NCT06281847

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

Study Summary

The purpose of this adaptive Phase 1/2 study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antileukemic activity of CCTx-001 in adult patients with r/r Acute Myeloid Leukemia (AML). CCTx-001 targets IL-1RAP, which is specifically expressed in leukemic cells. In preclinical studies, IL-1RAP-targeted Chimeric antigen receptors (CARs) have demonstrated encouraging activity in both in vitro and in vivo experiments in AML models. Based on these promising preclinical results, it is expected that CCTx-001 could potentially alter the natural course of r/r AML and provide a potential novel treatment option.

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Interventions

CCTx-001GENETIC
Frozen CAR T-cells suspensions in media containing dimethyl sulfoxide (DMSO)

Study Locations

FacilityCityStateCountry
Besançon Regional and University HospitalBesançonFrance
Hospital Saint LouisParisFrance
Ludwig-Maximilians University of MunichMunichGermany
University Hospital UlmUlmGermany
Vall d'Hebron University HospitalBarcelonaSpain
Karolinska University HospitalStockholmSweden

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026