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NCT Number: NCT07544589

A Phase 1 Study Evaluating 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.

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Key information

Conditions

Colorectal Cancer Adenocarcinoma Of Esophagus Adenoviridae Infections Colonic Diseases Colorectal Neoplasms DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Esophageal Adenocarcinoma Gastric Adenocarcinoma Gastroesophageal Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Infections Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope, Duarte, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Overall response rate (ORR) [PART 2]

    Time frame: Up to 2 years

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

Secondary outcomes

  1. Overall response rate (ORR) [PART 1]

    Time frame: Up to 2 years

    Confirmed CR or PR, per RECIST v1.1

  2. Disease control rate (DCR)

    Time frame: Up to 2 years

    Proportion of participants with CR, PR, or stable disease per RECIST v1.1

  3. Duration of response (DOR)

    Time frame: Up to 2 years

    Time from CR or PR to radiographic progression or death

  4. Progression Free Survival (PFS)

    Time frame: Up to 2 years

    Time from ide-cel administration to disease progression or death, whichever occurs first

  5. Overall survival (OS)

    Time frame: Up to 15 years

    Time from ide-cel administration to death

  6. Time to response (TTR)

    Time frame: Up to 2 years

    Time from ide-cel administration to the first documentation of objective tumor response

  7. Cellular kinetics (CK) of ide-cel

    Time frame: Up to 2 years

    Measurement of ide-cel CK in the blood

  8. Pharmacokinetics of DV-10 - Cmax

    Time frame: Up to 2 years

    Maximum concentration in blood

  9. Pharmacokinetics of DV-10 - Tmax

    Time frame: Up to 2 years

    Time to maximum concentration in blood

  10. Pharmacokinetics of DV-10 - AUC

    Time frame: Up to 2 years

    Area under the blood concentration curve

Study contacts

Contact information is provided by the study sponsor or research team.

Dispatch Clinical

CONTACT

[email protected]

(215) 792-4699

Sponsors and collaborators

Lead sponsor

Dispatch Biotherapeutics

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2046
Study completion
2046
First posted
Apr 22, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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