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Observational Study of CAR T-Cell Therapy Effects in Children and Young Adults

This study is looking at the short-term and long-term effects of CAR T-cell therapy in children and young adults up to 30 years old who have received this treatment for B-cell acute lymphoblastic leukemia (B-ALL), other blood cancers, or solid tumors. Researchers want to understand how often patients experience problems like infections, issues with blood cell recovery (bone marrow dysfunction), and nervous system side effects (persistent ICANS) within the first six months after CAR T-cell therapy. The study is also tracking these effects for up to two years. You could join if you received CAR T-cell therapy 1 to 3 months ago.

Study design
This is an observational study, meaning researchers will collect information from 100 participants. It is not testing a new treatment but rather observing the effects of an existing one.
What's involved
You would have assessments, specimen collection, and laboratory tests at 3 months, 6 months, 1 year, and 2 years after your CAR T-cell infusion.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 24 months after their CAR T-cell therapy to monitor for long-term effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06579469

Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy

Recruiting
Not specifiedUp to 30Observational
St. Jude Children's Research Hospital
~100 participants
Updated 2026-06-18 on ClinicalTrials.gov

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Presence of bone marrow dysfunction (BMD)
Measured over Within 6 months post CAR T-cell therapy
+2 more outcomes measured

Conditions

B-ALL
Hematologic Malignancy
Solid Tumor

Explore related trials

B-ALLHematologic NeoplasmSolid Neoplasm

NCT06579469

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Children's Hospital of Wisconsin.

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

  • Childrens Hospital of Colorado

    Aurora, Coloradostudy coordinator listed

    Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utahstudy coordinator listed

    Recruiting

  • Seattle Childrens Hospital

    Seattle, Washingtonstudy coordinator listed

    Recruiting

  • St. Jude Children's Research Hospital

    Memphis, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Rebecca Epperly, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Rebecca Epperly, MD
[email protected]
888-226-4343
Email the study team

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Eligibility criteria

Inclusion

Participants must have received an initial systemically-administered CAR T cell infusion within the last 1-3 months (+/- 14 days).
Initial infusion is defined as the first administration of a CAR T cell product the participant has not previously received OR receipt of a CAR T cell product previously received after an interval allogeneic HSCT.
Age ≤ 30 years at CAR T cell infusion.

Exclusion

Active malignancy other than the disease under study.
Planned consolidative HSCT within 3 months post CAR T cell infusion.
Received or planned additional disease directed therapy post CAR T cell infusion.
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

What this trial measures

  • Presence of bone marrow dysfunction (BMD)Within 6 months post CAR T-cell therapy

    Among patients in remission or without bone marrow involvement of disease in the B-ALL cohort, we will summarize the rates of prevalent BMD at 3- and 6-months post-infusion and estimate the cumulative incidence of new BMD and BMD recovery for patients with prevalent BMD at 3- and 6-months.

  • Occurrence of clinically significant infectionsWithin 6 months post CAR T-cell therapy

    The infection density of clinically significant infections in 3-6 months will be summarized in the B-ALL cohort.

  • Presence of persistent ICANSWithin 6 months post CAR T-cell therapy

    We will summarize the rates of persistent ICANS at 3- and 6-months post-infusion and estimate the cumulative incidence and timing of new ICANS and ICANS recovery for patients with persistent ICANS at 3- and 6-months in the B-ALL cohort.