Cell Therapy

Cell therapy clinical trials pose a number of challenges, including material supply risks due to single-source materials, temperature and time sensitivity throughout the supply chain process, the need for accelerated regulatory pathways and associated testing data, as well as CMC concerns. Additionally, viral vector development and manufacturing capacity and starting materials are becoming increasingly competitive and can affect lead times, while risks to clinical trial enrollment and screening failure remain high.

Cell Therapy Experienced Team

We have a growing pool of experienced cell therapy professionals in various roles, including: Executive Leaders, PMs, Clinical/Site Managers, Clinical Research Associates (CRAs), Medical Directors, Biostatisticians and Data Managers. From this pool, we select specific study team members who bring relevant disease and operational experience to execute each study.

Our CGT Working Group has proactively created several processes and tools for use on cell therapy trials which include:

  • Cell therapy training curriculum (CGT Academy)
  • Cell therapy-specific project plans
  • Cell therapy specific informed consent form (ICF) wording
  • Site Data Entry Projection and Management Tool
  • Logistics and Supply Management Process and Flow Sheets
  • Patient Flow Diagrams

Experience Summary

Logistics management

Cell therapy studies can be particularly complex and challenging in terms of sample management. This is especially true for cell/sample collection procedures, such as leukapheresis. We utilize a dedicated logistics coordinator (LC) role within the Caidya study team to ensure communication between sites, sponsor, and logistics vendors. The LC’s central role in coordinating shipping and tracking of samples, ensures proper chain of custody and subsequent treatment of patients with the targeted therapy. All of this requires careful timing and detail-oriented management.

Logistics coordinator responsibilities include:

  • Collaboration with multidisciplinary institutional teams to track lab values in anticipation of apheresis collection
  • Collection of specimens within a specific timeframe
  • Management of the therapy-specific storage and logistics from end to end to ensure timely and accurate delivery

Caidya offers dedicated LCs for each region in which the study is operating to support sites and vendors within their own time zones, as well as to ensure rapid response to questions and provide guidance and support as needed.

To ensure seamless logistics, we:

  • Coordinate with the sponsor (and vendors as needed) to ensure all aspects of the logistics are well-organized prior to initiating the sites, with a test run of the process where possible.
  • Create a logistics management plan and documentation with the sponsor to ensure proper handling, shipment, and accountability is completed on each sample at the site.
  • Train the sites on sample timing, storage, and shipment.
  • Maintain trackers for sample shipment, receipt at central and specialty labs, analysis, and return to sites for patient treatment.


Manufacturing considerations

Manufacturing failure rate is an important consideration in autologous cell therapy trials. If not already assessed, feasibility is often an endpoint of early-phase trials involving such products (e.g., failure-to-treat). In addition, as potential dose ranges can be substantial, management of scenarios in which a subject’s product cannot be manufactured to achieve the target dose should be explicitly described. Quality control/assurance parameters of the manufactured product will need to be explicitly stated, such as viability, purity, sterility, etc. Our CMC experts can assist with clearly delineating how manufacturing failures, delays, or quality issues should be handled.

Regulatory Strategy

Before enrolling patients in a cell therapy trial, the clinical trial protocol and investigational product must receive approval from local and country-level regulators. Sponsors must ensure their technology is acceptable in all countries in which they plan to operate to avoid incurring additional costs. In the U.S., studies may need to be reviewed by institutional biosafety committees (IBCs). In Europe, studies must meet the standards of the advanced therapy medicinal product (ATMP) directive and may need to be reviewed by national GMO experts. These steps are important to ensure proper handling procedures are implemented and patient or public safety is protected. It is essential for companies to understand the current regulatory landscape and anticipate any changes that may impact their development goals.

Caidya’s regulatory team has worked on many studies in cell therapy and has the expertise to help navigate this complex landscape.

Potential Risks and Mitigation Solutions

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