A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers
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.
Arms & interventions
- BiologicalDISP-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.
Outcome measures
Primary
Incidence of Treatment Emergent Adverse Events (TEAEs)
Graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v6.0
Time frame: 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
Time frame: 28 days
Identification of the Recommended Dose for Expansion (RDE) [PART 1]
To select the Recommended Dose for Expansion (RDE) for Part 2
Time frame: Up to 2 years
Overall response rate (ORR) [PART 2]
Confirmed complete response (CR) or partial response (PR), per RECIST v1.1
Time frame: Up to 2 years
Secondary
Overall response rate (ORR) [PART 1]
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Progression Free Survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 15 years
Time to response (TTR)
Time frame: Up to 2 years
Cellular kinetics (CK) of ide-cel
Time frame: Up to 2 years
Pharmacokinetics of DV-10 - Cmax
Time frame: Up to 2 years
Pharmacokinetics of DV-10 - Tmax
Time frame: Up to 2 years
Pharmacokinetics of DV-10 - AUC
Time frame: Up to 2 years
Eligibility criteria
Study locations (3)
City of Hope
Duarte, California, 91010
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45267
Tennessee Oncology
Nashville, Tennessee, 37203