Metaclipse Therapeutics
PROJECT
Regulatory Approval and Site Activation for a First-in-Human Cancer Vaccine Trial
ROLE
Project Manager, Clinical Operations
TIMELINE
November 2025 – July 2026
TEAM
See team matrix below
Site(s)
The University of Texas MD Anderson Cancer Center
Investigational Agent
Membrex™ (TMV Vaccine-P)
A personalized autologous tumor-derived membrane vesicle (TMV) vaccine combined with hB7-1 and hIL-12 immune-stimulatory proteins
Study Design
Phase 1a/1b, open-label, dose-escalation oncology trial
Disease Area
Head and neck squamous cell carcinoma (HNSCC)
NCT pending
01 Summary
Metaclipse is a small biotech start-up developing Membrex™, a personalized cancer vaccine made from a patient's own tumor. I helped move Membrex toward its first human trial: getting the protocol approved by MD Anderson's review board, and negotiating the contracts that let the trial site open.
CORE COMPETENCIES:
Contract Development and Negotiation, Vendor Management, Regulatory Correspondence, Clinical Operations, Project Management, Document Control, Study Start-Up
02 Approach
I led the hospital's IRB submission from initial filing through final approval, owning all communication with local and federal regulatory bodies and resolving agency queries as they came up. Where a study modification was needed to keep approval moving forward, I led that too. In parallel, I coordinated site setup: contracts, staff training, and study software, so the site could open the moment approval came through. I also negotiated contracts with the hospital, software vendors, and service partners, setting terms for risk, data, and ownership.
03 Impact
After a decade in the lab at Emory University, Metaclipse's science reaches patients. This is the point where a discovery becomes a clinical program, marked by the first time the therapy is tested in humans and the first data set that can support an FDA submission. The regulatory and contractual groundwork laid here, the approvals secured, the terms negotiated, becomes the foundation the program's patent protections and future trial sites stand on.