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.
Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, colorectal adenocarcinoma, or biliary tract carcinoma
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
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
Single group
DISP-10
Biological/VaccineParticipants 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.
Incidence of Treatment Emergent Adverse Events (TEAEs)
Graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v6.0
Incidence of Dose Limiting Toxicities (DLTs) [PART 1]
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]
To select the Recommended Dose for Expansion (RDE) for Part 2
Overall response rate (ORR) [PART 2]
Confirmed complete response (CR) or partial response (PR), per RECIST v1.1
Overall response rate (ORR) [PART 1]
Confirmed CR or PR, per RECIST v1.1
Disease control rate (DCR)
Proportion of participants with CR, PR, or stable disease per RECIST v1.1
Duration of response (DOR)
Time from CR or PR to radiographic progression or death
Progression Free Survival (PFS)
Time from ide-cel administration to disease progression or death, whichever occurs first
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Dispatch Biotherapeutics
Lead sponsor
Bristol-Myers Squibb
Collaborator
