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Indication: |
Solid Tumors, Biomarker-Selected |
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Trial Phase: |
Phase 1-2 (Dose Escalation + Expansion) |
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Patient Population: |
Advanced/metastatic, HLA-restricted |
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Geography: |
Western Europe (WEU) - BE, DE, ES, UK |
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Study Duration: |
Multi-year |
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Sites Activated: |
Multiple, with phased expansion |
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Primary Challenge: |
Highly complex logistics, site readiness, and cross-border regulatory fragmentation |
This autologous cell therapy study required a uniquely high degree of operational precision. The sponsor needed to escalate and expand across Europe and North America while targeting a biomarker-specific, solid tumor population with complex eligibility and pre-screening requirements. Trial viability hinged on overcoming country-specific regulatory hurdles, navigating non-harmonized GMO approvals, coordinating high-stakes logistics for apheresis and cell therapy workflows, and ensuring site readiness for highly specialized procedures.
The Sponsor was under pressure to maintain momentum in a fast-moving clinical space—while ensuring patient safety, cross-functional cohesion, and strict adherence to regulatory and data integrity standards.
Precision proactively mapped all GMO, IVD, and Dx requirements by country, highlighting critical differences between centralized and site-specific biosafety review processes. The regulatory team developed playbooks to guide site start-up based on local review structures.
Using a layered feasibility and feasibility questionnaire process, Precision identified and qualified sites with:
Separate feasibility evaluations for apheresis sites included interviews to map patient pathways and confirm cross-departmental readiness, with on-site pre-study visits used to verify capabilities.
The trial required archived biopsy retrieval, centralized HLA genotyping, and interdepartmental coordination for patient identification (e.g., Derm, GI, Gyn, Med Onc etc). Precision created a non-interventional pre-screening protocol (EC review only), which enabled rapid identification and eligibility verification.
Centralized cohort management, including a dedicated central mailbox, real-time tracking, patient slot allocation forms, and continuous training via quick reference guides, enabled clean execution at scale.
A dedicated Logistics Coordinator oversaw packaging, transport, and tracking of samples and investigational product (IP). Dry runs at site initiation visits (SIVs) and robust chain-of-custody workflows ensured seamless transitions between pre-screening and interventional phases.
Precision implemented biweekly investigator and safety review meetings, aligned monitoring visits with dose escalation points, and ensured site readiness to detect and mitigate cytokine release syndrome (CRS) or other safety signals. Data entry expectations were clearly communicated, enabling rapid collation for safety decision-making.
This study underscores the critical importance of:
For sponsors pursuing novel cell therapies in solid tumor populations, this case demonstrates how Precision’s layered feasibility, rigorous cohort control, and real-time operational intelligence mitigated high-stakes risk while accelerating trial progress.