Colorectal CancerPhase 1NCT07544589
A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
A Phase 1 study testing DISP-10 in people with Colorectal Cancer and Gastric Adenocarcinoma, run by Dispatch Biotherapeutics at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Gastric Adenocarcinoma, Esophageal Adenocarcinoma
- What is being tested?
- DISP-10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Apr 2026to Apr 2046
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, colorectal adenocarcinoma, or biliary tract carcinoma
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
- Additional criteria apply and should be discussed with the study site.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45267
- Recruiting
City of Hope
Duarte, California, 91010
- Not yet recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: 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.
- Conditions
- Colorectal Cancer, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Gastroesophageal Adenocarcinoma, Biliary Tract Carcinoma
- Being tested
- DISP-10
- Keywords
- CAR T, Adenovirus, ABECMA, BCMA, gastrointestinal cancer, CAR-T
- Medical subject headings
- Colorectal Neoplasms, Adenocarcinoma Of Esophagus, Adenoviridae Infections, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISP-10Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| DISP-10 | Experimental | 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. Receives: Biological: DISP-10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (TEAEs)
Graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v6.0
Measured: 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
Measured: 28 days
Identification of the Recommended Dose for Expansion (RDE) [PART 1]
To select the Recommended Dose for Expansion (RDE) for Part 2
Measured: Up to 2 years
Overall response rate (ORR) [PART 2]
Confirmed complete response (CR) or partial response (PR), per RECIST v1.1
Measured: Up to 2 years
Secondary outcomes (10)
Overall response rate (ORR) [PART 1]
Confirmed CR or PR, per RECIST v1.1
Measured: Up to 2 years
Disease control rate (DCR)
Proportion of participants with CR, PR, or stable disease per RECIST v1.1
Measured: Up to 2 years
Duration of response (DOR)
Time from CR or PR to radiographic progression or death
Measured: Up to 2 years
Progression Free Survival (PFS)
Time from ide-cel administration to disease progression or death, whichever occurs first
Measured: Up to 2 years
Overall survival (OS)
Time from ide-cel administration to death
Measured: Up to 15 years
Time to response (TTR)
Time from ide-cel administration to the first documentation of objective tumor response
Measured: Up to 2 years
Cellular kinetics (CK) of ide-cel
Measurement of ide-cel CK in the blood
Measured: Up to 2 years
Pharmacokinetics of DV-10 - Cmax
Maximum concentration in blood
Measured: Up to 2 years
Pharmacokinetics of DV-10 - Tmax
Time to maximum concentration in blood
Measured: Up to 2 years
Pharmacokinetics of DV-10 - AUC
Area under the blood concentration curve
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start13 Apr 2026
- Primary completionApr 2046 (estimated)
- Study completionApr 2046 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dispatch Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544589
- Sponsor's protocol ID
- DISP-10-101
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No