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

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