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NCT07048535Recruiting

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

Source: ClinicalTrials.gov · Last updated 29 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
80 (estimated)
First submitted
24 Jun 2025
Start date
24 Oct 2025
Primary completion date
31 Jul 2028
Lead sponsor
St. Jude Children's Research Hospital
NCT number
NCT07048535

What you commit to

  • Study type: Observational
  • Planned participants: 80
  • From 24 Oct 2025 to the primary completion date, 31 Jul 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent

Who the study is looking for

  • ≤ 26-years old at the time of the first CAR treatment
  • Receipt of a CD19-containing CAR T-cell product (investigational or commercial) for B- ALL
  • Receipt of one unique CAR product (reinfusion of same product allowed)
  • Sustained remission without subsequent therapy post-CAR (exception= post-CAR consolidative HCT)
  • Receipt of only one prior HCT (inclusive of pre- or post-CAR)
  • ≥ 2-years post last CAR T-cell infusion

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Jude Children's Research Hospital
Coordinator of this site? Confirm its status
MemphisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.