RecruitingPhase 1NCT05748197

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

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

40 participants

Start Date

Apr 18, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

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. 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ADCLEC.syn1 — an antibody-drug conjugate that delivers a toxic payload directly to leukemia cells — in adults with acute myeloid leukemia (AML) that has returned or stopped responding to prior treatment. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory AML (your leukemia came back or did not respond to standard chemotherapy) - Your general health is adequate (ECOG 0 or 1) - You have a potential stem cell donor identified (in case of need for rescue) - Your kidney and liver function meet the study requirements **You may NOT be eligible if...** - You have acute promyelocytic leukemia (APL), a specific subtype of AML - You have active brain or spinal cord involvement from leukemia - You have significant heart, kidney, or liver problems - You currently have an active serious infection or uncontrolled illness 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

BIOLOGICALADCLEC.syn1 CAR T cells

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.

DRUGConditioning chemotherapy

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

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 Commack - Suffolk (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

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05748197

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