Actively Recruiting

Phase 1
Age: 1Year +
All Genders
NCT06017258

A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-19

15

Participants Needed

7

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia

Who Can Participate

Age: 1Year +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of CD371-positive acute myeloid leukemia (AML)
  • Age 1 year or older and weight at least 10 kg for cell collection; no age/weight limit for adults
  • Patients with prior allogeneic hematopoietic stem cell transplant (allo-HCT) eligible if at least 100 days post-transplant, no active graft-versus-host disease (GVHD), and off immunosuppressive agents for 30 days prior to collection or treatment
  • Relapsed or refractory CD371-positive AML meeting disease-specific criteria for primary refractory, early or late first relapse, or advanced disease
  • Adequate performance status: ECOG 0-1 or Karnosfsky 60 or higher for patients 16 years and older; Lansky 60 or higher if under 16 years
  • Identification of suitable donor/source for allo-HCT as determined by treating physician
  • Adequate organ function including liver, kidney, heart, and lung as defined in study criteria
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women; women of childbearing potential not using effective contraception during and for 12 months after treatment
  • Sexually active males not willing to use condoms during and for 12 months after treatment
  • Radiographically detected or symptomatic central nervous system (CNS) disease, except adequately treated CNS leukemia
  • Uncontrolled symptomatic illness including infection or psychiatric illness that would limit study compliance or pose unacceptable risk
  • Impaired cardiac function with left ventricular ejection fraction below 50% or severe heart conditions such as NYHA class III/IV heart failure, recent myocardial infarction, or significant arrhythmia
  • Positive HIV test
  • Acute or chronic hepatitis B or C infection
  • Use of bridging chemotherapy less than 1 week before lymphodepleting chemotherapy, except certain exceptions
  • Isolated extramedullary disease
  • Lack of suitable donor/source for allogeneic HSCT
  • Active second malignancy requiring systemic treatment, except curatively treated malignancy without disease for over 2 years
  • Unable to give informed consent
  • Any other condition deemed by the investigator to make participation unsafe or unfeasible

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

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

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States, 11553

Actively Recruiting

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Research Team

M

Mark Geyer, MD

CONTACT

J

Jae Park, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia | DecenTrialz