Engineered donor cells take on childhood leukemia in first human test

NCT ID NCT04881240

Recruiting now Disease control Sponsor: St. Jude Children's Research Hospital Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new type of cell therapy for children and young adults up to age 21 with a form of leukemia (CD19-positive) that has returned or not responded to treatment. The therapy uses immune cells from a family donor that are engineered in a lab to recognize and attack leukemia cells. The main goal is to find a safe dose and understand side effects, including the risk of graft-versus-host disease. Up to 60 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: donor immune cells engineered to target leukemia cells (CD19-CAR T-cells)
What this could lead to: If it works, this could offer a new treatment option for children and young adults with leukemia that has come back or not responded to standard therapy.
What could go wrong: This is an early phase 1 trial, so the main goal is safety, not yet proof of effectiveness. There are risks of serious side effects like graft-versus-host disease or cytokine release syndrome.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia B-cell acute lymphoblastic leukemia childhood acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma refractory precursor T-lymphoblastic lymphoma/leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE LYMPHOBLASTIC LEUKEMIA, IN RELAPSE ACUTE LYMPHOBLASTIC LEUKEMIA, REFRACTORY PEDIATRIC ALL

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

St. Jude Children's Research Hospital
RECRUITING

Memphis, Tennessee, 38105, United States

Contact Email: •••••@•••••

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