RecruitingPhase 1NCT06017258

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

Phase I Trial of CLEc12a (CD371) Targeted ArmoRed Immune Effector Cells in Patients With Relapsed/Refractory Acute Myeloid Leukemia (CLEAR-AML)


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

15 participants

Start Date

Aug 22, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This study tests a new type of immune cell therapy called CAR T-cell therapy — specifically targeting a protein called CD371 — in people with acute myeloid leukemia (AML, a blood cancer) whose disease has not responded to standard treatments or has come back after treatment. **You may be eligible if...** - You have AML that carries the CD371 protein on cancer cells - Your leukemia has come back or has not responded to prior standard chemotherapy - You have adequate heart and organ function - You are willing to provide samples for research **You may NOT be eligible if...** - You are pregnant, breastfeeding, or not using contraception - You have active, uncontrolled brain involvement from leukemia - You have HIV, active Hepatitis B or C infection - You have severe heart problems (like heart failure or recent heart attack) - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD371-specific/YSNVz/I-18 CAR T cells

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.


Locations(7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

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

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06017258


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