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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
Completion Date
2046-04
Last Updated
2026-04-22
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 (2)
City of Hope
Duarte, California, United States
Tennessee Oncology
Nashville, Tennessee, United States