On June 30, 2026 Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, reported 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).

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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-negative versus MRD-positive pediatric patients (Berry et al., 2017).

"FDA authorization of our IDE is a significant step forward as we advance the TENACITY-01 clinical trial," said Jan Davidson-Moncada, MD, PhD, Imviva Biotech Chief Medical Officer. "Integrating clonoSEQ will allow us to more accurately monitor MRD and evaluate the durability of CTD402. These insights can accelerate clinical decision-making and ultimately support improved patient outcomes by enabling earlier intervention and more personalized treatment strategies."

"As the field moves increasingly toward MRD-guided treatment strategies, interventional clinical trials require MRD technologies that can deliver highly sensitive, standardized results across diverse clinical settings," said Mary Pat Lancelotta, Senior Vice President, MRD Biopharma at Adaptive Biotechnologies. "With its extensive clinical validation and broad use in hematologic malignancies, clonoSEQ is uniquely positioned to support these next-generation trial designs and help advance MRD-guided care for patients with T-ALL/LBL."

The ongoing global, single-arm, open-label TENACITY-01 trial is enrolling adolescents and adults (≥12 years) to evaluate the safety, efficacy, and cellular pharmacokinetics of CTD402. The current study will enroll up to 120 patients, divided between R/R and MRD-positive cohorts. All participants will receive a standard dose lymphodepletion (fludarabine/cyclophosphamide) and a flat dose of 400×10⁶ CTD402 CAR-T cells.

For more information, visit www.imvivabio.com.

About CTD402

CTD402 is an investigational ‘ready-at-point of care’ allogeneic anti-CD7 CAR-T cell therapy designed for T-cell mediated disease. The product candidate incorporates T-cell receptor (TCR) and HLA class II knockout, along with Imviva’s proprietary ANSWER inhibitory ligands to enhance resistance to host immune rejection. The robustness of CTD402’s manufacturing process, showing product consistency across multiple donors and production lots, promises to deliver an ‘off-the-shelf’ allogeneic platform with the critical advantage of immediate availability, eliminating manufacturing delays that can be life-threatening for patients with rapidly progressive disease.

A global Phase 1b/2 clinical trial (TENACITY-01) evaluating CTD402 for the treatment of relapsed/refractory T-ALL/LBL patients is enrolling patients (NCT07070219). The U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation (RPDD), and Regenerative Medicine Advanced Therapy (RMAT) designation to CTD402 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL).

(Press release, Imviva Biotech, JUN 30, 2026, View Source [SID1234669025])