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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
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.
City of Hope
Duarte, California, United States
RECRUITINGHoag Memorial Hospital Presbyterian
Newport Beach, California, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGUniversity of Cincinnati Cancer Center
Cincinnati, Ohio, United States
RECRUITINGTennessee Oncology
Nashville, Tennessee, United States
NOT_YET_RECRUITINGIncidence 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
Overall response rate (ORR) [PART 1]
Confirmed CR or PR, per RECIST v1.1
Time frame: Up to 2 years
Disease control rate (DCR)
Proportion of participants with CR, PR, or stable disease per RECIST v1.1
Time frame: Up to 2 years
Duration of response (DOR)
Time from CR or PR to radiographic progression or death
Time frame: Up to 2 years
Progression Free Survival (PFS)
Time from ide-cel administration to disease progression or death, whichever occurs first
Time frame: Up to 2 years
Overall survival (OS)
Time from ide-cel administration to death
Time frame: Up to 15 years
Time to response (TTR)
Time from ide-cel administration to the first documentation of objective tumor response
Time frame: Up to 2 years
Cellular kinetics (CK) of ide-cel
Measurement of ide-cel CK in the blood
Time frame: Up to 2 years
Pharmacokinetics of DV-10 - Cmax
Maximum concentration in blood
Time frame: Up to 2 years
Pharmacokinetics of DV-10 - Tmax
Time to maximum concentration in blood
Time frame: Up to 2 years
Pharmacokinetics of DV-10 - AUC
Area under the blood concentration curve
Time frame: Up to 2 years
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