DISP-10: 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 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of Treatment Emergent Adverse Events (TEAEs) — 90 days (2 years for related Serious Adverse Events) Graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v6.0
Incidence of Dose Limiting Toxicities (DLTs) [PART 1] — 28 days Graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v6.0
Identification of the Recommended Dose for Expansion (RDE) [PART 1] — Up to 2 years To select the Recommended Dose for Expansion (RDE) for Part 2
Overall response rate (ORR) [PART 2] — Up to 2 years Confirmed complete response (CR) or partial response (PR), per RECIST v1.1
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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