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NOT YET 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

Completion Date

2046-04

Last Updated

2026-04-22

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 (2)

City of Hope

Duarte, California, United States

Tennessee Oncology

Nashville, Tennessee, United States