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

NCT07544589 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DISP-10-101
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Colorectal Cancer; Gastric Adenocarcinoma; Esophageal Adenocarcinoma; Gastroesophageal Adenocarcinoma

Keywords

CAR T; Adenovirus; ABECMA; BCMA; gastrointestinal cancer; CAR-T

Outcome Measures

Primary Outcomes (4)

• Incidence of Treatment Emergent Adverse Events (TEAEs)

  Graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v6.0

  90 days (2 years for related Serious Adverse Events)

• Incidence of Dose Limiting Toxicities (DLTs) [PART 1]

  Graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v6.0

  28 days

• Identification of the Recommended Dose for Expansion (RDE) [PART 1]

  To select the Recommended Dose for Expansion (RDE) for Part 2

  Up to 2 years

• Overall response rate (ORR) [PART 2]

  Confirmed complete response (CR) or partial response (PR), per RECIST v1.1

  Up to 2 years

Secondary Outcomes (10)

• Overall response rate (ORR) [PART 1]

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DOR)

  Up to 2 years

• Progression Free Survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 15 years

Study Arms (1)

DISP-10

EXPERIMENTAL

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.

Biological: DISP-10

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.

DISP-10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, or colorectal adenocarcinoma
• Measurable disease according to RECIST v1.1 and at least 1 additional site of disease amenable to biopsy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Aged ≥18 years at time of signing informed consent
• Adequate organ function

You may not qualify if:

• Previous solid organ or hematopoietic cell transplant
• Evidence of rapid disease progression, defined as radiographic or clinical progression within 3 months of the most recent prior line of therapy
• Known history of hepatitis B or HIV infection
• Previous or concurrent malignancy except if curatively treated more than 3 years prior to enrollment
• Known active central nervous system (CNS) metastases
• Clinically significant pleural or pericardial effusion or peritoneal carcinomatosis
• Active treatment with antiviral agents
• History of severe hypersensitivity to fludarabine or cyclophosphamide
• Prior therapies/treatments with oncolytic viruses or T cell derived cellular therapy

Sponsors & Collaborators

• Dispatch Biotherapeutics: lead
• Bristol-Myers Squibb: collaborator

Study Sites (2)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Adenocarcinoma Of Esophagus; Adenoviridae Infections; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; DNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Dispatch Clinical

CONTACT

(215) 792-4699; clinicaltrials@dispatchbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2046
• Study Completion (Estimated): April 1, 2046
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)