FDA granted an investigational device exemption (IDE) for Adaptive Biotechnologies’ ClonoSeq assay to be used in Imviva Biotech’s TENACITY-01 trial of CTD402, an allogeneic anti-CD7 CAR T therapy. The open-arm Phase Ib/II study will use ClonoSeq to identify and track minimal residual disease (MRD), including eligibility for MRD levels at or above 0.1%. Adaptive said ClonoSeq can detect one cancer cell in 1 million healthy cells. The trial plans to quantify MRD in post-treatment bone marrow for exploratory analyses aimed at MRD-guided intervention strategies. The IDE expands the MRD-assay role from monitoring into active trial design, reflecting the field’s shift toward MRD-defined risk stratification for cell-therapy development.