Calibr, a division of Scripps Research focused on the “bench to bedside” development of transformative medicines, announced encouraging preliminary data from the first nine subjects in a first-in-human phase 1 clinical trial studying the first switchable CAR-T cell product (CLBR001 + SWI019) for patients with B-cell malignancies. The ongoing dose-escalation trial investigating the safety, tolerability and optimal dosing for Calibr’s next-generation “switchable” chimeric antigen receptor T-cell (sCAR-T) therapy platform is the first step toward development of a universal, more versatile and safer approach to cell therapy.
The results, presented at the CAR-TCR Summit 2022 in September, showed that CLBR001 + SWI019 achieved an overall response rate of 78% (7 of the first 9 evaluable patients) and a complete response of 67% (6 of 9 patients) as of the data cutoff of July 22, 2022. Subjects participating in the study were heavily pretreated with a median of five prior therapies, including a subject who previously received NK cell therapy. Most responses were achieved with just a single dose of CLBR001 cells and one cycle ofSWI019—with further cycles of SWI019showing evidence of deepening responses over time.
“These results underscore the potential of Calibr’s switchable CAR-T cell platform to act like a ‘software’ and ‘hardware’ approach, where the biological response of theCLBR001 cell ‘hardware’ can be programmed using the switch dose as the ‘software’,” said Travis Young, vice president of Biologics at Calibr. “This is our first step toward demonstrating the potential of this universal platform to be programmed toward any target, including those for solid tumors.”
The phase 1 trial investigating CLBR001 +SWI019 is ongoing in dose escalation. Nodose-limiting toxicities have been observed as of the data cutoff.
The sCAR-T platform technology was developed by Calibr, and a partnership with AbbVie has enabled this first-in-human trial. Expansion of the platform into solid tumors is currently underway.