Cell & Gene Therapy: 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