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

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: Colorectal Cancer; Gastric Adenocarcinoma; Gastroesophageal Adenocarcinoma; Esophageal Adenocarcinoma
• Intervention / Treatment: Biological: DISP-10

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dispatch Clinical; Phone Number: (215) 792-4699; Email: clinicaltrials@dispatchbio.com

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncology

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dispatch Biotherapeutics
• Collaborators: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 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): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CAR-T; gastrointestinal cancer; CAR T; BCMA; Adenovirus; ABECMA
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Infections; Virus Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; DNA Virus Infections; Colorectal Neoplasms; Gastrointestinal Neoplasms; Adenoviridae Infections; Adenocarcinoma Of Esophagus
• 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