FDA has granted an investigational device exemption for Adaptive Biotechnologies’ ClonoSeq assay to be used in a clinical trial sponsored by Imviva Biotech. The TENACITY-01 open-arm Phase Ib/II study evaluates Imviva’s allogeneic anti-CD7 CAR T-cell therapy CTD402 in relapsed or refractory T-ALL/LBL and in remission settings with measurable MRD. ClonoSeq will support enrollment eligibility using an MRD threshold of 0.1% or higher and will quantify MRD in bone marrow samples for exploratory analyses. The sponsor said the approach aligns with the growing move toward MRD-guided decisions and higher sensitivity MRD monitoring across diverse clinical settings.