A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Trial sites (7)

Other trials for the same condition