[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07544589":3,"trial-entities:NCT07544589":150,"trial-summary:NCT07544589":155},{"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":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":43,"secondary_outcomes":58,"sex":90,"minimum_age":91,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":92,"std_ages":96,"locations":99,"central_contacts":141,"overall_officials":147,"references":148,"see_also_links":149},"NCT07544589","DISP-10-101","A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers","A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers","RECRUITING","2046-04","2026-08","2026-08-27","2026-04-13","Dispatch Biotherapeutics","INDUSTRY",false,"This is a Phase 1, multicenter, open-label study of DISP-10, a combination therapy consisting of DV-10 (adenovirus) and idecabtagene vicleucel (ide-cel, BCMA-directed chimeric antigen receptor \\[CAR\\] T), in adult participants with advanced gastrointestinal (GI) cancers.\n\nThe study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). Part 1 of the study will evaluate the safety and tolerability of increasing dose levels of DISP-10 to establish the recommended dose for expansion (RDE); Part 2 will evaluate the safety and efficacy of DISP-10 in participants treated at the RDE.",null,[19,20,21,22],"Colorectal Cancer","Gastric Adenocarcinoma","Esophageal Adenocarcinoma","Gastroesophageal Adenocarcinoma",[24,25,26,27,28,29],"CAR T","Adenovirus","ABECMA","BCMA","gastrointestinal cancer","CAR-T","INTERVENTIONAL","TREATMENT",[33],"PHASE1",{"count":35,"type":36},66,"ESTIMATED",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42},"BIOLOGICAL","DISP-10","Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce ide-cel.\n\nDuring ide-cel production, participants may receive bridging therapy for disease control per Investigator discretion.\n\nDV-10 administration will be followed by lymphodepleting chemotherapy (fludarabine and cyclophosphamide) and subsequent ide-cel administration.",[40],[44,48,51,55],{"measure":45,"description":46,"timeFrame":47},"Incidence of Treatment Emergent Adverse Events (TEAEs)","Graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v6.0","90 days (2 years for related Serious Adverse Events)",{"measure":49,"description":46,"timeFrame":50},"Incidence of Dose Limiting Toxicities (DLTs) [PART 1]","28 days",{"measure":52,"description":53,"timeFrame":54},"Identification of the Recommended Dose for Expansion (RDE) [PART 1]","To select the Recommended Dose for Expansion (RDE) for Part 2","Up to 2 years",{"measure":56,"description":57,"timeFrame":54},"Overall response rate (ORR) [PART 2]","Confirmed complete response (CR) or partial response (PR), per RECIST v1.1",[59,62,65,68,71,75,78,81,84,87],{"measure":60,"description":61,"timeFrame":54},"Overall response rate (ORR) [PART 1]","Confirmed CR or PR, per RECIST v1.1",{"measure":63,"description":64,"timeFrame":54},"Disease control rate (DCR)","Proportion of participants with CR, PR, or stable disease per RECIST v1.1",{"measure":66,"description":67,"timeFrame":54},"Duration of response (DOR)","Time from CR or PR to radiographic progression or death",{"measure":69,"description":70,"timeFrame":54},"Progression Free Survival (PFS)","Time from ide-cel administration to disease progression or death, whichever occurs first",{"measure":72,"description":73,"timeFrame":74},"Overall survival (OS)","Time from ide-cel administration to death","Up to 15 years",{"measure":76,"description":77,"timeFrame":54},"Time to response (TTR)","Time from ide-cel administration to the first documentation of objective tumor response",{"measure":79,"description":80,"timeFrame":54},"Cellular kinetics (CK) of ide-cel","Measurement of ide-cel CK in the blood",{"measure":82,"description":83,"timeFrame":54},"Pharmacokinetics of DV-10 - Cmax","Maximum concentration in blood",{"measure":85,"description":86,"timeFrame":54},"Pharmacokinetics of DV-10 - Tmax","Time to maximum concentration in blood",{"measure":88,"description":89,"timeFrame":54},"Pharmacokinetics of DV-10 - AUC","Area under the blood concentration curve","ALL","18 Years",{"inclusion":93,"exclusion":94,"raw_text":95},[],[],"Key Inclusion Criteria:\n\n1. Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, or colorectal adenocarcinoma\n2. Measurable disease according to RECIST v1.1 and at least 1 additional site of disease amenable to biopsy\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n4. Aged ≥18 years at time of signing informed consent\n5. Adequate organ function\n\nKey Exclusion Criteria:\n\n1. Previous solid organ or hematopoietic cell transplant\n2. Evidence of rapid disease progression, defined as radiographic or clinical progression within 3 months of the most recent prior line of therapy\n3. Known history of hepatitis B or HIV infection\n4. Previous or concurrent malignancy except if curatively treated more than 3 years prior to enrollment\n5. Known active central nervous system (CNS) metastases\n6. Clinically significant pleural or pericardial effusion or peritoneal carcinomatosis\n7. Active treatment with antiviral agents\n8. History of severe hypersensitivity to fludarabine or cyclophosphamide\n9. Prior therapies\u002Ftreatments with oncolytic viruses or T cell derived cellular therapy",[97,98],"ADULT","OLDER_ADULT",[100,109,116,124,132],{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":105,"geoPoint":106},"City of Hope","Duarte","California","91010","United States",{"lat":107,"lon":108},34.13945,-117.97729,{"facility":110,"status":8,"city":111,"state":103,"zip":112,"country":105,"geoPoint":113},"Hoag Memorial Hospital Presbyterian","Newport Beach","92663",{"lat":114,"lon":115},33.61891,-117.92895,{"facility":117,"status":8,"city":118,"state":119,"zip":120,"country":105,"geoPoint":121},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",{"lat":122,"lon":123},42.35843,-71.05977,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":105,"geoPoint":129},"University of Cincinnati Cancer Center","Cincinnati","Ohio","45267",{"lat":130,"lon":131},39.12711,-84.51439,{"facility":133,"status":134,"city":135,"state":136,"zip":137,"country":105,"geoPoint":138},"Tennessee Oncology","NOT_YET_RECRUITING","Nashville","Tennessee","37203",{"lat":139,"lon":140},36.16589,-86.78444,[142],{"name":143,"role":144,"phone":145,"email":146},"Dispatch Clinical","CONTACT","(215) 792-4699","clinicaltrials@dispatchbio.com",[],[],[],{"nct_id":4,"conditions":151,"biomarkers":154},[152,21,20,153],"Colorectal Carcinoma","Malignant Digestive System Neoplasm",[],{"nct_id":4,"found":156,"summary":157,"prompt_version":167},true,{"design":158,"status":159,"heading":160,"summary":161,"follow_up":162,"word_count":163,"commitments":164,"compensation":165,"drugs_mentioned":166},"This is a Phase 1, open-label study, meaning both you and your doctors will know what treatment you are receiving. It will involve about 66 participants and has two parts: one to find the right dose and another to further test safety and effectiveness.","completed","Phase 1 Study of DISP-10 for Advanced Gastrointestinal Cancers","This study is testing a new combination treatment called DISP-10 for people with advanced gastrointestinal (GI) cancers, including colorectal, gastric, and esophageal adenocarcinoma. DISP-10 combines DV-10 (an adenovirus) with ide-cel (a type of CAR T-cell therapy). To get ide-cel, your own white blood cells will be collected. The main goal of this first phase of the study is to find the safest and most effective dose of DISP-10. Researchers will be looking closely at any side effects and how well participants tolerate the treatment. You may be able to join if you have one of these advanced GI cancers, measurable disease, and a good performance status. The study plans to enroll 66 participants.","Researchers will track treatment-related side effects for up to 90 days, and serious side effects for up to 2 years. The recommended dose will be identified within 2 years.",113,"Participants will undergo leukapheresis (a procedure to collect blood cells) to create the ide-cel treatment. The study record does not provide details on the number of visits or other specific procedures.","Not stated in the trial record.",[40],"v2"]