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

August 25, 2026 updated by: Dispatch Biotherapeutics

A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital Presbyterian
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Tennessee Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame: 90 days (2 years for related Serious Adverse Events)
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]
Time Frame: 28 days
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]
Time Frame: Up to 2 years
To select the Recommended Dose for Expansion (RDE) for Part 2
Up to 2 years
Overall response rate (ORR) [PART 2]
Time Frame: Up to 2 years
Confirmed complete response (CR) or partial response (PR), per RECIST v1.1
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) [PART 1]
Time Frame: Up to 2 years
Confirmed CR or PR, per RECIST v1.1
Up to 2 years
Disease control rate (DCR)
Time Frame: Up to 2 years
Proportion of participants with CR, PR, or stable disease per RECIST v1.1
Up to 2 years
Duration of response (DOR)
Time Frame: Up to 2 years
Time from CR or PR to radiographic progression or death
Up to 2 years
Progression Free Survival (PFS)
Time Frame: Up to 2 years
Time from ide-cel administration to disease progression or death, whichever occurs first
Up to 2 years
Overall survival (OS)
Time Frame: Up to 15 years
Time from ide-cel administration to death
Up to 15 years
Time to response (TTR)
Time Frame: Up to 2 years
Time from ide-cel administration to the first documentation of objective tumor response
Up to 2 years
Cellular kinetics (CK) of ide-cel
Time Frame: Up to 2 years
Measurement of ide-cel CK in the blood
Up to 2 years
Pharmacokinetics of DV-10 - Cmax
Time Frame: Up to 2 years
Maximum concentration in blood
Up to 2 years
Pharmacokinetics of DV-10 - Tmax
Time Frame: Up to 2 years
Time to maximum concentration in blood
Up to 2 years
Pharmacokinetics of DV-10 - AUC
Time Frame: Up to 2 years
Area under the blood concentration curve
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dispatch Biotherapeutics

Collaborators

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2026

Primary Completion (Estimated)

April 1, 2046

Study Completion (Estimated)

April 1, 2046

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DISP-10-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe