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Engineered immune cells take aim at stubborn childhood leukemia

NCT ID NCT03876769

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 20, 2026 · Updated 4 times

Summary

This phase II trial tests a personalized cell therapy called tisagenlecleucel (Kymriah) in children and young adults with high-risk B-cell acute lymphoblastic leukemia who still have detectable cancer cells after initial chemotherapy. The treatment involves collecting the patient's own immune cells, genetically modifying them to recognize and attack leukemia cells, and infusing them back. The study aims to see if this approach can prevent relapse and improve survival without needing a stem cell transplant.

What this could mean

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

Active substance
tisagenlecleucel (a CAR-T cell therapy made from the patient's own immune cells)
What this could lead to
If successful, this could offer a way to eliminate remaining leukemia cells without needing a stem cell transplant, potentially improving long-term survival.
What could go wrong
This is a phase II trial with 121 participants, so results are still preliminary. CAR-T therapy can cause serious side effects like cytokine release syndrome and neurological problems.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

121 people

The number who actually took part.

Started

Jun 2019

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

1 year to 25 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: 1. CD19 expressing B-cell Acute Lymphoblastic Leukemia 2. De novo NCI HR B-ALL who received first-line treatment and are MRD ≥ 0.01% at EOC. EOC bone marrow MRD will be collected prior to screening and will be assessed by multi-parameter flow cytometry using central laboratory analysis. 3. Age 1 to 25 years at the time of screening 4. Lansky (age \< 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60% 5. Adequate organ function during the screening period: A. Renal function based on age/gender B. ALT ≤ 5 times ULN for age C. AST ≤ 5 times ULN for age D. Total bilirubin \< 2 mg/dL (for Gilbert's Syndrome subjects total bilirubin \< 4 mg/dL) E. Adequate pulmonary function defined as: * no or mild dyspnea (≤ Grade 1) * oxygen saturation of \> 90% on room air F. Adequate cardiac function defined as LVSF ≥ 28% confirmed by echocardiogram or LVEF ≥ 45% confirmed by echocardiogram or MUGA within 6 weeks of screening 6. Prior induction and consolidation chemotherapy allowed: 1st line subjects: ≤ 3 blocks of standard chemotherapy for first-line B-ALL, defined as 4-drug induction, Berlin-Frankfurt-Münster (BFM) consolidation or Phase 1b, and interim maintenance with high-dose methotrexate. Exclusion Criteria: 1. M3 marrow at the completion of 1st line induction therapy 2. M2 or M3 marrow or persistent extramedullary disease at the completion of first-line consolidation therapy or evidence of disease progression in the peripheral blood or new extramedullary disease prior to enrollment. Patients with previous CNS disease are eligible if there is no active CNS involvement of leukemia at the time of screening. 3. Philadelphia chromosome positive ALL 4. Hypodiploid: less than 44 chromosomes and/or DNA index \< 0.81, or other clear evidence of a hypodiploid clone 5. Prior tyrosine kinase inhibitor therapy 6. Subjects with concomitant genetic syndromes associated with bone marrow failure states: such as subjects with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Subjects with Down syndrome will not be excluded. 7. Subjects with Burkitt's lymphoma/leukemia (i.e. subjects with mature B-ALL, leukemia with B-cell \[sIg positive and kappa or lambda restricted positivity\] ALL, with FAB L3 morphology and /or a MYC translocation) 8. Has had treatment with any prior anti-CD19 therapy 9. Treatment with any prior gene or engineered T cell therapy Other protocol-defined inclusion/exclusion may apply.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia Burkitt lymphoma Neoplasm, Residual

As listed by the trial registrant

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

B-cell acute lymphoblastic leukemia

Contacts and locations

Locations

  • Children s Hospital of Alabama

    Birmingham, Alabama, 35233, United States

  • Children s Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Childrens Healthcare of Atlanta

    Atlanta, Georgia, 30342, United States

  • Childrens Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Childrens Hospital of Orange County

    Orange, California, 92868-3874, United States

  • Childrens Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Childrens National Hospital

    Washington D.C., District of Columbia, 20010, United States

  • Cinn Children Hosp Medical Center

    Cincinnati, Ohio, 45229-3039, United States

  • City of Hope National Medical

    Duarte, California, 91010, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Hackensack Uni Medical Center

    Hackensack, New Jersey, 07601, United States

  • Indiana University

    Indianapolis, Indiana, 46202-5225, United States

  • Johns Hopkins All Childrens

    St. Petersburg, Florida, 33701, United States

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21231, United States

  • Mattel Childrens Hospital UCLA

    Los Angeles, California, 90095, United States

  • Memorial Sloan Kettering Cancer Ctr

    New York, New York, 10065, United States

  • Methodist Childrens Hospital

    San Antonio, Texas, 78229, United States

  • Novartis Investigative Site

    Ghent, 9000, Belgium

  • Novartis Investigative Site

    Calgary, Alberta, T3B 6A8, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5G 1X8, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1C5, Canada

  • Novartis Investigative Site

    Copenhagen, DK-2100, Denmark

  • Novartis Investigative Site

    Paris, 75019, France

  • Novartis Investigative Site

    Roma, RM, 00165, Italy

  • Novartis Investigative Site

    Utrecht, 3584 CS, Netherlands

  • Novartis Investigative Site

    Oslo, 0424, Norway

  • Novartis Investigative Site

    Esplugues, Barcelona, 08950, Spain

  • Novartis Investigative Site

    Gothenburg, 416 85, Sweden

  • Novartis Investigative Site

    London, NW1 2BU, United Kingdom

  • Novartis Investigative Site

    London, WC1N 3JH, United Kingdom

  • Oregon Health and Science University

    Portland, Oregon, 97239-3098, United States

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016, United States

  • Rady Children s Hospital

    San Diego, California, 92123, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Stanford University Medical Center

    Stanford, California, 94304, United States

  • Texas Childrens Cancer and Hematology Center

    Houston, Texas, 77030, United States

  • The Childrens Hosp of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • Univ of Texas Southwest Med Center

    Dallas, Texas, 75390-9034, United States

  • University of Utah Clinical Trials Office

    Salt Lake City, Utah, 84108, United States

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