Fresh donor cells take on childhood leukemia in early trial

NCT ID NCT06080191

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

Summary

This early-stage trial is testing a one-time infusion of specially engineered immune cells from a healthy donor in 24 children and young adults with B-cell acute lymphoblastic leukemia that has come back or not responded to treatment. The main goal is to check safety and find the best dose, while also watching for signs that the cells are working. Because the cells come from another person, there is a risk of graft-versus-host disease, so the study is carefully monitoring for that.

What this could mean

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

Active substance
donor-derived CD19-targeted CAR T-cells
What this could lead to
If successful, this could provide a new treatment option for children with hard-to-treat leukemia who have run out of standard therapies.
What could go wrong
This is a very early phase 1 trial with only 24 participants, so safety and dosing are still being figured out. There are serious risks like severe immune reactions or graft-versus-host disease.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Ospedale Pediatrico Bambino Gesù

    RECRUITING

    Rome, Italy, 00165, Italy

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