special interest (AESIs). Clinically significant laboratory abnormalities \u002F changes from baseline in safety laboratory test results","Graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) or American Society for Transplantation and Cell Therapy (ASTCT) criteria (for grading CRS and ICANS)","Through study completion; up to 2 years",{"measure":51,"description":52,"timeFrame":49},"Characterize the molecular pharmacokinetic (PK) profile of ML261 after dosing","Measurement of ML261 associated vector copy number (VCN) in peripheral blood over time",{"measure":54,"description":55,"timeFrame":49},"Evaluate the preliminary efficacy of ML261 after dosing","Measured by Response Evaluation Criteria In Solid Tumors (RECIST v1.1)","ALL","18 Years",{"inclusion":59,"exclusion":67,"raw_text":85},[60,61,62,63,64,65,66],"≥18 years of age at the time of signing the ICF","Have been previously treated with at least one line of systemic standard of care (SOC) anti-cancer therapy for their respective cancer indication. Participants with locally advanced disease who are eligible for curative resection will be excluded.","Have documented radiological disease progression\u002Frelapse during or after their most recent line of anti-cancer therapy with measurable disease on imaging, as assessed by RECIST v1.1","Have histologically and\u002For cytologically confirmed diagnosis of select advanced or metastatic R\u002FR solid tumor malignancy in one of the following: R\u002FR SCLC, R\u002FR GEP-NEC, R\u002FR high-grade NEPC, R\u002FR epNEC with biopsy-documented DLL3 expression on archival tissue or fresh biopsy by local or central assessment. CNS NEC is excluded. Participants with mixed histologies for any of these indications qualify if the small cell\u002Fneuroendocrine tumor cell percentage is \\> 50%, except for high-grade NEPC where neuroendocrine component must be \\> 20%.","Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 0 or 1","Life expectancy ≥12 weeks","Have adequate hematologic and end-organ function",[68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84],"Previous systemic anti-cancer therapies within the timeframes, as specified in the protocol.","Prior exposure\u002Ftreatment with DLL3-targeted CAR T therapy or any other genetically engineered adoptive T cell therapy.","Prior allogeneic organ transplant (including allogeneic bone marrow transplant).","Major surgical procedure within 4 weeks of the first dose of any study drug administration or anticipated to be in need of a major surgical procedure during the course of study.","Participants with toxicities (as a result of prior anti-cancer therapy) which have not recovered to baseline or CTCAE v5.0 \\\u003CGrade 2, except for adverse events (AEs) not considered a likely safety risk: (e.g., alopecia, neuropathy, non-clinically relevant laboratory abnormalities).","Symptomatic ascites or effusions (pleural or pericardial) requiring intermittent drainage.","History of any other malignancy known to be active, with the exception of completely removed in situ cervical intra-epithelial neoplasia, non-melanoma skin cancer, ductal carcinoma in situ, early-stage prostate cancer that has been adequately treated, and other cancers from which the participant has been disease free for 3 years or longer or does not require treatment and in the opinion of investigator after discussion with the medical monitor are not likely to impact the patient's life expectancy.","One or more of the following cardiac criteria: Unstable angina, Myocardial infarction within 6 months prior to Screening, New York Heart Association Class III to IV heart failure, clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block or third-degree heart block)","Acute venous thromboembolism (VTE). VTEs without hemodynamic compromise, treated with stable doses of anticoagulants are allowed.","Presence of clinically significant CNS pathology:","seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, or cerebellar disease. History of these disorders requires discussion with the medical monitor.","Presence of clinically active psychosis.","Known brain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the first dose of any study drug administration.","Active systemic autoimmune disease or any other condition that requires, or is anticipated to require, systemic treatment with steroids or other systemic immunosuppressive agents, or participants who have received such agents within 4 weeks of leukapheresis and ML261 administration (further details provided in protocol body).","Evidence of interstitial lung disease (such as idiopathic pulmonary fibrosis) or active pneumonitis of any etiology requiring treatment.","Any active infection (defined as symptoms, signs, or radiographic) of bacterial, viral, or fungal or unknown etiology requiring systemic therapy within 14 days of leukapheresis. Participants with clinical and\u002For laboratory evidence of persistent infection will be excluded.","Uncontrolled medical, psychological\u002Fpsychiatric, or social condition that would interfere with the participant's participation or compromise the objectives of the study in the opinion of the Investigator and\u002For the Sponsor.","Inclusion Criteria\n\n* ≥18 years of age at the time of signing the ICF\n* Have been previously treated with at least one line of systemic standard of care (SOC) anti-cancer therapy for their respective cancer indication. Participants with locally advanced disease who are eligible for curative resection will be excluded.\n* Have documented radiological disease progression\u002Frelapse during or after their most recent line of anti-cancer therapy with measurable disease on imaging, as assessed by RECIST v1.1\n* Have histologically and\u002For cytologically confirmed diagnosis of select advanced or metastatic R\u002FR solid tumor malignancy in one of the following: R\u002FR SCLC, R\u002FR GEP-NEC, R\u002FR high-grade NEPC, R\u002FR epNEC with biopsy-documented DLL3 expression on archival tissue or fresh biopsy by local or central assessment. CNS NEC is excluded. Participants with mixed histologies for any of these indications qualify if the small cell\u002Fneuroendocrine tumor cell percentage is \\> 50%, except for high-grade NEPC where neuroendocrine component must be \\> 20%.\n* Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 0 or 1\n* Life expectancy ≥12 weeks\n* Have adequate hematologic and end-organ function\n\nExclusion Criteria:\n\n* Previous systemic anti-cancer therapies within the timeframes, as specified in the protocol.\n* Prior exposure\u002Ftreatment with DLL3-targeted CAR T therapy or any other genetically engineered adoptive T cell therapy.\n* Prior allogeneic organ transplant (including allogeneic bone marrow transplant).\n* Major surgical procedure within 4 weeks of the first dose of any study drug administration or anticipated to be in need of a major surgical procedure during the course of study.\n* Participants with toxicities (as a result of prior anti-cancer therapy) which have not recovered to baseline or CTCAE v5.0 \\\u003CGrade 2, except for adverse events (AEs) not considered a likely safety risk: (e.g., alopecia, neuropathy, non-clinically relevant laboratory abnormalities).\n* Symptomatic ascites or effusions (pleural or pericardial) requiring intermittent drainage.\n* History of any other malignancy known to be active, with the exception of completely removed in situ cervical intra-epithelial neoplasia, non-melanoma skin cancer, ductal carcinoma in situ, early-stage prostate cancer that has been adequately treated, and other cancers from which the participant has been disease free for 3 years or longer or does not require treatment and in the opinion of investigator after discussion with the medical monitor are not likely to impact the patient's life expectancy.\n* One or more of the following cardiac criteria: Unstable angina, Myocardial infarction within 6 months prior to Screening, New York Heart Association Class III to IV heart failure, clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block or third-degree heart block)\n* Acute venous thromboembolism (VTE). VTEs without hemodynamic compromise, treated with stable doses of anticoagulants are allowed.\n* Presence of clinically significant CNS pathology:\n\n  * seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, or cerebellar disease. History of these disorders requires discussion with the medical monitor.\n  * Presence of clinically active psychosis.\n  * Known brain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the first dose of any study drug administration.\n* Active systemic autoimmune disease or any other condition that requires, or is anticipated to require, systemic treatment with steroids or other systemic immunosuppressive agents, or participants who have received such agents within 4 weeks of leukapheresis and ML261 administration (further details provided in protocol body).\n* Evidence of interstitial lung disease (such as idiopathic pulmonary fibrosis) or active pneumonitis of any etiology requiring treatment.\n* Any active infection (defined as symptoms, signs, or radiographic) of bacterial, viral, or fungal or unknown etiology requiring systemic therapy within 14 days of leukapheresis. Participants with clinical and\u002For laboratory evidence of persistent infection will be excluded.\n* Uncontrolled medical, psychological\u002Fpsychiatric, or social condition that would interfere with the participant's participation or compromise the objectives of the study in the opinion of the Investigator and\u002For the Sponsor.",[87,88],"ADULT","OLDER_ADULT",[90,103,114,124,135,146],{"facility":91,"status":8,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":100},"Washington University Medicine","St Louis","Missouri","63130","United States",[97],{"name":98,"role":99},"Jeff Ward, MD","PRINCIPAL_INVESTIGATOR",{"lat":101,"lon":102},38.62727,-90.19789,{"facility":104,"status":8,"city":105,"state":106,"zip":107,"country":95,"contacts":108,"geoPoint":111},"Hackensack University Medical Center","Hackensack","New Jersey","07601",[109],{"name":110,"role":99},"Martin Gutierrez, MD",{"lat":112,"lon":113},40.88593,-74.04347,{"facility":115,"status":8,"city":116,"state":116,"zip":117,"country":95,"contacts":118,"geoPoint":121},"NYU Langone Health","New York","10016",[119],{"name":120,"role":99},"Salman Punekar, MD",{"lat":122,"lon":123},40.71427,-74.00597,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":95,"contacts":129,"geoPoint":132},"Sarah Cannon Research Institute (SCRI)","Nashville","Tennessee","37203",[130],{"name":131,"role":99},"Melissa Johnson, MD",{"lat":133,"lon":134},36.16589,-86.78444,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":95,"contacts":140,"geoPoint":143},"UT Southwestern Medical Center","Dallas","Texas","75235",[141],{"name":142,"role":99},"Ben Drapkin, MD",{"lat":144,"lon":145},32.78306,-96.80667,{"facility":147,"status":8,"city":148,"state":138,"zip":149,"country":95,"contacts":150,"geoPoint":153},"MD Anderson Cancer Center","Houston","77030",[151],{"name":152,"role":99},"Ecaterina Dumbrava, MD",{"lat":154,"lon":155},29.76328,-95.36327,[157],{"name":158,"role":159,"phone":160,"email":161},"Moonlight Bio Clinical Team","CONTACT","206-647-6168","MLTrials@moonlightbio.us",[],[],[],{"nct_id":4,"conditions":166,"biomarkers":172},[167,168,169,170,171],"Extrapulmonary Neuroendocrine Carcinoma","Gastroenteropancreatic Neuroendocrine Carcinoma","Lung Small Cell Carcinoma","Prostate Neuroendocrine Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":174,"summary":175,"prompt_version":185},true,{"design":176,"status":177,"heading":178,"summary":179,"follow_up":180,"word_count":181,"commitments":182,"compensation":183,"drugs_mentioned":184},"This is a first-in-human, open-label, Phase 1 study planning to enroll 110 participants. It is designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ML261.","completed","Phase 1 Study of ML261 for SCLC or Select NECs","This is a first-in-human Phase 1 study testing a new cell therapy called ML261. ML261 is a type of CAR T cell therapy, which uses your own immune cells to fight cancer. This study is for people with small cell lung cancer (SCLC) or certain neuroendocrine cancers (NECs) that have come back or not responded to previous treatments. The main goal is to see how safe ML261 is and to find the right dose. Researchers will also look at how the treatment moves through your body and if it shows any early signs of working against the cancer. You must be at least 18 years old and have already received at least one standard cancer treatment.","The primary endpoint measures dose-limiting toxicities during a 28-day observation period.",116,"Not specified in the trial record.","Not stated in the trial record.",[37],"v2"]