protocolSection identificationModule nctId: NCT06281847, orgStudyIdInfo id: CCTx-001-AML-001, briefTitle: 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, acronym: RESOLVE AML001, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2041-08, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Advesya SAS, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Acute Myeloid Leukemia, in Relapse, conditions: Acute Myeloid Leukemia Refractory, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study comprises 4 periods:* The pre-treatment period will consist of screening for eligibility, leukapheresis and a pre-treatment evaluation (prior to Lymphodepleting Chemotherapy (LDC)).* The treatment period will start with LDC, followed by CCTx-001 infusion 2 to 7 days after completion of LDC. A first response evaluation will be performed at approximately 28 days after CCTx-001 infusion.* The post-treatment period will consist of further clinical activity and safety follow-up visits at regular timepoints after CCTx-001 infusion, starting after the Month 3 visit up to the Month 24 visit.* The long-term follow-up period will start after the Month 24 visit up to 15 years post CCTx-001 infusion., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 143, type: ESTIMATED, armsInterventionsModule interventions name: CCTx-001, outcomesModule primaryOutcomes measure: Phase 1: To evaluate the safety, tolerability, and to define the recommended phase 2 dose (RP2D) of CCTx-001, primaryOutcomes measure: Phase 2: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001, secondaryOutcomes measure: Phase 2: To evaluate the clinical activity, as assessed by the complete remission rate, in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001, secondaryOutcomes measure: Phase 2: To assess the safety of CCTx-001, secondaryOutcomes measure: Phase 2: To assess HRQoL for patients treated with CCTx-001, secondaryOutcomes measure: Phase 2: To assess HRQoL for patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To evaluate the overall safety and the tolerability of CCTx-001, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Besançon Regional and University Hospital, city: Besançon Cedex, country: France, contacts name: Eric Deconinck, role: CONTACT, contacts name: Eric Deconinck, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.24878, lon: 6.01815, locations facility: Hospital Saint Louis, city: Paris, country: France, contacts name: Nicolas Boissel, role: CONTACT, contacts name: Nicolas Boissel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Ludwig-Maximilians University of Munich, city: Munich, country: Germany, contacts name: Marion Subklewe, role: CONTACT, contacts name: Marion Subklewe, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.13743, lon: 11.57549, locations facility: University Hospital Ulm, city: Ulm, country: Germany, contacts name: Elisa Sala, role: CONTACT, contacts name: Elisa Sala, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.39841, lon: 9.99155, locations facility: Vall d'Hebron University Hospital, city: Barcelona, country: Spain, contacts name: Pere Barba, role: CONTACT, contacts name: Pere Barba, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Karolinska University Hospital, city: Stockholm, country: Sweden, contacts name: Stephan Mielke, role: CONTACT, contacts name: Stephan Mielke, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False