Trial Snapshot
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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 |
Key Challenges of this Autologous Cell Therapy Clinical Trial
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.
The Precision Solution for Complex Cell Therapy Trial Management
Country-Specific Regulatory Mapping
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.
Targeted Site Selection & Pathway Validation
Using a layered feasibility and feasibility questionnaire process, Precision identified and qualified sites with:
- Cell therapy & apheresis experience
- JACIE/FACT accreditation
- Phase 1 unit capacity
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.
Operationalizing Pre-screening & Sample Flow
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.
Cohort and Communication Management
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.
Specialized Logistics Oversight
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.
Monitoring and Safety Infrastructure
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.
Measurable Outcomes and ROI for Cell Therapy Sponsors
- Site Activation Efficiency: Achieved cross-border site start-up across WEU, CEEU, and the US despite non-harmonized GMO/IVD frameworks.
- Regulatory Readiness: Minimized regulatory delays through early engagement and proactive country-specific planning.
- Logistics Execution: Maintained uninterrupted sample and IP flow across multiple geographies with no loss events.
- Patient Screening Resilience: Overcame lower-than-expected HLA match rates by adjusting pre-screening volume without delaying cohort timelines.
- Safety & Data Integrity: Aligned safety reviews and data availability for efficient dose-escalation decision-making.
Strategic Implications for Cell Therapy Sponsors
This study underscores the critical importance of:
- Country-specific regulatory foresight in cell therapy trials
- Integrated logistics and patient pathway planning
- Role-specific oversight (e.g., Logistics Coordinator) to maintain sample/IP integrity
- Continuous training and communication to support site staff navigating complex protocols
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.
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