Engineered immune cells take aim at stubborn childhood leukemia

NCT ID NCT03876769

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

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

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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, 110032, 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, SE 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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