KSX01 / TCRx Therap - LARVOL DELTA

Phase I trial of personalized AI-identified TCR-transduced T cell therapy in advanced solid tumors. (ASCO 2025) - P1 | "Patients received preconditioning with cyclophosphamide (500 mg/m²/day) and fludarabine (30 mg/m²/day) for 3 days, followed by intravenous infusion of KSX01 TCR-T cells at two dose levels (5×10⁹ ± 30% and 1×10¹⁰ ± 30% cells)...One patient developed Grade 2 CRS, resolved with tocilizumab... The first-in-human phase I trial of KSX01 TCR-T cell therapy demonstrated promising safety and efficacy in patients with advanced solid tumors. TCR-XFinder enabled rapid identification of personalized tumor-reactive TCRs, supporting the clinical feasibility of this approach. Further studies are warranted to explore optimal dosing and combination strategies to maximize clinical benefit."

Metastases • P1 data • Alveolar Soft Tissue Sarcoma • Clear Cell Renal Cell Carcinoma • Colon Cancer • Colorectal Cancer • Genito-urinary Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CRP • IFNG • IL10 • IL4 • IL6 • TNFA

A phase I study of personalized KSX01-TCRT therapy for advanced solid tumor and its mechanisms (ESMO 2024) - P1 | "AI-driven TCR identification as a promising method significantly shortens the drug manufacture time in personalized TCR T therapy. KSX01-TCRT is well tolerated and offers clinical benefits for multiple advanced solid tumors with no limit of HLA restriction or target expression."

IO biomarker • Metastases • P1 data • Oncology • Solid Tumor

Single Arm Clinical Study on the Safety and Efficacy of Personalized KSX01-TCRT in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Metastases • New P1 trial • Oncology • Solid Tumor

KSX01-TCRT Injection Project in Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: TCRx Therapeutics Co.Ltd

New P1 trial • Oncology • Solid Tumor