Recruiting

CD19-CAR T-Cells

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07048535

Conditions

B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Study ID

NCT07048535

Start date

Oct 24, 2025

Status verified date

Apr, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≤ 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

Exclusion Criteria:

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy [ Time Frame: Through study completion, approximately 5 years ]

Central Contacts and Locations

Central contacts

Aimee Talleur, MD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Aimee Talleur, MD

888-226-4343referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • B-Cell Acute Lymphoblastic Leukemia
  • B-ALL
  • Survivorship

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-04-29.