Acute Myeloid LeukemiaPhase 1/2NCT06508489
A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies
A Phase 1/2 study testing SAR443579, venetoclax and azacitidine in people with Acute Myeloid Leukemia, run by Sanofi at 7 sites in 2 countries.
Trial summary
This was a parallel, Phase 1/Phase 2, randomized, open label, multi-cohort, multi-center study assessing the safety, tolerability and preliminary efficacy of SAR443579 with different agents for treatment in adolescent and/or adult participants with CD123 expressing hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- SAR443579, venetoclax and azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 13 Aug 2024to 8 Aug 2025
- Phase
- Phase 1/2
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
- Participants with CD123-expressing hematological neoplasm per the 5th edition of the WHO Classification of Hematolymphoid Tumors.
- Substudy 01:
- Participants must be ≥18 years of age
- Confirmed diagnosis of Acute Myeloid Leukemia
- Ineligible for intensive chemotherapy. Ineligible for intensive chemotherapy was defined by the following criteria:
- ≥ 75 years of age, OR
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- 18 to 74 years of age and meeting one or more of the following:
- Eastern Cooperative Oncology Group (ECOG) performance status 2-3.
- Cardiac history of congestive heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) ≤50% or symptomatic coronary heart disease confirmed by coronarography or cardiac imaging.
- Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤65% or forced expiratory volume (FEV1) ≤65%.
- Creatinine clearance ≥30 to <45 mL/min calculated by modification of diet in renal disease (MDRD) formula.
- Moderate hepatic impairment with total bilirubin >1.5 to ≤3.0x upper limit of normal (ULN).
- Participant with an Eastern Cooperative Oncology Group (ECOG) performance status as follows:
- 0 to 2 for participants ≥75 years of age or b) 0 to 3 for participants 18 to 74 years of age.
- For participants ≥75 years of age, adequate renal function demonstrated by a creatinine clearance ≥30 mL/min, calculated by modification of diet in renal disease (MDRD)
- Participant with adequate liver function demonstrated by the following:
- For participants 18 to 74 years of age, aspartate aminotransferase (AST) ≤3.0 × ULN, alanine aminotransferase (ALT) ≤3.0 × ULN and bilirubin ≤3.0 × ULN, unless considered due to leukemic organ involvement ˂5 × ULN.
- For participants ≥75 years of age, aspartate aminotransferase (AST) ≤3.0 × ULN, alanine aminotransferase (ALT) ≤3.0 × ULN and bilirubin ≤1.5 × ULN, unless considered due to leukemic organ involvement ˂5 × ULN.
Who cannot join
- Any clinically significant, uncontrolled medical conditions (including any serious active systemic infection that was not controlled)
- Known second malignancy either progressing or requiring active treatment within the last 3 years prior to first IMP administration
- Known acquired immunodeficiency syndrome (AIDS-related illnesses) or HIV disease requiring antiretroviral treatment, or having active hepatitis B or C infection, or SARS-CoV-2 infection. With exception for:
- HBV as determined by positive test for hepatitis B surface antigen (HBsAg) and/or HBV DNA. Participant who tested positive for anti-hepatitis B core (HBc) antigen IgG (with or without testing positive for anti-HBs), but tested negative for HBsAg and HBV DNA, was eligible.
- A participant who tested positive for anti-HCV antibodies and had undetectable HCV RNA without receiving antiviral treatment for HCV was eligible.
- Active, known, or suspected clinically significant autoimmune disease that had required systemic treatment in the past 2 years prior to first IMP administration, except controlled by replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc)
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- Predicted life expectancy ≤3 months.
- Medical conditions requiring treatment with medications with narrow therapeutic index that were substrates of CYP enzymes and that could not be closely monitored to allow for dose adjustment.
- Ongoing adverse event of NCI CTCAE [Version 5.0] Grade 2 or greater severity cause by any prior anti-cancer therapy
- Substudy 01:
- Patient with Acute Promyelocytic Leukemia (APL)
- Known active central nervous system involvement with AML at the time of enrollment as evidenced by cytology or pathology
- Cardiovascular disease of New York Heart Association (NYHA) Class ≥2.
- Malabsorption syndrome or other condition that precludes enteral route of administration
- A baseline QTc interval of (using the Fridericia correction calculation) >470 msec.
- Participant had received treatment with at least one of the following:
- A hypomethylating agent, venetoclax and/or chemo therapeutic agent for AML other than hydroxyurea used for disease control prior to the initiation of study therapy.
- Experimental therapies for AML.
- Concomitant medications of strong and moderate CYP3A inducers within 7 days prior to the initiation of study treatment.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
The Ohio State University Wexner Medical Center - Ohio State Outpatient Care Upper Arlington- Site Number : 8400001
Columbus, Ohio, 43221
City of Hope National Medical Center- Site Number : 8400003
Duarte, California, 91010
The University of Texas MD Anderson Cancer Center- Site Number : 8400008
Houston, Texas, 77030
Oregon Health and Science University- Site Number : 8400006
Portland, Oregon, 97239
Montefiore Medical Center - Moses Campus- Site Number : 8400004
The Bronx, New York, 10467
Australia2 sites
Investigational Site Number : 0360001
Melbourne, Victoria, 3000
Investigational Site Number : 0360002
Wollongong, New South Wales, 2500
About this study
Official title: A Phase 1/Phase 2, Randomized, Open-label, Multi Cohort, Multi Center, Study Assessing the Safety, Tolerability and Preliminary Efficacy of SAR443579 a Natural Killer Cell Engager (NKCE) Targeting CD123, Administered With Different Agents in Participants With CD123 Expressing Hematological Malignancies
This was a parallel, Phase 1/Phase 2, randomized, open label, multi-cohort, multi-center study assessing the safety, tolerability and preliminary efficacy of SAR443579 with different agents for treatment in adolescent and/or adult participants with CD123 expressing hematological malignancies.
This protocol was structured as a master protocol (containing common protocol elements). Individual sub-studies would explore SAR443579 with combination partners, which might include approved or investigational agents.
Read more
Experimental sub-studies would be tested through 3 parts:
Part 1: dose finding (such as dose escalation/ safety run-in). Part 2: dose optimization (when applicable). Part 3: dose expansion. In each sub-study, a dose escalation would identify preliminary recommended dose for expansion (pRDE) of SAR443579 and its respective combination partner. Following the determination of the preliminary RDE, additional participants would be enrolled in the dose expansion part, or if dose optimization needs to be further evaluated, additional participants would be enrolled in the "dose optimization/expansion" part. Dose optimization and dose expansion part could involve randomization depending on specific sub-study design.
Study consisted of a screening period, treatment period, and follow-up period. Participants would receive study treatment until documented disease progression, unacceptable adverse events, participant's decision to stop study treatment, or completion of the maximum cycles allowed in the sub-studies, or the participant met other criteria for discontinuation per study protocol (whichever occurred first).
Read the detailed description
Substudy 01:
Title: A Phase 1/Phase 2, open-label, multi-center study, assessing the safety, tolerability and the preliminary efficacy of SAR443579 administered in combination with azacitidine + venetoclax in adult participants with CD123 expressing newly diagnosed Acute Myeloid Leukemia (ND-AML) that are ineligible for intensive chemotherapy
Short title: A study to investigate natural killer cell engager (SAR443579) in combination with azacitidine + venetoclax in adult participants with newly diagnosed acute myeloid leukemia
The expected duration of the study for a participant was approximately about 2.5 years. The study duration includes a screening period, an induction and maintenance. After the end of study treatment participants would enter the follow-up period for up to 2 years.
Planned number of participants:
22 participants planned to be screened, 8 being adults and 14 being elderly; 9-18 participants planned to be enrolled (dose escalation part)
Enrollment would be paused upon completion of Part 1: Dose Escalation. The available data would be reviewed and the recommended doses and schedule for optimization would be selected by the study board. Enrollment in the Part 2: Dose optimization and Part 3: Dose expansion would be provided in a future protocol amendment.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- SAR443579, venetoclax, azacitidine
- Keywords
- AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR443579Biological
Pharmaceutical form: Powder for solution for infusion Route of administration: intravenous infusion
venetoclaxDrug
Also called VENCLYXTO / VENCLEXTA
Pharmaceutical form :Film coated tablet Route of administration: oral
azacitidineDrug
Pharmaceutical form: Lyophilized powder for suspension for injection Route of administration: intravenous or subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Substudy 01: SAR443579 + azacitidine + venetoclax | Experimental | Part 1: Safety run-in: SAR443579 treatment will begin with an identified starting dose. Safety run-in will proceed according to the incidence of DLTs. Receives: Biological: SAR443579; Drug: venetoclax; Drug: azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub-study 1: Part 1: Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT=any of the following events during Cycle 1 (first 28 days) using NCI CTCAE v5.0 or ASTCT criteria, whether related or not to study treatment in absence of clear evidence to the contrary, and if not related to disease progression. Hematologic DLTs :toxicities, bone marrow hypocellularity, decreased neutrophils, febrile neutropenia, decreased platelets, anemia (all Grade 4) and Grade 3 thrombocytopenia. Non-hematologic DLTs: organ toxicities or infusion reaction (both Grade 4), Grade 3 infusion reaction lasting >24 hours, Hy's law cases, Grade 3-4 infection, Grade 3 electrolyte abnormalities or transaminitis elevation, Grade >=3 toxicities except alopecia, Grade 3 fatigue, asthenia, fever, anorexia, constipation, nausea, vomiting, diarrhea, infection, bleeding, Grade 3 cytokine release syndrome or laboratory abnormalities, Grade 3 or 4 tumor lysis syndrome. Any treatment related toxicity causing >2-week delay in recovery to baseline/Grade <=1 or requiring dose reduction/withdrawal.
Measured: From Day 1 to Day 28 of Cycle 1 (each cycle was 28 days)
Sub-study 1: Part 2: Dose Optimization: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events of Special Interest (AESIs)
An AE was any untoward medical occurrence in participant or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any AE, that at any dose: resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. The TEAEs were defined as AEs that developed, worsened or became serious after the first administration of study treatment up to 30 days after the last administration of study treatment.
Measured: AEs were planned to be collected from first dose of study treatment (Day 1) up to 30 days post last dose of study treatment
Sub-study 1: Part 2: Dose Optimization: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Blood samples were planned to be collected to determine the PCSA in hematology.
Measured: Planned to be collected from first dose of study treatment (Day 1) up to 30 days post last dose of study treatment
Sub-study 1: Part 2: Dose Optimization: Number of Participants With Potentially Clinically Significant Abnormalities in Clinical Chemistry Parameters
Blood samples were planned to be collected to determine the PCSA in clinical chemistry.
Measured: Planned to be collected from first dose of study treatment (Day 1) up to 30 days post last dose of study treatment
Sub-study 1: Part 2: Dose Optimization: Complete Remission (CR) Rate
The CR rate was defined as percentage of participants who had a CR determined by the Investigator according to 2022European Leukemia Net (ELN) recommendations for diagnosis and management of AML.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenancecycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause,whichever occurred first
Sub-study 1: Part 3: Dose Expansion: Complete Remission (CR) Rate
The CR rate was defined as percentage of participants who had a CR determined by the Investigator according to 2022 European Leukemia Net (ELN) recommendations for diagnosis and management of AML.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Secondary outcomes (20)
Sub-study 1: Part 1: Dose Escalation and Part 3: Dose Expansion: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), TE Serious Adverse Events (TESAEs) and TE Adverse Events of Special Interest (TEAESIs)
An AE was any untoward medical occurrence in participant or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any AE, that at any dose: resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. TEAEs: AEs that developed, worsened/became serious after first administration of study treatment up to 30 days after last administration of study treatment.
Measured: From the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 31.3 weeks
Sub-study 1: Part 3: Dose Expansion: Percentage of Participants With Minimal Residual Disease
The minimal residual disease rate was defined as the percentage of participants with minimal residual disease as defined by 2022 ELN in participants achieving a CR, CR with partial hematologic recovery (CRh) or CR with incomplete hematologic recovery (CRi).
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Sub-study 1: All 3 Parts: Concentrations Observed at the End of Dosing Period During Repeated Administration (Ctrough) of SAR443579
Blood samples were collected just before treatment administration during repeated dosing to determine the Ctrough of SAR443579 during dose escalation part. Participants missed few scheduled site visits for sample collection and only participants with data collected at specified timepoints are reported.
Measured: Part 1:Dose escalation (dose levels 1 and 2): Pre-dose: At Days 1, 8, 15 and 22 of Cycle 1 and Days 8, 15, 22 and 28 of Cycle 2 (each cycle was 28 days)
Sub-study 1: All 3 Parts: Maximum Plasma Concentration Observed (Cmax) of Venetoclax
Blood samples were collected at specified timepoints to determine Cmax of venetoclax during dose escalation part. Participants missed few scheduled site visits for sample collection and only participants with data collected at specified timepoints are reported.
Measured: Part 1:Dose escalation (dose levels 1 and 2):Pre-dose and 2, 3, 4, 6, 11 and 24 hours post-dose on Cycle 1 Day 1; pre-dose and 2, 3, 4, 6, 9, 11 and 24 hours post-dose on Cycle 1 Day 8
Sub-study 1: All 3 Parts: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC) of Venetoclax
Blood samples were collected at specified timepoints to determine AUC of venetoclax during dose escalation part. Participants missed few scheduled site visits for sample collection and only participants with data collected at specified timepoints are reported.
Measured: Part 1:Dose escalation (dose levels 1 and 2):Pre-dose and 2, 3, 4, 6, 11 and 24 hours post-dose on Cycle 1 Day 1
Sub-study 1: All 3 Parts: Maximum Plasma Concentration Observed of Azacitidine
Blood samples were collected at specified timepoints to determine Cmax of azacitidine during dose escalation part. Participants missed few scheduled site visits for sample collection and only participants with data collected at specified timepoints are reported. The PK samples were not collected at the end of infusion and were therefore outside the protocol-defined time window; consequently, Cmax could not be estimated and N = 0 in IV category. No participants received Azacitidine by SC route, thus N=0 in SC category.
Measured: Part 1:Dose escalation (dose levels 1 and 2):Pre-dose, 0.5, 1.5, 2.5, 4.5 and 9.5 hours post-dose on Cycle 1 Day 1
Sub-study 1: All 3 Parts: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity of Azacitidine
Blood samples were collected at specified timepoints to determine AUC of azacitidine during dose escalation part. Participants missed few scheduled site visits for sample collection and only participants with data collected at specified timepoints are reported. PK samples were not collected at the end of infusion; therefore, Cmax could not be estimated. In addition, PK samples collected outside the predefined time window resulted in insufficient data to calculate AUC, thus N=0 in IV category. No participants received Azacitidine by SC route, thus N=0 in SC category.
Measured: Part 1:Dose escalation (dose levels 1 and 2):Pre-dose, 0.5, 1.5, 2.5, 4.5 and 9.5 hours post-dose on Cycle 1 Day 1
Sub-study 1: All 3 Parts: Number of Participants With Anti-Drug Antibodies (ADAs) Against SAR443579
Plasma samples were collected to assess the antibodies to SAR443579 during dose escalation part. Treatment-emergent ADA was defined as a participant with at least 1 treatment-induced or treatment-boosted ADA-positive sample at any time during the treatment or follow-up observation period. Non-treatment emergent ADA was defined as participant without any treatment-induced, treatment-boosted ADA-positive or ADA-inconclusive sample during the treatment or follow-up observation period.
Measured: Part 1:Dose escalation (dose levels 1 and 2): first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 31.3 weeks
Sub-study 1: Part 3: Dose Expansion: Composite Complete Remission (CRc) Rate
The CRc rate was defined as the percentage of participants who had a response of CR, CRh or CRi as best overall response as assessed by the Investigator according to 2022 ELN recommendations for diagnosis and management of AML.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Sub-study 1: Part 3: Dose Expansion: Overall Response Rate
The ORR was defined as the percentage of participants who had a response of CR or CRi or CRh or partial remission (PR) or MLFS (morphological leukemia-free state) as best overall response as assessed by the Investigator according to the 2022 ELN criteria.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Sub-study 1: Part 3: Dose Expansion: Duration of Complete Remission
Duration of CR was defined as the time interval from the first documented evidence of CR until disease relapse as determined by the Investigator as per 2022 ELN recommendations or death due to any cause, whichever occurred first.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Sub-study 1: Part 3: Dose Expansion: Duration of Composite Complete Remission
Duration of CRc was defined as the time interval from first documented evidence of CRc (CR, CRh or CRi) until disease relapse as determined by the Investigator as per 2022 ELN recommendations or death due to any cause, whichever occurred first.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Sub-study 1: Part 3: Dose Expansion: Duration of Overall Response Rate
Duration of overall response rate was defined as the time from the first documented evidence of CR or CRi or CRh or PR or MLFS until disease relapse as determined by the Investigator as per 2022 ELN recommendations or death due to any cause, whichever occurred first.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Sub-study 1: Part 3: Dose Expansion: Alternative Complete Remission Rate
Alternative CR rate was defined as percentage of participants with alternative CR or CRh as best overall response as assessed by the Investigator.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Sub-study 1: Part 3: Dose Expansion: Duration of Alternative Complete Remission
Duration of alternative CR was defined as the time from the first documented evidence of alternative CR or CRh until disease relapse as determined by the Investigator as per 2022 ELN recommendations or death due to any cause, whichever occurred first.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Sub-study 1: Part 3: Dose Expansion: Event-Free Survival (EFS)
The EFS was defined as the time interval from the first day of treatment assignment until treatment failure, relapse from remission, or death from any cause, whichever occurred first.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Sub-study 1: Part 3: Dose Expansion: Overall Survival (OS)
The OS was defined as time interval from the day of treatment assignment to death from any cause.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Sub-study 1: Part 3: Dose Expansion: Percentage of Participants With Hematopoietic Stem Cell Transplantation (HSCT)
The HSCT rate was defined as the percentage of such participants who underwent HSCT through study treatment but before subsequent therapy, among the safety/exposed population.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Sub-study 1: Part 3: Dose Expansion: Time to Treatment Failure (TTF)
The TTF was defined as the time from first day of treatment assignment to the first discontinuation for any reason excluding remission, that is, relapsed disease, refractory disease, unacceptable AE, participant preference or death, whichever occurred first.
Measured: Tumor assessments were planned to be performed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapsed disease, refractory disease, unacceptable AE, participant preference or death due to any cause, whichever occurred first
Sub-study 1: All 3 Parts: Transfusion Independence (TI) Rate
The TI rate was defined differently for participants who were transfusion dependent (TD) at baseline and participants who were transfusion independent (TI) at baseline. For subgroup of participants with TD at baseline, the TI rate was defined as the percentage of participants who converted from baseline TD to TI during on treatment period; For subgroup of participants with TI at baseline, the TI rate was defined as the percentage of participants who remained TI during 56-day post baseline period during treatment.
Measured: Part 1:Dose escalation (dose levels 1 and 2): From Baseline (Day 1, before 1st dose of study treatment administration) to 56 days post-baseline during treatment period (Maximum exposure duration: 31.3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start13 Aug 2024
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Why it stopped: Early discontinuation based on strategic sponsor decision not driven by any safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508489
- Sponsor's protocol ID
- TCD17796
- Other IDs
- U1111-1280-6173, 2023-509438-20, 2023
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2024
- Last updated
- 19 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org