RecruitingNCT07048535

CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions


Sponsor

St. Jude Children's Research Hospital

Enrollment

80 participants

Start Date

Oct 24, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

To learn more about the long-term health in patients treated for B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Cluster of Differentiation antigen 19 (CD19) -redirected chimeric antigen receptor (CAR) T-cells. Primary Objective: To evaluate the feasibility of conducting standardized clinical assessments of pediatric, adolescent and young adult (AYA) B-ALL survivors post CD19-CAR T-cell therapy, treated at multiple institutions, leveraging the St Jude Lifetime Cohort (SJLIFE) clinical and research infrastructure. Exploratory Objectives: * To describe the prevalence of persistent and new/late-onset health conditions developing ≥2-years post CD19-CAR T-cell therapy in survivors of pediatric and AYA B-ALL. * To characterize neurocognitive and neurologic function in survivors ≥2-years post CD19- CAR T-cell therapy. * To characterize immune health in survivors ≥2-years post CD19-CAR T-cell therapy. * To characterize functional status in survivors ≥2-years post CD19-CAR T-cell therapy.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study follows up with young people who received a type of immune cell therapy called CAR T-cell therapy to treat a blood cancer called B-cell acute lymphoblastic leukemia (B-ALL). Researchers want to understand long-term health effects, quality of life, and any lasting side effects years after treatment. **You may be eligible if:** - You were 26 years old or younger at the time of your first CAR T-cell treatment - You received a CD19-targeting CAR T-cell therapy (experimental or commercial) for B-ALL - You received only one type of CAR T-cell product (repeat infusions of the same product are okay) - You have been in remission without needing further treatment after CAR T-cell therapy (a stem cell transplant after CAR T is allowed) - You had no more than one bone marrow transplant in total - It has been at least 2 years since your last CAR T-cell infusion **You may NOT be eligible if:** - You or your legal guardian are unwilling or unable to provide written consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

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NCT07048535


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