NEW YORK – CareDx announced Wednesday that it will use its AlloCell cell transplant surveillance tool to assist TC BioPharm with pharmacokinetic testing in the Phase II ACHIEVE clinical trial.
Financial details of the partnership were not disclosed.
The open-label ACHIEVE study is enrolling more than 50 patients with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) to evaluate the efficacy and effectiveness of TCB008, an allogeneic gamma-delta T-cell therapy. TCB008 is developed from unrelated, healthy donors' peripheral blood mononuclear cells, which are then expanded and activated before infusion into patients.
AlloCell, a next-generation sequencing-based tool that uses a panel of genomic signatures to gauge the levels of cell products, will be used to evaluate the expansion and persistence of TCB008 in ACHIEVE trial participants and to better understand the drug's duration and effect on gamma-delta T-cells in reconstituting the immune system.
"This partnership builds upon our growth strategy to expand into hematology oncology with pharmacokinetic and monitoring assays for patients undergoing cell therapy," Marica Grskovic, chief strategy officer for CareDx, said in a statement.
Brisbane, California-based CareDx also recently partnered with Dovetail Genomics to combine Dovetail's LinkPrep NGS chromatin conformation assay with CareDx's next-generation sequencing-based AlloSeq Tx 17 HLA typing test for HLA genotyping for organ and stem cell transplant matching.