Cell & Gene Therapy: Safety and Clinical Activity in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

Case study

Cell and gene therapy trials can present a multitude of challenges. Aixial Group experts employ real time insights and hands-on management to expedite dosing escalation reviews, ensure proactive management of IP, and provide enhanced site support.

See how it’s done by checking out this case study: Aixial Group CellGene Therapy Case Study_Safety and Clinical Activity in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

Trial Summary

Phase I/II, Single-Arm, Open-Label, Multi-Centre Study Evaluating the Safety and Clinical Activity of [IP], a CAR T Cell Treatment in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

Design

  • 3+3 escalation to expansion
  • Escalation: up to 30 patients
  • Expansion: up to 101 patients

Product: Autologus T Cell product transduced to express [x] CAR
Sites: 6 UK and 7 US
Dates: 2017 to Present

Successes

  • Strong LCRA and CRAs better suited to manage sites via data/performance/risk metric visibility in encapsia
  • Bespoke site support via tailored site visits frequency, knowledge on IP and study as well as CRA availability to site
  • The site and patient engagement have been good. Rare screen fails
  • Minimal time to dose-escalation review and decisions supported by encapsia exports and insights

Figure 1 Real time, customizable results over time insights facilitate ongoing safety oversight

Figure 2. Real time AE/CM activity vs dosing visibility to support dosing level decisions

Challenges with Mitigations

  • IP distribution by couriers mitigated by ID of new courier with clear expectations
  • Manufacturing slots are prime, even within Sponsor facilities. Slot management is addressed at every team meeting and managed proactively. Transparency with site from beginning of the study
  • Challenges with keeping site support high mitigated by an increase in logistics management for samples

Reach out to us at info@aixial.com

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