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A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
Sponsor: Dispatch Biotherapeutics
Summary
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. The 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.
Official title: A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2026-04-13
Completion Date
2046-04
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
DISP-10
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce ide-cel. During ide-cel production, participants may receive bridging therapy for disease control per Investigator discretion. DV-10 administration will be followed by lymphodepleting chemotherapy (fludarabine and cyclophosphamide) and subsequent ide-cel administration.
Locations (7)
City of Hope
Duarte, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States
Tennessee Oncology
Nashville, Tennessee, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States