Poster presentation highlights promising results from Phase 1b/2 TENACITY-01 study of CTD402 in T-Cell and myeloid leukemias
Findings underscore potential to address unmet needs in multiple hematological malignancies, manufacturing innovation and advance patient care
BOSTON, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today presented data on two of its allogeneic cell therapy candidates for the treatment of multiple hematological malignancies, as well as its manufacturing innovation, in five poster presentations at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.
These presentations demonstrate the potential of the company’s investigational CD7 allogeneic CAR-T cell therapy, CTD402, to address some of the most challenging hematological malignancies with limited treatment options and high mortality rates, including T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) and severe aplastic anemia (SAA). In addition, a presentation displayed the potential of CTA311, the company’s allogeneic CD19-targeted CAR-T therapy in development for patients with Relapsed/Refractory (R/R) lymphoblastic leukemia (B-ALL). Both CTD402 and CTA311 incorporate T-cell receptor (TCR) and HLA knockout, along with Imviva's proprietary ANSWER™ inhibitory ligands to enhance resistance to host immune rejection.
The first poster (Abstract #5954) highlighted the promising ‘off-the-shelf' CAR-T approach of CTD402, being evaluated in the Phase 1b/2 TENACITY-01 clinical trial (NCT07070219) for the treatment of R/R T-ALL and LBL. The ongoing global, single-arm, open-label trial is enrolling adolescents and adults (≥12 years) to evaluate safety, efficacy, and cellular pharmacokinetics. Phase 1b will determine the recommended Phase 2 dose in ~18 patients, followed by Phase 2 enrollment of ~36 patients. All participants receive standard dose lymphodepletion (fludarabine/cyclophosphamide) and a flat dose of 400×10⁶ CTD402 CAR-T cells. Primary endpoints include incidence of dose-limiting toxicities and overall complete remission rate, while secondary endpoints assess pharmacokinetics. Preliminary data from earlier studies suggest CTD402 achieves high MRD-negative remission rates and durable responses, supporting its potential as a transformative therapy for R/R T-ALL/LBL.
The second CTD402 poster (Abstract #3210) details how the therapy can be used to treat SAA, a life-threatening bone marrow failure disorder driven by aberrant T-cell activity, with limited treatment options for patients unresponsive to immunosuppressive therapy. The ongoing Phase I trial (NCT06622694) uses a single-arm, open-label, 3+3 dose-escalation design to evaluate safety, tolerability, and determine the maximum tolerated dose in adults with R/R SAA. Secondary objectives include hematologic response rates at 3 and 6 months, duration of response, and pharmacokinetics, with exploratory endpoints assessing immune reconstitution biomarkers. Patients receive standard lymphodepletion followed by CTD402 infusion. This study aims to establish CTD402 as a first-in-class cellular therapy for SAA.
The final CTD402 poster (Abstract #4180) demonstrated that Imviva’s standardized manufacturing process effectively mitigates donor and lot variability while delivering consistent clinical outcomes. Analysis of 18 production lots from 13 donors and 64 patients with R/R T-ALL/LBL showed robust product quality and pharmacokinetics across three optimized process stages, with low intradonor variability, and robust efficacy across all processes and donors. These findings underscore CTD402’s potential as a scalable CAR-T solution that combines manufacturing reliability with strong clinical performance, offering a cost-efficient alternative to autologous CAR-T therapies.
“About 20% of children and 40% of adults with T-ALL/LBL relapse after first-line therapy, leaving few options and high mortality,”1 said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, MD, PhD. “CTD402 is designed to potentially overcome current limitations by providing effective leukemia clearance with manageable safety using standard-dose lymphodepletion. These findings mark an important step toward addressing this critical unmet need through our global TENACITY-01 study, now enrolling patients.”
A poster (Abstract #5920) emphasizing similar scalability of CTA311, highlighted results suggesting the therapeutic candidate has strong efficacy and favorable safety for R/R B-ALL patients. In a Phase 1 trial (NCT06307600), 11 patients with relapsed/refractory B-ALL received escalating doses (0.1–1.5M CAR+ T cells/kg) following standard lymphodepletion. CTA311 was well tolerated with no dose-limiting toxicities, neurotoxicity, or GvHD; cytokine release syndrome occurred in 54.5% (Grade 1–2 only). Robust CAR-T expansion and persistence were observed, with B-cell depletion aligning with expansion. Among 9 evaluable patients, 78% achieved CR/CRi/CRh, and 86% were MRD-negative. Median duration of remission was not reached at 12.8 months follow-up, with the longest ongoing remission at 16.4 months.
The final poster presented by Imviva (Abstract #4122) detailed a study in which researchers introduced Target Enrichment Long-range Sequencing (TELS), a novel method that significantly improves detection of structural variations (SVs) in genome-edited universal CAR-T cells compared to conventional PEM-seq. In head-to-head comparisons, TELS identified up to 196-fold more large deletions and 46-fold more translocations. TELS delivered precise quantification of editing efficiency and comprehensive SV profiling, ensuring more accurate safety assessments for CRISPR-engineered CAR-T products. These findings highlight TELS as a critical advancement for quality control in next-generation allogeneic CAR-T therapies.
“The encouraging results we’re seeing with CTA311 in relapsed/refractory B-ALL patients, combined with our innovative TELS technology, exemplify Imviva’s unwavering commitment to research-driven innovation,” said Imviva Biotech Chief Executive Officer Lu Han. “Our rigorous approach to both therapeutic development and manufacturing excellence ensures we can deliver safe, effective allogeneic CAR-T therapies to patients facing these devastating blood cancers. We’re building a foundation to address critical unmet medical needs with scalable, off-the-shelf solutions.”
Full abstract details can be found on the 2025 ASH Annual Meeting Abstracts website.
- Fattizzo, B., Rosa, J., Giannotta, J. A., Baldini, L., & Fracchiolla, N. S. (2020). The physiopathology of T-cell acute lymphoblastic leukemia: Focus on molecular aspects. Frontiers in Oncology, 10, 273. https://doi.org/10.3389/fonc.2020.00273
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).
About CTA311
CTA311 is an investigational ‘ready-at-point of care’ allogeneic anti-CD19 CAR-T cell therapy designed for B-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.
About Imviva Biotech
Imviva Biotech is a clinical-stage biotechnology company dedicated to developing innovative allogeneic CAR-T cell therapies for patients with cancer and autoimmune diseases. The company's proprietary platform incorporates advanced cell engineering technologies to create off-the-shelf cellular immunotherapies. Imviva’s pipeline includes programs in both oncology and autoimmune indications.
Bioheng Therapeutics has rebranded to Imviva Biotech, reflecting the Company’s global expansion.
Forward-Looking Statements
This press release contains forward-looking statements regarding product development and potential. These statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied.
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