NCT07544589 A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
| NCT ID | NCT07544589 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Dispatch Biotherapeutics |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2026-04 |
| Primary Completion | 2046-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 66 participants in total. It began in 2026-04 with a primary completion date of 2046-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07544589 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07544589 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07544589 currently recruiting?
Yes, NCT07544589 is actively recruiting participants. Contact the research team at clinicaltrials@dispatchbio.com for enrollment information.
Where is the NCT07544589 trial being conducted?
This trial is being conducted at Duarte, United States, Cincinnati, United States, Nashville, United States.
Who is sponsoring the NCT07544589 clinical trial?
NCT07544589 is sponsored by Dispatch Biotherapeutics. The trial plans to enroll 66 participants.
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