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

Part of paid clinical trials in Duarte, California.

Sponsor
Dispatch Biotherapeutics
Study ID
NCT07544589
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Colorectal Cancer
  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
  • Gastroesophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DISP-10 — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Apr 30, 2046
Completion
Apr 30, 2046

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DISP-10
    Participants will receive DV-10 in combination with ide-cel. Lymphodepleting chemotherapy (fludarabine and cyclophosphamide) will be administered a few days prior to ide-cel.

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 90 days (2 years for related Serious Adverse Events) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of Cincinnati Cancer CenterCincinnatiOhio45267-
Tennessee OncologyNashvilleTennessee37203-

Find similar trials in Duarte, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
City of Hope· Duarte, CAUniversity of Cincinnati Cancer Center· Cincinnati, OHTennessee Oncology· Nashville, TN

Related Studies