Acute Myeloid Leukemia, in RelapsePhase 1/2RESOLVE AML001NCT06281847
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
A Phase 1/2 study testing CCTx-001 in people with Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, run by Advesya SAS at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
- What is being tested?
- CCTx-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Dec 2025to Aug 2041
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with active (> 5 % blasts in bone marrow) r/r AML (WHO 2022) who have exhausted their therapeutic alternatives or have contraindications to these alternatives as judged by the treating physician defined as either:
- Primary refractory: i. Patients who failed after two cycles of intensive induction including high-dose and/or standard dose cytarabine (including liposomal formulation), +/- anthracycline, +/- antimetabolite, +/- targeted therapy or ii. Older patients or patients unfit to receive intensive induction courses who failed after two cycles of venetoclax + azacitidine or 4 cycles of azacitidine b. Relapsing: i. Patients with early relapse after CR to first line therapy (within ≤ 6 months after CR1) or ii. Patients with relapse after later lines of therapy (Relapse after CR≥2) c. Patients relapsing after allogeneic hematopoietic stem cell transplant: i. Patients must be at least 3 months from hematopoietic stem cell transplant (HSCT) at the time of consent, and ii. Off immunosuppression for at least 1 month at the time of consent, and iii. Have no active graft versus host disease (GvHD)
- Have a circulating blast count of less than 20,000/mm3 (control with hydroxyurea is allowed)
- Absolute Lymphocyte count of >200/mm3
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Life expectancy of more than 3 months
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- Patient is ≥ 18 years of age at the time of informed consent
- Read, understood, and signed the informed consent form (ICF) prior to any study procedures
- Patient is willing and able to adhere to the study visit schedule and other protocol requirements
- Eligible for leukapheresis
- Treatment-related toxicities of previous therapies have completely resolved
- Adequate organ function as confirmed by clinical laboratory values, defined as:
- Adequate bone marrow function to receive LDC as assessed by the Investigator
- Serum creatinine [< 1.5 x the upper limit of normal (ULN) or creatinine clearance (CrCl) > 45 mL/min] (estimated by Cockcroft Gault or Modification of Diet in Renal Disease (MDRD); see Appendix 14.3 for calculation)
- Alanine aminotransferase [≤ 3 x ULN and total bilirubin < 1.5 mg/dL (or < 3.0 mg/dL] for patients with Gilbert's syndrome or leukemic infiltration of the liver)]
- Adequate pulmonary function, defined as [≤ Grade 1 dyspnoea according to CTCAE and oxygen saturation (SaO2) ≥ 92% on room air and forced expiratory volume in the first second ≥ 50%]
- Ejection fraction > 40% assessed by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed within 1 month before CCTx-001 infusion
- Women of childbearing potential* (WOCBP) must have a negative serum pregnancy test performed at screening and within 7 days before enrolment
- WOCBP or males whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception during the study and for 12 months after the last dose of LDC. For the definition and list of highly effective methods of contraception.
Who cannot join
- Patients with an acute promyelocytic leukaemia: t(15;17)(q22;q12); (promyelocytic leukaemia/retinoic acid receptor alpha) and variants
- Patients with active central nervous system (CNS) leukaemia involvement. If the patient has prior history of CNS leukaemia, they must have a negative cerebrospinal fluid (CSF) assessment and magnetic resonance imaging (MRI) or computed tomography (if MRI is not feasible) of the brain demonstrating no evidence of CNS disease
- Patients with isolated extramedullary AML disease
- Patients who received previous treatment targeting IL-1RAP or previous gene therapy
- Patients who underwent allo-HSCT within 90 days prior to leukapheresis
- Patients who received donor lymphocyte infusion within 60 days prior to leukapheresis
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- Patients with active GvHD
- Patients with history of another primary malignancy other than disease under study unless the patient has been free of the disease for ≥ 2 years, except for the following non-invasive malignancies:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (T1a or T1b) or prostate cancer that is curative
- Other completely resected stage 1 solid tumour with low risk for recurrence
- Presence of systemic fungal, bacterial, viral, or other infection (including tuberculosis) that is uncontrolled despite appropriate antibiotics or other treatments
- Active or prior history of hepatitis B or hepatitis C infection
- History of or active human immunodeficiency virus (HIV) infection
- Active macrophage activation syndrome (MAS) as evidenced by laboratory abnormalities (e.g.: elevated ferritin, elevated triglycerides, haemophagocytosis on the bone marrow sample) and/or clinical signs
- History or presence of an active and clinically relevant CNS disorder such as epilepsy, generalised seizure disorder, paresis, aphasia, stroke, cerebral oedema, severe brain injury, dementia, multiple sclerosis, Parkinson's disease, cerebellar disease, organic brain syndrome, or posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement
- Patients with active autoimmune disorders or active neurological or inflammatory disorders (e.g., Guillain-Barre Syndrome, Amyotrophic Lateral Sclerosis) requiring immunosuppressive therapy or corticosteroid therapy (defined as >20 mg/day prednisone or equivalent). Physiologic replacement, topical, and inhaled steroids are permitted.
- Use of the following (see Section 8.3 for full details):
- Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis or 72 hours prior to CCTx-001 infusion. Physiologic replacement, topical, and inhaled steroids are permitted.
- Immunosuppressive therapies within 4 weeks prior to signing the ICF (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-tumour necrosis factor [TNF], anti-IL-6, or anti-IL-6 receptor [IL-6R])
- Cytotoxic chemotherapeutic agents (including intrathecal) within 14 days prior to leukapheresis.
- Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
- Experimental agents within 4 weeks prior to signing the ICF unless no response or progressive disease (PD) is documented on the experimental therapy and at least 3 half-lives have elapsed prior to signing the ICF.
- Therapeutic anticoagulation
- History of any one of the following cardiovascular conditions within the past 6 months prior to signing the ICF:
- Class III or IV heart failure as defined by the New York Heart Association
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Other clinically significant cardiac disease
- Known hypersensitivity to DMSO or other excipients
- Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or unwillingness or inability to follow the procedures required in the protocol.
- Abnormal findings and/or clinically significant Grade ≥3 non-haematological toxicity and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient's safety.
- Presence of any condition that confounds the ability to interpret data from the study based on Investigator´s judgement.
- Any planned medical/surgical treatment that might interfere with the ability to comply with the study requirements.
- Pregnant or nursing women. NOTE: WOCBP must have a negative serum pregnancy test performed within 48 hours of starting LDC
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
France2 sites
Besançon Regional and University Hospital
Besançon
Eric Deconinck
Eric Deconinck
Hospital Saint Louis
Paris
Nicolas Boissel
Nicolas Boissel
Germany2 sites
Ludwig-Maximilians University of Munich
Munich
Marion Subklewe
Marion Subklewe
University Hospital Ulm
Ulm
Elisa Sala
Elisa Sala
Sweden1 site
Karolinska University Hospital
Stockholm
Stephan Mielke
Stephan Mielke
About this study
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.
- Being tested
- CCTx-001
- Keywords
- Acute Myeloid Leukemia, Relapsed, Refractory, Open-label, Safety, Tolerability
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTx-001Genetic
Frozen CAR T-cells suspensions in media containing dimethyl sulfoxide (DMSO)
| Study group | Role | What they receive |
|---|---|---|
| Open Label CCTx-001 infusion | Experimental | CCTx-001 infusion 2 to 7 days after completion of LDC Receives: Genetic: CCTx-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: To evaluate the safety, tolerability, and to define the recommended phase 2 dose (RP2D) of CCTx-001
Frequency, severity, relationship and persistence of adverse events (AEs) and dose-limiting toxicity (DLTs)
Measured: Up to 28 days
Phase 2: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001
Composite complete response rate (cCRR) defined as the proportion of patients with best overall response, as assessed by Independent Review Committee (IRC) based on European LeukemiaNet (ELN) 2022 criteria, at complete remission (CR), CR with partial haematologic recovery (CRh), or CR with incomplete haematologic recovery (CRi).
Measured: Up to 3 months
Secondary outcomes (13)
Phase 2: To evaluate the clinical activity, as assessed by the complete remission rate, in patients treated with CCTx-001
Complete remission rate (CRR) defined as the proportion of patients with best overall response, as assessed by IRC based on ELN 2022 criteria, at CR.
Measured: Up to 3 months
Phase 1: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001
cCRR
Measured: Up to 3 months
Phase 2: To assess the safety of CCTx-001
Frequency, severity, relationship and persistence of AEs
Measured: Up to 15 years
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
Objective response rate (ORR)
Measured: Up to 3 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
event-free survival (EFS)
Measured: Up to 24 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
relapse-free survival (RFS)
Measured: Up to 24 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
overall survival (OS)
Measured: Up to 15 years
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
duration of response (DOR)
Measured: Up to 24 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
cumulative incidence of relapse (CIR)
Measured: Up to 24 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
cumulative incidence of death (CID)
Measured: Up to 24 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
time to composite complete response (TTcCR)
Measured: Up to 24 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
time to response (TTR) according to ELN 2022 criteria and minimal residual disease (MRD) responses
Measured: Up to 3 months
Phase 1 & 2: To evaluate the overall safety and the tolerability of CCTx-001
Frequency and severity of AEs and laboratory abnormalities
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study startDec 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, in RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advesya SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281847
- Sponsor's protocol ID
- CCTx-001-AML-001
- Acronym
- RESOLVE AML001
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT06281847
- Acronym / sponsor ID
- RESOLVE AML001 / CCTx-001-AML-001
- Keywords
- Acute Myeloid Leukemia, Relapsed, Refractory, Open-label, Safety, Tolerability
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Advesya SASIndustry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2041 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open Label CCTx-001 infusion | Experimental | Genetic: CCTx-001CCTx-001 infusion 2 to 7 days after completion of LDC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients with active (> 5 % blasts in bone marrow) r/r AML (WHO 2022) who have exhausted their therapeutic alternatives or have contraindications to these alternatives as judged by the treating physician defined as either:
- Have a circulating blast count of less than 20,000/mm3 (control with hydroxyurea is allowed)
- Absolute Lymphocyte count of >200/mm3
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Life expectancy of more than 3 months
Key exclusion criteria (39 listed)
- Patients with an acute promyelocytic leukaemia: t(15;17)(q22;q12); (promyelocytic leukaemia/retinoic acid receptor alpha) and variants
- Patients with active central nervous system (CNS) leukaemia involvement. If the patient has prior history of CNS leukaemia, they must have a negative cerebrospinal fluid (CSF) assessment and magnetic resonance imaging (MRI) or computed tomography (if MRI is not feasible) of the brain demonstrating no evidence of CNS disease
- Patients with isolated extramedullary AML disease
- Patients who received previous treatment targeting IL-1RAP or previous gene therapy
- Patients who underwent allo-HSCT within 90 days prior to leukapheresis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTx-001Frozen CAR T-cells suspensions in media containing dimethyl sulfoxide (DMSO) | Genetic | Open Label CCTx-001 infusion |
Primary outcome
Phase 1: To evaluate the safety, tolerability, and to define the recommended phase 2 dose (RP2D) of CCTx-001
Time frame: Up to 28 days
Frequency, severity, relationship and persistence of adverse events (AEs) and dose-limiting toxicity (DLTs)
Phase 2: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001
Time frame: Up to 3 months
Composite complete response rate (cCRR) defined as the proportion of patients with best overall response, as assessed by Independent Review Committee (IRC) based on European LeukemiaNet (ELN) 2022 criteria, at complete remission (CR), CR with partial haematologic recovery (CRh), or CR with incomplete haematologic recovery (CRi).
13 secondary outcomes
Phase 2: To evaluate the clinical activity, as assessed by the complete remission rate, in patients treated with CCTx-001
Time frame: Up to 3 months
Phase 1: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001
Time frame: Up to 3 months
Phase 2: To assess the safety of CCTx-001
Time frame: Up to 15 years
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
Time frame: Up to 3 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
Time frame: Up to 24 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
Time frame: Up to 24 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
Time frame: Up to 15 years
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
Time frame: Up to 24 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
Time frame: Up to 24 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
Time frame: Up to 24 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
Time frame: Up to 24 months
Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001
Time frame: Up to 3 months
Phase 1 & 2: To evaluate the overall safety and the tolerability of CCTx-001
Time frame: Up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CCTx-001 in people with Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, run by Advesya SAS at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Germany, Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: To evaluate the safety, tolerability, and to define the recommended phase 2 dose (RP2D) of CCTx-001 (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.