Adaptive Biotechnologies : Imviva Biotech Receives FDA IDE Authorization for clonoSEQ® Assay in TENACITY-01 Clinical Trial

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PDF Version Highly sensitive next-generation sequencing-based MRD testing will identify eligible patients with T-cell malignancies for trial enrollment and precisely evaluate treatment response BOSTON, June 30, 2026 (GLOBE NEWSWIRE) -- Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted authorization for its Investigational Device Exemption (IDE) application for the use of Adaptive Biotechnologies' clonoSEQ® assay in the TENACITY-01 clinical trial (NCT07070219). The TENACITY-01 trial evaluates CTD402, Imviva's investigational allogeneic anti-CD7 CAR-T cell therapy, for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) and patients with T-ALL/LBL in first or second complete remission with minimal (or measurable) residual disease (MRD-positive). Next-generation sequencing-based clonoSEQ provides highly sensitive, reliable detection of MRD-small amounts of cancer that remain after treatment but are often missed by standard methods and can lead to relapse. The relationship between MRD status and relapse risk is well-established, and a threshold of 0.01% (10-4) is widely used as a clinically actionable cutoff to define high-risk disease and guide treatment escalation in ALL (National Comprehensive Cancer Network). The use of clonoSEQ will serve a dual purpose in the TENACITY-01 trial-identifying patients with MRD levels of 0.1% or higher for enrollment eligibility and detecting and quantifying MRD in post-treatment bone marrow samples to support exploratory analyses. IDE authorization signals that an assay is capable of being used in a highly regulated clinical development program where test results may be used for patient management. This IDE authorization enables the use of highly sensitive MRD assessment in the TENACITY-01 trial to identify eligible patients for enrollment and precisely evaluate treatment response. Despite improvements in remission rates for newly diagnosed T-ALL/LBL, particularly in pediatric populations, high relapse rates remain a significant challenge. MRD status is one of the strongest independent predictors of relapse and survival in ALL, with studies showing 10-year event-free survival rates of approximately 77% versus 32% for MRD-ne...

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