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RECRUITING
NCT07544589
PHASE1

A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers

Sponsor: Dispatch Biotherapeutics

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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