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RecruitingInterventionalPhase 1

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

NCT ID: NCT07544589Sponsor: Dispatch BiotherapeuticsLast updated: 2026-05-29

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.

Arms & interventions

  • BiologicalDISP-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.

Outcome measures

Primary

  • Incidence of Treatment Emergent Adverse Events (TEAEs)

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

    Time frame: 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

    Time frame: 28 days

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

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

    Time frame: Up to 2 years

  • Overall response rate (ORR) [PART 2]

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

    Time frame: Up to 2 years

Secondary

  • Overall response rate (ORR) [PART 1]

    Time frame: Up to 2 years

  • Disease control rate (DCR)

    Time frame: Up to 2 years

  • Duration of response (DOR)

    Time frame: Up to 2 years

  • Progression Free Survival (PFS)

    Time frame: Up to 2 years

  • Overall survival (OS)

    Time frame: Up to 15 years

  • Time to response (TTR)

    Time frame: Up to 2 years

  • Cellular kinetics (CK) of ide-cel

    Time frame: Up to 2 years

  • Pharmacokinetics of DV-10 - Cmax

    Time frame: Up to 2 years

  • Pharmacokinetics of DV-10 - Tmax

    Time frame: Up to 2 years

  • Pharmacokinetics of DV-10 - AUC

    Time frame: Up to 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (3)

City of Hope

Duarte, California, 91010

Recruiting

University of Cincinnati Cancer Center

Cincinnati, Ohio, 45267

Recruiting

Tennessee Oncology

Nashville, Tennessee, 37203

Recruiting