ImaginAb announced the launch of its Phase IIb “iPREDICT” trial in January 2022, as it continues to develop clinical data to support marketing approval of its pioneering CD8 ImmunoPET agent (zirconium Zr 89 crefmirlimab berdoxam).
The Phase IIb trial, called ‘iPREDICT’ (NCT05013099), aims to assess ‘predictive’ performance with its primary objective to evaluate the performance of 89Zr-Df-crefmirlimab positron emission tomography/computed tomography (PET/CT) for predicting patient response to immunotherapy.
The trial has a target of enrolling 80 patients over 22 sites across US, Australia, and Europe and has received approval from national and local health authorities in the US, Australia and Europe.Find out more information
The Phase IIb trial builds on the data from the company’s Phase IIa ‘BOT’ (Baseline On/Treatment) Trial, which completed enrollment last November. This followed the completion of our Phase I trials.
The aim was to evaluate the safety, tolerability and biodistribution of zirconium Zr 89 crefmirlimab berdoxam in human, and the optimal protein dose, as well as optimal detection of CD8+ activity by PET/CT imaging to determine recommended phase 2 dose (RP2D).
The goal of the Phase 1 Study of CD8+ Imaging in Inclusion Body Myositis Patients was to determine the ability of 89Zr-Df-IAB22M2C PET/CT to detect CD8 PET signal in skeletal muscle inflammation sites.
The principle objectives were to evaluate safety of repeat doses of zirconium Zr 89 crefmirlimab berdoxam and to establish the relationship between CD8+ ImmunoPET lesion uptake with CD8+ by immunohistochemistry (IHC) analysis.
The trial (NCT05013099), which was launched in January 2022, aims to assess ‘predictive’ performance. Its primary objective is to evaluate the performance of zirconium Zr 89 crefmirlimab berdoxam positron emission tomography/computed tomography (PET/CT) for predicting patient response to immunotherapy.Find out more about our iPREDICT trial here
Whether a clinician, commercial organization or patient, find our network of clinical trials listed below.
Our operations can support clinical trials within North America, Europe, and Australia.View all clinical trials