NCT06017258

Brief Summary

The purpose of this study is to find out whether CD371-YSNVZ-IL18 CAR T cells are safe, and to look for the highest dose of CD371-YSNVZ-IL18 CAR T cells that cause few or mild side effects in participants.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
4mo left

Started Aug 2023

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Aug 2023Aug 2026

Study Start

First participant enrolled

August 22, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

August 24, 2023

Last Update Submit

February 18, 2026

Conditions

Refractory Acute Myeloid LeukemiaRelapsed Acute Myeloid LeukemiaAcute Myeloid LeukemiaAcute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia Refractory

Keywords

Refractory Acute Myeloid LeukemiaRelapsed Acute Myeloid LeukemiaAcute Myeloid LeukemiaAcute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia RefractoryArmoRedCLEAR-AMLCLEc12aCD371Memorial Sloan Kettering Cancer Center23-016

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of CAR T cells

    Determine the Maximum Tolerated Dose/MTD of CAR T cells in participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

    up to 6 months

Study Arms (3)

Dose Level 1

EXPERIMENTAL

Participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Biological: CD371-specific/YSNVz/I-18 CAR T cells

Dose Level 2

EXPERIMENTAL

Participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Biological: CD371-specific/YSNVz/I-18 CAR T cells

Step-Down Dose

EXPERIMENTAL

Participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Biological: CD371-specific/YSNVz/I-18 CAR T cells

Interventions

CD371-specific/YSNVz/I-18 CAR T cellsBIOLOGICAL

Cohorts will be infused with escalating doses of CD371-specific/YSNVz/IL-18 CAR T cells with lymphodepleting chemotherapy (LDC) to establish the maximum tolerated dose (MTD). There is a third, lower dose level (step-down dose) available for dose de-escalation in the event of severe toxicity at the first planned dose level.

Dose Level 1Dose Level 2Step-Down Dose

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • History of CD371+ AML
  • Any disease status is eligible for collection
  • Expression of CD371 at any level on AML blasts (any method of detection including IHC and/or flow cytometry)
  • Age/Weight
  • Pediatrics: ≥ 1 year and ≥ 10kg for collection
  • Adults: no limit on age/weight for collection
  • Patients with history of allo-HCT are eligible for collection if:
  • ≥ 100 days post-transplant
  • no evidence of active GVHD
  • off any immunosuppressive agents for 30 days prior to collection (physiologic dose of corticosteroids is acceptable)
  • Relapsed/Refractory CD371+ AML (meeting criteria defined below) for primary refractory AML, late first relapse, and/or advanced disease:
  • o Primary refractory AML: Patients are eligible from disease perspective in the event of failure to achieve a CR, CRh or CRi after one or more of the following regimens:
  • Two or more courses of standard intensive induction chemotherapy (e.g., cytarabine and daunorubicin given as "7+3," MEC, HiDAC, FLAG+idarubicin, etc.);
  • Two or more cycles of venetoclax in combination with one of the following (azacitidine OR decitabine OR low-dose cytarabine), with or without other agents;
  • Six or more cycles of azacitidine monotherapy OR four or more courses of decitabine monotherapy
  • +27 more criteria

You may not qualify if:

  • Pregnant or lactating women; women of childbearing age, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while receiving study treatment and for at least 12 months after all treatment is finished
  • Sexually active males, unless they are willing to use a condom during intercourse while receiving study treatment and for at least 12 months after all treatment is finished
  • Radiographically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥ 5/ul WBC in CSF). Subjects with adequately treated CNS leukemia are eligible.
  • Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject
  • Impaired cardiac function (LVEF \< 50%) as assessed by ECHO or MUGA scan
  • Patients with following cardiac conditions will be excluded:
  • New York Heart Association (NYHA) stage III or IV congestive heart failure
  • Myocardial infarction ≤ 6 months prior to enrollment
  • History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
  • 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
  • Patient/parent/LAR unable to give informed consent/
  • Bridging chemotherapy occurring \< 1 week prior to administration of LDC
  • o Exception: hydroxyurea can be continued up to 72 hours prior to leukapheresis or 24 hours prior to LDC
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Publications (1)

  • Geyer MB, DeWolf S, Mi X, Weis K, Shaffer BC, Cadzin B, McAvoy D, Katsamakis Z, Lorenc R, Lewis AM, Gipson B, Cuibus MA, Girotra NN, Wu K, Smith N, Burns ER, Um JS, Yoo S, Masouleh BK, Galera P, Hosszu K, Chaudhari J, Wang X, Lin Q, Curran KJ, Park JH, Scheinberg DA, van den Brink MRM, Abdel-Wahab O, Brentjens RJ, Daniyan AF. CD371-targeted CAR T cells secreting interleukin-18 exhibit robust expansion and clear refractory acute myeloid leukemia. Blood. 2025 Dec 25;146(26):3163-3174. doi: 10.1182/blood.2025029532.

    PMID: 40864984DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Mark Geyer, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Geyer, MD

CONTACT

646-608-3745geyerm@mskcc.org

Jae Park, MD

CONTACT

646-608-3743parkj6@mskcc.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2023

First Posted

August 30, 2023

Study Start

August 22, 2023

Primary Completion (Estimated)

August 22, 2026

Study Completion (Estimated)

August 22, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)