UHKT-CAR19 / Institute of Hematology and Blood Transfusion - LARVOL DELTA

Phase I Evaluation of piggyBac-Engineered CD19 CAR T Cells with an Enhanced Tscm Profile for Refractory B-cell Malignancies (EHA-EBMT-CART 2026) - P1 | "Patients received fludarabine (25 mg/m²/day ×5) and cyclophosphamide (500 mg/m²/day ×2) followed by a single CAR-T infusion at 0.5×10⁶ or 1×10⁶ CAR⁺ cells/kg, with 0.1–0.4×10⁶ CAR⁺ cells/kg administered in cases of insufficient expansion...For comparison, tisa-cel (n=15) and axi-cel (n=8) cohorts were analyzed to assess differences in product phenotype. Results : Compared with tisa-cel, UHKT CAR19 product contained higher numbers of Tscm and CD27 + CD28 + cells in both CD4⁺ and CD8⁺ populations and a higher percentage of PD-1 – cells...These preliminary results justify continued evaluation, and enrollment in the high-dose cohort is ongoing. Clinical Trial Registry : NCT05054257"

CAR T-Cell Therapy • First-in-human • P1 data • Oncology • CD27 • CD4 • CD8 • IL21 • PD-1

UHKT-CAR19-01: CART19 Cells Effects in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Institute of Hematology and Blood Transfusion, Czech Republic | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

POINT-OF-CARE NON-VIRAL PRODUCTION OF CD19 CHIMERIC ANTIGEN RECEPTOR-T CELLS WITH ENHANCED TSCM IMMUNOPHENOTYPE FOR THERAPY OF REFRACTORY B-CELL MALIGNANCIES- PRELIMINARY RESULTS OF PHASE I CLINICAL TRIAL (EHA 2024) - P1 | "This phase I trial uses a dose-escalating scheme, where all patients receive 25 mg/m2/d offludarabine for 5 days and 500 mg/m 2/d of cyclophosphamide for 2 days followed by a single infusion ofUHKT CAR19...The UHKT CAR19 displayed a higher percentageof stem-cell memory CAR-T cells compared to with tisa-cel, in both CD4+ and CD8+ CAR+ T cells... Infusion of UHKT CAR19 was safe and we observed clinical anti-tumor effects in seven out of eleven patients sofar included in the trial. The manufacturing method enables efficient point-of-care production of CAR-T cellswith stem-cell memory phenotype. We are enrolling patients in the high-dose group for the clinical trial."

CAR T-Cell Therapy • Clinical • P1 data • Gene Therapies • CD27 • CD8 • PD-1

UHKT-CAR19-01: CART19 Cells Effects in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Institute of Hematology and Blood Transfusion, Czech Republic | Trial completion date: Jun 2028 ➔ Jun 2025 | Trial primary completion date: Jun 2027 ➔ Dec 2024

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19