RecruitingPhase 1NCT06287528

A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL)

A Phase I Trial of CD19-targeted Chimeric Antigen Receptor (CAR) T Cells That Constitutively Secrete Interleukin 18 (19-28z/IL-18) in Patients With Relapsed or Refractory (R/R) Acute Lymphoblastic Leukemia (ALL)


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

18 participants

Start Date

Feb 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory to be changed (modified) to become 19-28z/IL-18, the CAR T-cell therapy that participants will receive during the study. Making the participants' study therapy will take about 2-4 weeks.


Eligibility

Min Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a modified CAR-T cell therapy called 19-28z/IL-18 in patients with B-cell acute lymphoblastic leukemia (ALL) — a blood cancer — that has returned or did not respond to previous treatments. **You may be eligible if...** - You have B-cell ALL that has relapsed or not responded to at least one prior chemotherapy regimen - If you have Philadelphia chromosome-positive ALL, your disease has persisted despite at least one newer targeted therapy (TKI) - The first patients enrolled must be 17 or older; later patients may be 12 or older **You may NOT be eligible if...** - Your leukemia does not have the CD19 marker that the therapy targets - Your organ function does not meet minimum health requirements - You have active serious infections or serious autoimmune conditions 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

BIOLOGICAL19-28z/IL-18 CAR T cells

19-28z/IL-18 CAR T cells are an investigational new drug (IND) for the treatment of R/R B-ALL


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 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 Activities)

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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NCT06287528


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