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Engineered immune cells take on tough leukemia in kids

NCT ID NCT06709469

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial is testing a type of immunotherapy called CAR T cells in children, adolescents, and young adults with acute lymphoblastic leukemia that has come back or not responded to standard treatments. The therapy involves taking the patient's own immune cells or donor cells, engineering them to better recognize and attack leukemia cells, and infusing them back. The main goal is to see if this approach is safe and feasible, with only 10 participants enrolled.

What this could mean

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

Active substance
CAR T cells (immune cells engineered to target cancer)
What this could lead to
If successful, this could offer a new treatment option for young patients with leukemia that has not responded to standard therapies.
What could go wrong
This is a very early phase 1 trial with only 10 participants, so safety and feasibility are the main goals. The treatment may cause serious side effects like cytokine release syndrome, and it is not yet known if it will effectively control the disease long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ARM A: CD19+/- CD22+ B-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available. Treatment with previous CART CD19 therapy is permitted, but is not mandatory, OR: * ARM B: T-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available. * Patients diagnosed with ALL must be suitable for allogeneic HSCT and willing to proceed to transplant if the CART treatment induces complete remission and the investigator believes it is the best option. * For ARM B there must be a suitable haploidentical donor (following local standard operating procedures). * Lansky (age \<16 years) or Karnofsky (age ≥16 years) score of 50 or greater. * Life expectancy greater than 12 weeks. * Absolute neutrophil count (ANC) ≥ 500/μL unless, in the opinion of the investigator, cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy. * Platelet count ≥ 50,000/μL unless, in the opinion of the investigator, cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy. * Absolute lymphocyte count ≥ 100/μL. * Adequate renal, hepatic, pulmonary, and cardiac function. * Adequate venous access and absence of contraindications for lymphoapheresis * Patients with a seizure disorder may be enrolled if well controlled with anticonvulsants. * Patients or patients' legal representative, parent(s), or guardian able to provide written informed consent. Exclusion Criteria: * Enrolled in another clinical trial in the previous 4 weeks. * Active infection requiring systemic medical therapy including clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV, adenovirus, BK-virus, HHV-6 or Aspergillus. * Any of the following cardiac criteria: cardiac echocardiography with LVSF\<30% or LVEF\<40%; or clinically significant pericardial effusion. * Presence of CNS-3 disease or uncontrolled seizure disorder. * Active immunosuppressive therapy with the exception of prednisone 10 mg/day (or equivalent), within 7 days prior to enrolment. * GFR \<30 ml/min or bilirubin \>3 times the upper limit of normality (unless due to Gilbert's syndrome). * Any other condition that, in the opinion of the PI, may interfere with the efficacy and/or safety evaluation of the trial. * Pregnant or lactating women. * Sexually active patients must be willing to utilize one of the more effective birth control methods for at least 12 months after the infusion and until CAR-T cells are no longer present on two consecutive tests. Male partner should use a condom. Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant. * Sexually active males should use a condom during intercourse for at least 12 months after the infusion and until CAR-T cells are no longer present on two consecutive tests.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Madrid, 28046, Spain

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