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Acute Myeloid LeukemiaPhase 1NCT05748197

A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia

A Phase 1 study testing ADCLEC.syn1 CAR T cells and Conditioning chemotherapy in people with Acute Myeloid Leukemia, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to test the safety of ADCLEC.syn1 CAR T cells in people with relapsed or refractory AML. The researchers will try to find the highest dose of ADCLEC.syn1 CAR T cells that causes few or mild side effects in participants. 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?
ADCLEC.syn1 CAR T cells and Conditioning chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
7 sitesUnited States
Study dates
18 Apr 2024to 18 Apr 2028
Phase
Phase 1
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

  • Age ≥18 years of age at the time of signing informed consent.
  • Patients must have R/R AML. The following disease status will be eligible for the study:
  • Refractory AML is defined as failure to achieve a CR, CRh or CRi after one of the following regimens: i. At least one course of standard intensive induction chemotherapy (e.g., 7+3, MEC, HiDAC, etc.) or hypomethylating agent (HMA) or low dose cytarabine-based combination regimen including but not limited to venetoclax (e.g. venetoclax in combination with azacytidine, decitabine or cytarabine) ii. Four cycles of HMA monotherapy b. Relapsed AML is defined the appearance of ≥5% blasts in the bone marrow or peripheral blood at any time after achieving a CR, CRh, or CRi.
  • ECOG performance status 0 or 1.
  • Subjects must have a suitable stem cell donor identified who may donate cells in the event that the subject needs to undergo an allogeneic HSCT for rescue from prolonged marrow aplasia.
  • Donor may be from related or unrelated matched source, haplo or cord, and must be found to be suitable according to the institution's standard criteria.
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  • Adequate organ function defined as:
  • Serum creatinine <2.0 mg/100 mL.
  • Total bilirubin <2.0 mg/100 mL, unless benign congenital hyperbilirubinemia or due to leukemia organ involvement
  • AST and/or ALT ≤5 × ULN, unless considered due to leukemic organ involvement.

Who cannot join

  • Diagnosis of acute promyelocytic leukemia.
  • Radiologically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥5/µL WBCs in CSF). Subjects with adequately treated CNS leukemia are eligible.
  • Oxygen saturation <90% on room air.
  • Patients with prior allogeneic HSCT are allowed as long as HSCT occurred > 3 months of signing ICF and without ongoing requirement for systemic graft-versus-host therapy.
  • Treatment with clofarabine or cladribine within 3 months prior to leukapheresis
  • The following medications are excluded:
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  • Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.
  • Chemotherapy: Bridging chemotherapy including venetoclax must be discontinued at least 1 week prior to administration of conditioning chemotherapy, but FDA-approved oral targeted therapies such as IDH1/2, FLT3, and menin inhibitiors as well as hydroxyurea can be continued until at least 24 hours prior to the start of conditioning chemotherapy
  • Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months prior to first study medication; or the presence of unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher; or cardiac ejection fraction <40%.
  • Uncontrolled clinically significant infections such as ongoing fever for 48 hours, persistent bacteremia or requiring new supplemental oxygen.
  • Positive serologic test results for HIV.
  • Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.
  • Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR.
  • Active second malignancy that requires systemic treatments, with the exception of malignancy treated with curative intent and without evidence of disease for >2 years before screening.
  • Live vaccine within 4 weeks prior to leukapheresis
  • Pregnant or lactating/breastfeeding women
  • Any prior or ongoing condition/issue that in the opinion of the investigator would make the patient ineligible for study

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jae Park, MD contact

646-608-2091

parkj6@mskcc.org

Mark Geyer, MD contact

646-608-3745

7 sites in 1 country

United States7 sites, 7 recruiting

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Jae Park, MD, 646-608-2091

    Recruiting

  • Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)

    Commack, New York, 11725

    Jae Park, MD, 646-608-2091

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

    Jae Park, MD, 646-608-2091

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

    Jae Park, MD, 646-608-2091

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Jae Park, MD, 646-608-2091

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Jae Park, MD, 646-608-2091

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

    Jae Park, MD, 646-608-2091

    Recruiting

Other trials in United States

About this study

Official title: A Phase I Study of ADCLEC.syn1 CAR T Cells in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia

The purpose of this study is to test the safety of ADCLEC.syn1 CAR T cells in people with relapsed or refractory AML. The researchers will try to find the highest dose of ADCLEC.syn1 CAR T cells that causes few or mild side effects in participants. Once the researchers find this dose, it will test it in a new group of participants to see if it is effective in treating their relapsed/refractory AML.

Being tested
ADCLEC.syn1 CAR T cells, Conditioning chemotherapy
Keywords
Relapsed, Refractory, ADCLEC.syn1 CAR T cells, Cyclophosphamide, Fludarabine, 23-002
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.

  • ADCLEC.syn1 CAR T cellsBiological

    There are 4 planned flat-dose levels: 25 × 10^6, 75 × 10^6 , 225 × 10^6 , and 450 × 10^6 CAR T cells and 1 de-escalation dose: 10 × 10^6 CAR T cells.

  • Conditioning chemotherapyDrug

    Fludarabine 30 mg/m2 daily for 3 days and cyclophosphamide 500 mg/m2 daily for 3 days.

Study groups in NCT05748197
Study groupRoleWhat they receive
ADCLEC.syn1 CAR T cellsExperimentalThe dose escalation cohort size of 3 patients in each cohort will be infused with escalating doses of ADCLEC.syn1 CAR T cells to inform the RP2D. There are 4 planned flat-dose levels: 25 × 10^6, 75 × 10^6 , 225 × 10^6 , and 450 × 10^6 CAR T cells and 1 de-escalation dose: 10 × 10^6 CAR T cells. After dose escalation, one or two dose levels will be selected for dose expansion cohort(s).Two to 7 days following completion of the conditioning chemotherapy, the frozen CAR T cells will be thawed and administered. Conditioning chemotherapy may occur either outpatient or inpatient, and T cell infusions will occur as inpatient. Up to approximately 12 additional patients each if two doses are selected or approximately 16 additional patients, if one dose is selected, will be treated in the dose expansion phase to determine RP2D.
Receives: Biological: ADCLEC.syn1 CAR T cells; Drug: Conditioning chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maximum tolerated dose (MTD)

    Dose escalation of ADCLEC.syn1 CAR T cells will follow Bayesian optimal interval (BOIN) design to inform dose-escalation decisions and potential maximum tolerated dose (MTD) estimation. Patients will be enrolled in cohorts of 3.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2023
  2. Study start18 Apr 2024
  3. Primary completion18 Apr 2028 (estimated)
  4. Study completion18 Apr 2028 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
This is a phase I, open-label, dose-escalation/dose expansion trial.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05748197
Sponsor's protocol ID
23-002
Status last verified
Mar 2026
First submitted
17 Feb 2023
Last updated
10 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Publications

  • Haubner S, Mansilla-Soto J, Nataraj S, Kogel F, Chang Q, de Stanchina E, Lopez M, Ng MR, Fraser K, Subklewe M, Park JH, Wang X, Riviere I, Sadelain M. Cooperative CAR targeting to selectively eliminate AML and minimize escape. Cancer Cell. 2023 Nov 13;41(11):1871-1891.e6. doi: 10.1016/j.ccell.2023.09.010. Epub 2023 Oct 5.

    PubMed 37802054

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ADCLEC.syn1 CAR T cells and Conditioning chemotherapy in people with Acute Myeloid Leukemia, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

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 10 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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 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.

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?

Contact Jae Park, MD (646-608-2091, parkj6@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximum tolerated dose (MTD) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05748197, which also lists 1 linked publication.

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 10 Mar 2026.

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