CCTx-001 / Advesya - LARVOL DELTA

IL-1RAP Is a Targetable Surface Antigen in Relapsed/Refractoy AML (ASH 2024) - P, P1/2 | "Most (79%) had been previously exposed to intensive Cx, 58% to venetoclax and 21% had a previous allo-HCT. This data supports the use of IL-1RAP as a target antigen in R/R AMLs. The safety and clinical activity of the first in class, 3rd generation autologous IL-1RAP-directed CAR T cell therapy (CCTx-001) will be tested in the RESOLVE AML-001 study (NCT06281847)."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD34 • FLT3 • HAVCR2 • IDH1 • IDH2 • NPM1

Resolve AML 001: An Adaptive Open-Label Multicentre Phase 1/2 Trial, to Determine the Recommended Phase 2 Dose of Cctx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients with r/r AML (ASH 2024) - "Patients will receive the assigned dose of CCTx-001 after lymphodepletion (LDC) with fludarabine IV (4D 30 mg/m2) and cyclophosphamide IV (3D 300 mg/m2). The trial received EU CTIS approval in July 2024. Clinical trial information : CTIS 2023-506865-71-00"

Clinical • P1/2 data • P2 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • IL1RAP • IL33

CCTX-001, A FIRST IN CLASS AUTOLOGOUS ANTI-IL-1RAP CAR T-CELL THERAPY FOR THE TREATMENT OF RELAPSED/REFRACTORY AML (EHA 2024) - P1/2 | "Background: Relapsed/refractory acute myeloid leukaemia (r/r AML) poses significant therapeutic challenges, necessitatingnovel treatment strategies. CCTx-001 is a potential promising therapy for relapsed/refractory AML, offering targeted and effectivetreatment options for patients in need. Based on this data, the RESOLVE AML 001 study (NCT06281847) isbeing conducted. This study is a seamless adaptive Phase 1/2 trial evaluating CCTx-001 in adult patients withr/r AML across 4 dose levels (0."

CAR T-Cell Therapy • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation • IL1R1 • IL1RAP

CCTx-001 CAR T-cells targeting the AML specific antigen IL-1RAP show robust pre-clinical anti-tumor efficacy (AACR 2024) - "The promising preclinical data presented herein warrant the evaluation of CCTx-001 CAR T-cell therapy in clinical trials for r/r AML patients. CCTx-001 CAR T-cell therapy offers a potential breakthrough in addressing the unmet medical needs of AML patients with resistant or refractory disease."

CAR T-Cell Therapy • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD34 • CD8

RESOLVE AML001: An Adaptive Open-label Multicentre Phase 1/2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed/Refractory Acute Myeloid Leukaemia (clinicaltrials.gov) - P1/2 | N=143 | Not yet recruiting | Sponsor: Advesya SAS

New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology