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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Key Inclusion Criteria: 1. Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, colorectal adenocarcinoma, or biliary tract carcinoma 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 Additional criteria apply and should be discussed with the study site.
About the study
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.
What is being tested
- DISP-10 (biological)
Sponsor: Dispatch Biotherapeutics · Participants: 66 · Started: Apr 13, 2026
Contact the study team
- Dispatch Clinical · Phone: (215) 792-4699
Official record on ClinicalTrials.gov — NCT07544589
Locations in the U.S.
| California | City of Hope, Duarte Hoag Memorial Hospital Presbyterian, Newport Beach |
| Florida | Moffitt Cancer Center, Tampa |
| Massachusetts | Dana-Farber Cancer Institute, Boston |
| Ohio | University of Cincinnati Cancer Center, Cincinnati |
| Tennessee | Tennessee Oncology, Nashville (Not yet recruiting) |
| Utah | Huntsman Cancer Institute, Salt Lake City |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.