[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07439653":3,"trial-entities:NCT07439653":150,"trial-summary:NCT07439653":159},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":46,"secondary_outcomes":63,"sex":95,"minimum_age":96,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":97,"std_ages":113,"locations":116,"central_contacts":141,"overall_officials":147,"references":148,"see_also_links":149},"NCT07439653","TORL5700-001","A Study of TORL-5-700 in Relapsed\u002FRefractory Non Hodgkin's Lymphoma","A Phase 1\u002F2, First-in-Human, Open-Label, Multicenter Study of TORL-5-700 as a Monotherapy and in Combination for Participants With Relapsed or Refractory Non-Hodgkin Lymphoma","RECRUITING","2029-09-30","2026-06","2026-06-11","2026-03-31","TORL Biotherapeutics, LLC","INDUSTRY",false,"A Phase 1\u002F2 study to evaluate safety, tolerability, and anticancer activity of TORL-5-700 as a monotherapy and in combination in R\u002FR NHL",null,[19],"Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},155,"ESTIMATED",[30,36,41],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","TORL-5-700","Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks",[35],"Part 1: Monotherapy Dose Escalation",{"type":31,"name":37,"description":38,"armGroupLabels":39},"TORL-5-700 at MTD\u002FRP2D","Part 2: Monotherapy Expansion - TORL-5-700 at Maximum tolerated Dose (MTD)\u002FRecommended Phase 2 Dose (RP2D) Administered once every three weeks",[40],"Part 2: Monotherapy Expansion",{"type":31,"name":42,"description":43,"armGroupLabels":44},"TORL-5-700 at MTD\u002FRP2D in combination with another agent","Part 3: Combination Evaluation - TORL-5-700 at MTD\u002FRP2D administered every three weeks in combination with another agent",[45],"Part 3: Combination Evaluation",[47,51,54,56,60],{"measure":48,"description":49,"timeFrame":50},"Evaluate the safety of TORL-5-700 as a monotherapy","Assessment of adverse events according to NCI-CTCAE Version 5.0","though study completion, an average of 2.5 years",{"measure":52,"description":53,"timeFrame":50},"Assess the antitumor activity of TORL-5-700 as monotherapy","Assess the antitumor activity of TORL-5-700 using Cheson (2014) disease grading criteria",{"measure":55,"description":49,"timeFrame":50},"Evaluate the safety of TORL-5-700 in combination with other agents",{"measure":57,"description":58,"timeFrame":59},"Determine the Maximum Tolerated Dose (MTD)","Determine the MTD by assessing Protocol defined Dose Limiting Toxicities (DLT)","21 days from the start of treatment",{"measure":61,"description":62,"timeFrame":59},"Determine the Recommended Phase 2 Dose (RP2D)","Determine the RP2D by assessing Protocol defined Dose Limiting Toxicities",[64,68,70,72,74,76,78,80,82,85,87,90,92],{"measure":65,"description":66,"timeFrame":67},"Maximum Serum Concentration of TORL-5-700 (Cmax)","Pk assessment","though end of study treatment, an average of 5 months",{"measure":69,"description":66,"timeFrame":67},"Maximum Serum Concentration of TORL-5-700 (Cmax) in combination with other agents",{"measure":71,"description":66,"timeFrame":67},"Terminal Half-life (t1\u002F2) of Serum TORL-5-700",{"measure":73,"description":66,"timeFrame":67},"Terminal Half-life (t1\u002F2) of Serum TORL-5-700 in combination with other agents",{"measure":75,"description":66,"timeFrame":67},"Area under the Serum Concentration -Time curve for TORL-5-700 from the time of dosing to the last measurable concentration",{"measure":77,"description":66,"timeFrame":67},"Area under the Serum Concentration -Time curve for TORL-5-700 from the time of dosing to the last measurable concentration in combination with other agents",{"measure":79,"description":66,"timeFrame":67},"Clearance (CL) of TORL-5-700",{"measure":81,"description":66,"timeFrame":67},"Clearance (CL) of TORL-5-700 in combination with other agents",{"measure":83,"description":84,"timeFrame":67},"Volume of distribution of TORL-5-700","PK assessment",{"measure":86,"description":84,"timeFrame":67},"Volume of distribution of TORL-5-700 in combination with other agents",{"measure":88,"description":89,"timeFrame":67},"Immunogenicity of TORL-5-700","Immunogenicity will be measured by incidence of treatment emergent ADAs",{"measure":91,"description":89,"timeFrame":67},"Immunogenicity of TORL-5-700 in combination with other agents",{"measure":93,"description":94,"timeFrame":50},"Assess the preliminary antitumor activity of TORL-5-700 in combination with other agents","Assess the antitumor activity of TORL-5-700 in combination with other agents using Cheson (2014) disease grading criteria","ALL","18 Years",{"inclusion":98,"exclusion":104,"raw_text":112},[99,100,101,102,103],"Confirmed B-NHL, including but not limited to de novo DLBCL; FL, Grades 1 to 3A; MCL; transformed lymphoma (tFL, RT) and FL Grade 3B; MZL and MALT.","Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.","At least 1 measurable lesion per Lugano criteria.","Tumor tissue is available.","Adequate organ function",[105,106,107,108,109,110,111],"T-cell lymphoma","CLL or SL","Burkitt lymphoma and high-grade B-cell lymphoma","CNS involvement","Peripheral neuropathy \\> Grade 2","Uncontrolled medical conditions","Viral infections","Inclusion Criteria:\n\n* Confirmed B-NHL, including but not limited to de novo DLBCL; FL, Grades 1 to 3A; MCL; transformed lymphoma (tFL, RT) and FL Grade 3B; MZL and MALT.\n* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.\n* At least 1 measurable lesion per Lugano criteria.\n* Tumor tissue is available.\n* Adequate organ function\n\nExclusion Criteria:\n\n* T-cell lymphoma\n* CLL or SL\n* Burkitt lymphoma and high-grade B-cell lymphoma\n* CNS involvement\n* Peripheral neuropathy \\> Grade 2\n* Uncontrolled medical conditions\n* Viral infections",[114,115],"ADULT","OLDER_ADULT",[117,126,133],{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":122,"geoPoint":123},"UCLA","Santa Monica","California","90404","United States",{"lat":124,"lon":125},34.01949,-118.49138,{"facility":127,"status":8,"city":128,"state":120,"zip":129,"country":122,"geoPoint":130},"Stanford University","Stanford","94305",{"lat":131,"lon":132},37.42411,-122.16608,{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":122,"geoPoint":138},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",{"lat":139,"lon":140},36.16589,-86.78444,[142],{"name":143,"role":144,"phone":145,"email":146},"Timothy Welliver, M.D.","CONTACT","(310) 598-5969","timothy.welliver@torlbio.com",[],[],[],{"nct_id":4,"conditions":151,"biomarkers":158},[152,153,154,155,156,157],"Diffuse Large B-Cell Lymphoma","Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Follicular Lymphoma","Mantle Cell Lymphoma","Marginal Zone Lymphoma","Non-Hodgkin Lymphoma",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]