Imviva Biotech Reports Promising CAR-T Cell Therapy Data at ASH 2025 Meeting
核心洞察
Imviva Biotech (搜索) presented data on two allogeneic CAR-T cell therapies, CTD402 and CTA311, at the 67th American Society of Hematology Annual Meeting.
CTD402 demonstrated high MRD-negative remission rates in T-cell acute lymphoblastic leukemia (搜索) patients and showed potential for treating severe aplastic anemia (搜索).
CTA311 achieved 78% complete remission rates in relapsed/refractory B-cell acute lymphoblastic leukemia (搜索) patients with favorable safety profile.
Imviva Biotech (搜索) presented encouraging clinical data for its allogeneic CAR-T cell therapies CTD402 and CTA311 in five poster presentations at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. The data demonstrate the potential of these off-the-shelf cellular therapies to address challenging hematological malignancies with limited treatment options.
CTD402 Shows Promise in T-Cell Malignancies
The company's investigational CD7 (搜索)-targeted allogeneic CAR-T therapy CTD402 is being evaluated in the ongoing Phase 1b/2 TENACITY-01 clinical trial for relapsed/refractory T-cell acute lymphoblastic leukemia (搜索) and lymphoblastic lymphoma (搜索) (T-ALL/LBL). The global, single-arm, open-label trial is enrolling adolescents and adults (≥12 years) to evaluate safety, efficacy, and cellular pharmacokinetics.
The study design includes Phase 1b dose determination in approximately 18 patients, followed by Phase 2 enrollment of approximately 36 patients. All participants receive standard dose lymphodepletion with fludarabine and cyclophosphamide, followed by a flat dose of 400×10⁶ CTD402 CAR-T cells. Primary endpoints include incidence of dose-limiting toxicities and overall complete remission rate.
"About 20% of children and 40% of adults with T-ALL/LBL relapse after first-line therapy, leaving few options and high mortality," said Imviva Biotech (搜索) 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."
Preliminary data from earlier studies suggest CTD402 achieves high MRD-negative remission rates and durable responses, supporting its potential as a transformative therapy for relapsed/refractory T-ALL/LBL.
Expanding Applications to Severe Aplastic Anemia
CTD402 is also being investigated for severe aplastic anemia (搜索) (SAA), a life-threatening bone marrow failure disorder driven by aberrant T-cell activity. The ongoing Phase I trial uses a single-arm, open-label, 3+3 dose-escalation design to evaluate safety, tolerability, and determine the maximum tolerated dose in adults with relapsed/refractory SAA.
Secondary objectives include hematologic response rates at 3 and 6 months, duration of response, and pharmacokinetics, with exploratory endpoints assessing immune reconstitution biomarkers. This study aims to establish CTD402 as a first-in-class cellular therapy for SAA, addressing an area with limited treatment options for patients unresponsive to immunosuppressive therapy.
CTA311 Demonstrates Efficacy in B-Cell Leukemia
The company's allogeneic CD19 (搜索)-targeted CAR-T therapy CTA311 showed strong efficacy and favorable safety in relapsed/refractory B-cell acute lymphoblastic leukemia (搜索) (B-ALL) patients. In a Phase 1 trial, 11 patients 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 graft-versus-host disease. Cytokine release syndrome occurred in 54.5% of patients, with only Grade 1–2 severity observed. Among 9 evaluable patients, 78% achieved complete remission (CR/CRi/CRh), and 86% were MRD-negative. The median duration of remission was not reached at 12.8 months follow-up, with the longest ongoing remission at 16.4 months.
Manufacturing Innovation and Quality Control
Imviva's standardized manufacturing process demonstrated effectiveness in mitigating donor and lot variability while delivering consistent clinical outcomes. Analysis of 18 production lots from 13 donors and 64 patients with relapsed/refractory 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.
The company also introduced Target Enrichment Long-range Sequencing (TELS), a novel method that significantly improves detection of structural variations 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, delivering precise quantification of editing efficiency and comprehensive structural variation profiling.
Regulatory Recognition and Future Outlook
CTD402 has received Rare Pediatric Disease Designation and Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (搜索). Both CTD402 and CTA311 incorporate T-cell receptor and HLA knockout, along with Imviva's proprietary ANSWER™ inhibitory ligands to enhance resistance to host immune rejection.
"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 (搜索) 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."