Accelerated, scalable same-day microfluidic sequential gene editing for allogeneic cell therapy

Federal Grant Award Summary

Cellfe, Inc. received a Phase I Small Business Innovation Research (SBIR) grant of $314,000 from the National Institute of General Medical Sciences (NIGMS) under the Biomedical Research and Research Training program (CFDA 93.859) for the period of September 1, 2025 through August 31, 2026. The company will conduct proof-of-concept research and development to optimize and validate the CellFE platform, a microfluidic transfection technology designed to enable accelerated, same-day sequential multiplexed gene editing of T cells for allogeneic cell therapies. The research will demonstrate the feasibility of performing CRISPR-based gene editing within a single day while minimizing cytotoxicity and genomic instability risks.

The deliverables under this award include validation studies establishing high-efficiency, same-day multiplexed gene editing capabilities to streamline allogeneic CAR-T cell manufacturing. By addressing the critical bottleneck of delayed cell manufacturing processes, this technology development initiative will advance the scalability and clinical translation of off-the-shelf cell therapies for cancer treatment. The research will support NIGMS's mission to fund investigator-initiated biomedical research that establishes the foundation for advances in disease diagnosis, treatment, and prevention.

Abstract

Allogeneic therapies hold significant promise as off-the-shelf treatments, offering faster and more accessible alternatives to autologous therapies. However, current allogeneic car-t manufacturing faces challenges in preventing immune rejection and alloreactivity. These challenges are particularly pronounced in gene-editing processes, where multiple gene edits are required to modify donor t cells for immune tolerance, but existing gene delivery tools present limitations like slow recovery times, high cytotoxicity, and scaling difficulties for large- scale production. This project aims to optimize the cellfe platform, a novel microfluidic transfection technology, to enable same-day sequential multiplexed gene editing of t cells for allogeneic therapies. By enhancing the speed, precision, and scalability of crispr-based gene editing, the proposed approach will streamline t cell manufacturing, improving therapeutic potency while minimizing the risk of chromosomal instability or genomic translocations, which are common concerns in gene-edited therapies. The innovation of this work lies in its ability to perform sequential gene editing within a single day, ensuring efficient gene editing with minimal cytotoxicity and genomic instability. This approach will accelerate clinical translation by addressing the critical bottleneck of delayed manufacturing and enabling rapid scaling of allogeneic car-t cell production. In this phase i sbir grant, we will conduct a series of proof-of-concept studies to demonstrate the feasibility of the cellfe platform for high efficiency, same-day multiplexed gene editing. By validating the cellfe platform for same-day multiplexed gene editing, this project will significantly improve the efficiency and scalability of allogeneic car-t therapies, advancing the field of off-the-shelf cell therapies for a variety of cancers and other diseases.