Recruiting
Phase 1

DISP-10

Sponsor:

Dispatch Biotherapeutics

Code:

NCT07544589

Conditions

Colorectal Cancer

Gastric Adenocarcinoma

Esophageal Adenocarcinoma

Gastroesophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DISP-10

Study Details

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

Study ID

NCT07544589

Start date

Apr 13, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2046

Anticipated

Primary completion date

Apr, 2046

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Study Design

Enrollment

66 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Primary outcome measure

  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 90 days (2 years for related Serious Adverse Events) ]
  • Incidence of Dose Limiting Toxicities (DLTs) [PART 1] [ Time Frame: 28 days ]
  • Identification of the Recommended Dose for Expansion (RDE) [PART 1] [ Time Frame: Up to 2 years ]
  • Overall response rate (ORR) [PART 2] [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

University of Cincinnati Cancer Center

Recruiting

Cincinnati, Ohio, United States, 45267

More Information

Sponsor

Dispatch Biotherapeutics

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dispatch Biotherapeutics on 2026-08-27.