FDA granted an investigational device exemption (IDE) for the use of Adaptive Biotechnologies’ ClonoSeq assay in a clinical trial sponsored by Imviva Biotech. The TENACITY-01 study evaluates Imviva’s allogeneic anti-CD7 CAR T-cell therapy CTD402 in relapsed or refractory T-cell ALL/LBL and in remission settings with minimal residual disease. ClonoSeq will be used to identify patients with MRD levels at or above 0.1%, a threshold Imviva and Adaptive said supports enrollment and exploratory analyses, including post-treatment marrow quantification. Adaptive reported that ClonoSeq can detect one cancer cell in 1 million healthy cells. The IDE approval signals growing integration of MRD technologies into CAR-T trial design—especially for allogeneic approaches—where sensitive, standardized measurement can shape risk stratification and trial decision-making.