Actively Recruiting
A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers
Led by Dispatch Biotherapeutics · Updated on 2026-05-29
66
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Dispatch Biotherapeutics
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating DISP-10, a combination therapy made up of DV-10 (an adenovirus) and idecabtagene vicleucel (ide-cel, a BCMA-directed CAR T cell therapy), in adults with advanced gastrointestinal cancers. This Phase 1, multicenter, open-label study aims to assess the safety, tolerability, and potential effectiveness of DISP-10 in people with advanced or metastatic colorectal, gastric, esophageal, or gastroesophageal adenocarcinoma. The study is sponsored by Dispatch Biotherapeutics and is divided into two parts: dose-escalation and dose-expansion. Participants will receive DISP-10, which involves leukapheresis to collect blood cells for ide-cel production. During this process, bridging therapy may be given as needed for disease control. Before ide-cel infusion, patients will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide. The first part of the study focuses on finding the recommended dose for expansion by testing increasing doses of DISP-10, while the second part evaluates safety and effectiveness at this dose. During the study, participants will be closely monitored for treatment-related side effects, dose-limiting toxicities, and overall response to therapy for up to two years. Researchers will assess outcomes such as disease control, duration of response, progression-free survival, and overall survival, with some follow-up extending up to fifteen years. Safety monitoring includes tracking adverse events for 90 days, and serious adverse events related to the treatment will be observed for two years.
CONDITIONS
Brief Title
A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, or colorectal adenocarcinoma
- Measurable disease according to RECIST v1.1 with at least one additional site amenable to biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age 18 years or older at time of signing informed consent
- Adequate organ function
You will not qualify if you...
- Previous solid organ or hematopoietic cell transplant
- Evidence of rapid disease progression within 3 months of most recent prior therapy
- Known history of hepatitis B or HIV infection
- Previous or concurrent malignancy unless curatively treated more than 3 years prior
- Known active central nervous system 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 with oncolytic viruses or T cell derived cellular therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
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. 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.
Visits scheduled as per treatment and monitoring requirements
Duration - Up to 15 years
Participants will be monitored for safety and efficacy outcomes including treatment emergent adverse events, dose limiting toxicities, and overall response rates.
Regular follow-up visits over the study period
Trial Site Locations
Total: 3 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
3
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
D
Dispatch Clinical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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