- Cellares and TScan Therapeutics have entered into an agreement to evaluate automated clinical manufacturing of TSC-101, a TCR-engineered T cell therapy candidate for acute myeloid leukemia and myelodysplastic syndromes.
- The assessment will focus on automating manufacturing and quality testing processes using Cellares’ Cell Shuttle and Cell Q platforms as TScan prepares for a pivotal trial expected to begin in the second quarter of 2026.
Cellares and TScan Therapeutics have announced an agreement to evaluate automated clinical manufacturing of TSC-101, TScan’s lead TCR-engineered T cell therapy candidate for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The collaboration will involve a technical and operational assessment of Cellares’ automated manufacturing and testing platforms as TScan advances the therapy toward a pivotal clinical trial expected to begin in the second quarter of 2026.
TSC-101 is designed to treat residual disease and prevent relapse in patients with AML and MDS undergoing allogeneic hematopoietic cell transplantation. The therapy uses a gene modification approach to engineer T cells from healthy donors into patient-specific cell therapy products. According to TScan, the evaluation is intended to determine whether Cellares’ automated manufacturing technology can support future commercial demand through a scalable and cost-efficient production model.
Under the agreement, Cellares will automate the manufacturing and testing processes for TSC-101 using its Cell Shuttle end-to-end manufacturing platform and Cell Q automated quality control and release testing system. The companies stated that these automated workflows are designed to reduce process variability, lower labor requirements, and support consistent manufacturing execution across facilities and geographic regions.
“As we prepare for the initiation of our pivotal study of TSC-101 this quarter, we are increasing our efforts for commercial readiness. Establishing a scalable and cost-efficient manufacturing strategy is a critical component.”
Ray Lockard, Chief Manufacturing and Quality Officer of TScan Therapeutics
The collaboration adds TCR-engineered T cell therapies to Cellares’ portfolio of automated cell therapy modalities, which already includes CAR-T therapies, hematopoietic stem cell programs, and autologous progenitor T cell therapies. The companies said the assessment is intended to support long-term manufacturing readiness and broader patient access if TSC-101 advances toward commercialization.
