Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on the Safety and Effectiveness of Brexucabtagene Autoleucel for Children and Teens with Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two types of blood cancers: Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma. These are conditions where the cancer has returned or has not responded to previous treatments. The treatment being tested in this study is called KTE-X19, which is a type of cell therapy. This therapy involves using a patient's own immune cells, which are modified in a laboratory to better recognize and attack cancer cells. The modified cells are then infused back into the patient to help fight the cancer.

The purpose of the study is to evaluate the safety and effectiveness of KTE-X19 in children and adolescents with these types of blood cancers. The study is divided into two phases. In the first phase, the focus is on assessing the safety of the treatment. In the second phase, the study aims to determine how well the treatment works in achieving remission, which means the cancer is no longer detectable. Participants will receive the treatment through an intravenous infusion, which is a method of delivering medication directly into the bloodstream.

Throughout the study, participants will be closely monitored for any side effects and to see how their cancer responds to the treatment. The study will also look at how long any remission lasts and overall survival rates. This research is important for understanding how effective KTE-X19 is in treating these challenging forms of cancer in young patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria related to age, weight, and medical history.

    The study focuses on individuals with relapsed or refractory B-precursor acute lymphoblastic leukemia or B-cell non-Hodgkin lymphoma.

  2. Step 2

    Initial assessment

    A comprehensive health assessment is conducted to ensure adequate renal, hepatic, pulmonary, and cardiac function.

    Performance status is evaluated using the Lansky or Karnofsky scale, depending on age.

  3. Step 3

    Treatment preparation

    Preparation for treatment involves confirming the absence of significant health issues such as pleural effusion or arrhythmias.

    Baseline oxygen saturation must be above 92% on room air.

  4. Step 4

    Treatment administration

    The treatment involves the administration of brexucabtagene autoleucel through an intravenous infusion.

    The product used is Tecartus 0.4 - 2 x 108 cells dispersion for infusion.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the incidence of adverse events and the body's response to the treatment.

    The primary focus is on evaluating the safety and efficacy of the treatment, with specific attention to remission rates and overall survival.

  6. Step 6

    Completion and evaluation

    The study aims to conclude by April 2026, with ongoing evaluations of treatment outcomes.

    Secondary outcomes include the duration of remission, progression-free survival, and changes in patient-reported outcomes.

Who can join the trial?

13 criteria

  • Must have a type of cancer called **relapsed or refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL)** or **relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL)**.
  • For NHL, the cancer must be aggressive and confirmed by a test called a **histology**.
  • For ALL, the cancer must be relapsed or refractory, meaning it has returned or not responded to treatment.
  • Must have received certain previous treatments, including a medicine called **anti-CD20 monoclonal antibody** and a type of chemotherapy that includes **anthracycline**.
  • Must be under 18 years old and weigh at least 6 kg (about 13 pounds).
  • Must have a good level of daily activity, measured by a score called **Lansky** (for those under 16) or **Karnofsky** (for those 16 and older), with a score of 80 or higher.
  • Must have good kidney, liver, lung, and heart function. This includes:
    • Kidney function: **Creatinine clearance** of at least 60 mL/min.
    • Liver function: **ALT/AST** levels no more than 5 times the normal limit, and **total bilirubin** no more than 1.5 times the normal limit, unless you have a condition called **Gilbert's syndrome**.
    • Heart function: **Left ventricular shortening fraction (LVSF)** of at least 30% or **left ventricular ejection fraction (LVEF)** of at least 50%, with no significant fluid around the heart or irregular heartbeats.
    • Lung function: Oxygen levels in the blood must be more than 92% when breathing room air.
    • For ALL, must have a certain amount of cancer cells in the bone marrow or be positive for **Minimal/Measurable Residual Disease (MRD)**, which is a small number of cancer cells that remain after treatment.
    • If you have a type of ALL called **Ph+ disease**, you can participate if you cannot tolerate a treatment called **tyrosine kinase inhibitor (TKI)** therapy, or if the disease has returned or not responded after trying at least two different TKIs.
    • Must be 21 years old or younger and weigh at least 6 kg (about 13 pounds) at the time of agreeing to participate.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer than the ones being studied cannot participate.
  • Patients who have not experienced a return or resistance to treatment of their cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to follow the study procedures or attend required visits cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have received certain treatments recently that might affect the study cannot participate.
  • Patients who have allergies to the study medication or its ingredients cannot participate.
  • Patients who are participating in another clinical trial at the same time cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

KTE-X19 is a treatment being studied for its safety and effectiveness in children and teenagers who have certain types of blood cancers that have come back or have not responded to previous treatments. These cancers include B-precursor Acute Lymphoblastic Leukemia and B-Cell Non-Hodgkin Lymphoma. The study aims to see how well this treatment works in achieving remission, which means the cancer is no longer detectable, and to understand any side effects it may cause.

What is already known about the treatment

KTE-X19 – This medication is administered through an intravenous infusion and is currently being studied in clinical trials for its safety and effectiveness. It is primarily used for treating relapsed or refractory B-precursor acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma in pediatric and adolescent patients. KTE-X19 works by modifying the patient's own T-cells to better recognize and attack cancer cells, a process known as CAR T-cell therapy. It falls under the pharmacological classification of immunotherapy, specifically as a chimeric antigen receptor (CAR) T-cell therapy.

Investigated diseases

  • Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL)

    This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells called lymphoblasts. In relapsed or refractory cases, the disease returns after treatment or does not respond to initial therapy. The progression involves the accumulation of these abnormal cells, which can crowd out normal blood cells, leading to symptoms like fatigue, infections, and bleeding. The disease can spread to other parts of the body, including the lymph nodes, liver, and spleen. It primarily affects children and young adults, but can occur at any age.

  • Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (r/r NHL)

    This is a group of blood cancers that originate in the lymphatic system, specifically affecting B-lymphocytes. In relapsed or refractory cases, the lymphoma returns after treatment or does not respond to initial therapy. The disease progresses as cancerous B-cells multiply uncontrollably, forming tumors in lymph nodes and potentially spreading to other organs. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. It can affect individuals of any age, but certain types are more common in adults.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509440-97-00Protocol codeKTE-C19-104Estimated enrolment95 patientsSponsorKite Pharma Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).