Sponsored by the biotechnology company Zelluna Immunotherapy (Zelluna), ZIMA-101 is a complex first-in-human, first-in-class Phase I clinical trial. As Zelluna’s first clinical trial and the first clinical translation of its TCR-NK platform, establishing ZIMA-101 presented several novel operational challenges.  

Zelluna identified The Christie NHS Foundation Trust as a potential lead site and initiated early engagement with Professor Fiona Thistlethwaite. As iMATCH ATTC Director, Professor Thistlethwaite was able to understand the company’s support needs for the trial’s novel operational challenges and connect Zelluna with the Cell and Gene Therapy Catapult (CGT Catapult). Through early and sustained engagement between Zelluna, the multidisciplinary team at The Christie, and the CGT Catapult, the key challenges for the ZIMA-101 clinical trial were successfully addressed. 

Through this collaborative approach, with Professor Fiona Thistlethwaite acting as Global Chief Investigator, The Christie became the first site globally to open the ZIMA-101 clinical trial and consented the first patient 89 days after HRA approval and 126 days from application submission. This timeline comfortably met the UK Government’s target for clinical trials to open and recruit their first participant within 150 days. 

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