Cell therapy represents one of the most promising frontiers in oncology, offering personalized treatment options that harness the patient’s own immune system. But with this promise comes complexity. This Phase 1-2 trial targeted two specific antigens in patients with advanced solid tumors—a population notoriously difficult to recruit and treat.
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Study Type |
Phase 1-2 |
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Therapeutic Area |
Cell Therapy |
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Indication |
Advanced-stage solid tumors expressing two specific antigens |
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Geography |
Global |
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Sites |
14 Sites, >45 Patients |
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Precision’s Role |
End-to-end operational support including site selection, logistics coordination, and monitoring strategy |
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Key Challenges |
Regulatory hurdles, patient identification, logistics coordination, site readiness, and sample management |
Precision was engaged to support the operational execution of this global study, which required navigating complex regulatory requirements, coordinating logistics across borders, and ensuring site readiness for a highly specialized therapeutic approach.
Cell therapy clinical trials often face heightened scrutiny from regulatory bodies due to their novel mechanisms and safety profiles. In this study, early engagement with Institutional Biosafety Committees (IBCs), pharmacy units, and cell labs was essential. Precision facilitated these conversations, helping sites understand the unique procedural and documentation requirements.
Site contracting and budgeting were also triggered early to avoid delays, and walkthroughs during pre-study visits (PSVs) ensured that each site had the infrastructure and workflows to manage the full patient and product lifecycle—from starting material procurement to infusion.
Recruiting patients for cell therapy clinical trials is a challenge in itself. The inclusion criteria often require specific antigen expression, which narrows the eligible population significantly. Precision leveraged feasibility assessments and historical performance data to identify sites with access to the right patient populations and experience in cellular therapies.
Sites were trained extensively on toxicity management, ICU protocols, and procedural nuances such as conditioning therapy and pre/post-infusion prophylaxis. Dry runs at site initiation visits (SIVs) helped validate readiness and surface any gaps in process flow.
The logistics of cell therapy are unlike any other. From the collection and labeling of starting material to the shipment and infusion of the investigational product (IP), every step must be tightly controlled and traceable.
Precision deployed a dedicated logistics coordinator to oversee:
This role proved critical in maintaining consistency and avoiding disruptions across global sites.
Precision implemented a front-loaded monitoring strategy, with site monitoring visits (SMVs) scheduled immediately after starting material procurement and again post-infusion. This approach allowed for early data cleaning and rapid issue resolution, ensuring high-quality data and compliance throughout the study.
Despite the inherent complexity of cell therapy trials, this study progressed smoothly, with no major data issues reported. Precision’s proactive planning, deep therapeutic expertise, and hands-on coordination enabled sites to execute confidently and compliantly.