[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07586618":3,"trial-entities:NCT07586618":187,"trial-summary:NCT07586618":191},{"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":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":47,"sex":86,"minimum_age":87,"maximum_age":17,"healthy_volunteers":88,"eligibility_criteria":89,"std_ages":93,"locations":96,"central_contacts":172,"overall_officials":181,"references":185,"see_also_links":186},"NCT07586618","The ALLiance Study","First-in-human Study of a New Treatment (4A10) for Patients With Relapsed or Hard-to-treat Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma, Focused on Safety and How the Drug Behaves in the Body and Early Signs of Effect.","A First in Human, Phase 1, Open-Label Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 4A10 Monotherapy In Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","RECRUITING","2028-09","2026-07","2026-07-28","2026-06-01","Allterum Therapeutics, Inc","INDUSTRY",true,"ALT-101 is a first-in-human Phase 1 clinical trial testing a new antibody drug called 4A10 in patients with relapsed or hard-to-treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma.\n\n4A10 is a targeted therapy designed to recognize and attach to a specific protein (CD127) found on leukemia cells. Once it binds, it works in two ways: it blocks growth signals that help cancer cells survive, and it helps the immune system find and destroy those cancer cells.\n\nIn this study, patients receive 4A10 through an intravenous (IV) infusion once a week. The main goal of the trial is to find out if the drug is safe, what dose can be given, and how the body processes it. Researchers will also look for early signs that the treatment may be working.\n\nThe study starts with small groups of patients receiving increasing doses to carefully monitor safety. Each patient is closely observed during the first treatment cycle (about 4-6 weeks) to watch for side effects. If the treatment is helping and is well tolerated, patients may continue treatment for up to six cycles.\n\nOverall, this study is an early step in testing a new, targeted immune-based therapy for difficult-to-treat blood cancers.",null,[19,20],"Lymphoblastic Lymphoma","Acute Lymphoblastic Leukemia ALL",[22,23,24],"Leukemia","Refractory","Relapsed","INTERVENTIONAL","TREATMENT",[28],"PHASE1",{"count":30,"type":31},24,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","4A10","4A10 (Molecule B4532) is an investigational human Immunoglobulin G Subclass 1 (IgG1) monoclonal antibody that specifically binds CD127 (Interleukin-7 receptor alpha subunit, IL-7Rα). CD127 is a component of the interleukin-7 receptor and the thymic stromal lymphopoietin receptor (TSLPR), which are expressed on T-cell acute lymphoblastic leukemia (T-ALL) and pre-B-cell acute lymphoblastic leukemia (B-ALL) cells.",[38],"Single Arm",[40,44],{"measure":41,"description":42,"timeFrame":43},"Incidence of Treatment-Emergent Adverse Events (TEAEs) at each dose level","Assessment of safety and tolerability of 4A10 as measured by the incidence, severity, and relationship of treatment-emergent adverse events, as graded by CTCAE v6, in participants receiving study treatment at each dose-level in the 3+3 dose escalation study design.","Through study duration, an average of 1 year",{"measure":45,"description":46,"timeFrame":43},"Determine the Recommended Phase 2 Dose (RP2D)\u002F Recommended Dose for Expansion (RDE) of 4A10 as a single agent in patients with R\u002FR ALL\u002FLL.","Determination of the RP2D\u002FRDE of ALT-101 based on evaluation of safety, tolerability, and available pharmacokinetic and pharmacodynamic data following dose-escalation.",[48,51,54,56,59,62,64,66,69,71,73,75,77,79,82,84],{"measure":49,"description":50,"timeFrame":43},"Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory\u002F relapsed ALL or LL.","Complete Remission (CR) Rate Percentage of participants who achieve Complete Remission (CR) according to standardized disease response criteria.",{"measure":52,"description":53,"timeFrame":43},"Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed\u002FRefractory ALL\u002FLL.","Cmax (Maximum Observed Concentration):\n\nThe highest observed plasma (or serum) concentration of 4A10 following administration. This parameter reflects the peak systemic exposure achieved after dosing.",{"measure":52,"description":55,"timeFrame":43},"Tmax (Time to Maximum Concentration):\n\nThe time elapsed from 4A10 administration to the occurrence of Cmax. This parameter describes the rate of absorption and systemic exposure onset.",{"measure":52,"description":57,"timeFrame":58},"AUC (Area Under the Concentration-Time Curve):\n\nThe integral of the plasma concentration-time curve over a defined time interval (e.g., AUC₀-t and\u002For AUC₀-∞), representing the total systemic exposure to 4A10 over time.","Through the study duration, an average of 1 year.",{"measure":52,"description":60,"timeFrame":61},"T½ (Elimination Half-Life):\n\nThe time required for the plasma concentration of 4A10 to decrease by 50% during the terminal elimination phase. This parameter reflects the rate of systemic drug elimination.","Through the study duration, an average of 1 year",{"measure":52,"description":63,"timeFrame":61},"Vd (Volume of Distribution):\n\nA theoretical volume representing the extent to which 4A10 distributes into tissues relative to plasma. It provides insight into the drug's tissue distribution characteristics.",{"measure":52,"description":65,"timeFrame":61},"CL (Clearance):\n\nThe rate at which 4A10 is removed from systemic circulation, typically expressed as volume per unit time. This parameter reflects the efficiency of drug elimination via metabolic and\u002For excretory pathways.",{"measure":49,"description":67,"timeFrame":68},"Complete Remission With Incomplete Count Recovery (CRi) Rate Percentage of participants who achieve Complete Remission with Incomplete Count Recovery (CRi) according to standardized disease response criteria.","Through study duration, an average of 1 year.",{"measure":49,"description":70,"timeFrame":43},"Measurable Residual Disease (MRD) Negativity Rate Percentage of participants achieving MRD-negative status among participants who achieve CR or CRi.",{"measure":49,"description":72,"timeFrame":43},"Duration of Response (DOR) Time from first documented CR or CRi to disease relapse, progression, or death from any cause, whichever occurs first.",{"measure":49,"description":74,"timeFrame":43},"Time to Response (TTR) Time from initiation of study treatment to first documented achievement of CR or CRi.",{"measure":49,"description":76,"timeFrame":43},"Event-Free Survival (EFS) Time from initiation of study treatment to treatment failure, relapse, or death from any cause.",{"measure":49,"description":78,"timeFrame":61},"Time to Progression (TTP) Time from initiation of study treatment to documented disease progression.",{"measure":80,"description":81,"timeFrame":43},"Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory\u002F relapsed ALL or LL","Overall Survival (OS) Time from initiation of study treatment to death from any cause.",{"measure":80,"description":83,"timeFrame":43},"Rate of Hematopoietic Stem Cell Transplantation (HSCT) Percentage of participants proceeding to hematopoietic stem cell transplantation following study treatment.",{"measure":80,"description":85,"timeFrame":43},"Transfusion Independence Rate Percentage of participants achieving transfusion independence during study treatment and follow-up.","ALL","18 Years",false,{"inclusion":90,"exclusion":91,"raw_text":92},[],[],"Key Inclusion Criteria:\n\n1. Confirmed diagnosis of T\u002FB-ALL or T\u002FB-LL\n2. Relapsed or refractory disease without curative options\n3. Adequate organ function and performance status\n\nKey Exclusion Criteria:\n\n1. Patients with CNS3 disease\n2. Patients with DNA fragility syndromes (e.g., Fanconi, Bloom), trisomy 21 (Down Syndrome)\n3. Prior exposure to anti-CD127 therapies\n4. Uncontrolled infections",[94,95],"ADULT","OLDER_ADULT",[97,113,128,141,160],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"contacts":104,"geoPoint":110},"Children's Hospital Colorado","NOT_YET_RECRUITING","Aurora","Colorado","80045","United States",[105],{"name":106,"role":107,"phone":108,"email":109},"Kelly Faulk, MD","CONTACT","(720)777-6740","Kelly.Faulk@childrenscolorado.org",{"lat":111,"lon":112},39.72943,-104.83192,{"facility":114,"status":8,"city":115,"state":115,"zip":116,"country":103,"contacts":117,"geoPoint":125},"Memorial Sloan Kettering Cancer Center","New York","10065",[118,122],{"name":119,"role":107,"phone":120,"email":121},"Juliette Wiseman Site Contact","855-762-0678","wisemanj@mskcc.org",{"name":123,"role":124},"Maria Luisa Sulis, MD","PRINCIPAL_INVESTIGATOR",{"lat":126,"lon":127},40.71427,-74.00597,{"facility":129,"status":99,"city":130,"state":131,"zip":132,"country":103,"contacts":133,"geoPoint":138},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",[134],{"name":135,"role":107,"phone":136,"email":137},"Susan Rheingold, MD","(267) 426-0762","rheingold@chop.edu",{"lat":139,"lon":140},39.95238,-75.16362,{"facility":142,"status":8,"city":143,"state":144,"zip":145,"country":103,"contacts":146,"geoPoint":157},"Cook Children's Medical Center","Fort Worth","Texas","76104",[147,151,155],{"name":148,"role":107,"phone":149,"email":150},"Heather Jernigan","682-885-2103","Heather.Jernigan@cookchildrens.org",{"name":152,"role":107,"phone":153,"email":154},"Andrea Martinez","682-303-3061","andrea.martinez@cookchildrens.org",{"name":156,"role":124},"Holly Pacenta, MD",{"lat":158,"lon":159},32.72541,-97.32085,{"facility":161,"status":8,"city":162,"state":144,"zip":163,"country":103,"contacts":164,"geoPoint":169},"Texas Children's Hospital","Houston","77030",[165],{"name":166,"role":107,"phone":167,"email":168},"Eric Schafer, MD","(832) 822-3300","esschafe@texaschildrens.org",{"lat":170,"lon":171},29.76328,-95.36327,[173,177],{"name":174,"role":107,"phone":175,"email":176},"Shibani M Kudchadkar, MD","15153439875","skudchadkar@allterum.com",{"name":178,"role":107,"phone":179,"email":180},"Yan Moore, MD, MBA","6178004959","ymoore@allterum.com",[182],{"name":166,"affiliation":183,"role":184},"Baylor College of Medicine","STUDY_CHAIR",[],[],{"nct_id":4,"conditions":188,"biomarkers":190},[189,19],"Acute Lymphoblastic Leukemia",[],{"nct_id":4,"found":15,"summary":192,"prompt_version":202},{"design":193,"status":194,"heading":195,"summary":196,"follow_up":197,"word_count":198,"commitments":199,"compensation":200,"drugs_mentioned":201},"This is an interventional study with a planned enrollment of 24 participants. It is a first-in-human study, meaning it's the first time this drug is being tested in people.","completed","First-in-human Study of 4A10 for Relapsed or Hard-to-Treat ALL or Lymphoblastic Lymphoma","This is a first-in-human clinical trial testing a new antibody drug called 4A10 for patients aged 18 and older with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma that has come back or is hard to treat. 4A10 is a targeted therapy that works by attaching to a specific protein (CD127) on cancer cells, blocking their growth, and helping your immune system fight them. You would receive 4A10 through an IV once a week. The main goals are to see if 4A10 is safe, find the right dose, understand how your body handles it, and look for early signs that it might be working. This study is currently recruiting, with a plan for 24 participants.","Participants will be followed for an average of 1 year to monitor for side effects and determine the recommended dose.",114,"You would receive 4A10 through an intravenous (IV) infusion once a week. The study duration is an average of 1 year.","Not stated in the trial record.",[35],"v2"]