Cell Therapy Clinical Trials
A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
Learn moreWhat is the purpose of this 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.
Eligibility
Key Inclusion Criteria:
- Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, or colorectal adenocarcinoma
- 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
- 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
- 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
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers
- Disease Type/ConditionColorectal Carcinoma, Colorectal Cancer, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Gastroesophageal Adenocarcinoma
- Principal InvestigatorCarlos R. Becerra, MD
- Co-InvestigatorsBenjamin Goldenson, MD, Raghuveer Ranganathan, MD, Alain Mita, MD, Chelsea Brown, NP
- Age GroupAdult, Older Adult
- PhaseI
- ClinicalTrials.gov IDNCT07544589
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Lauren Wagner
lauren.wagner@hoag.org
Hoag Family Cancer Institute
Hoag Family Cancer Institute delivers advanced, compassionate cancer care across Orange County, with multidisciplinary specialists, precision therapies, support services, and access to 125+ cancer clinical trials. Patients benefit from research-driven care across a wide range of cancers, including breast, lung, gynecologic, prostate, gastrointestinal, and blood cancers.
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