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

NCT ID: NCT07048535

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-24
• Study Completion Date: 2029-07-31

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.

Detailed Description

Advances in cancer immunotherapies, including CD19-redirected chimeric antigen receptor (CAR) T-cells, are changing the long-term outcome for B-ALL cancer patients.

The late effects of these treatments have not been investigated and the impact of this therapy on survivors' long-term outcomes and overall well-being is unknown.

The purpose of this study is to determine the feasibility of studying late effects following CAR T-cell therapy through a prospective, observational study for children, adolescent, and young adult (AYA) survivors who are ≥2-years post CD19-CAR T-cell infusion. The study will be the first study of late effects following CAR T-cell therapy recruiting B-ALL survivors from across the United States.

Eligible study participants will participate in a comprehensive health assessment. These assessments will include history and physical examination, laboratory studies, a brain MRI, physical performance testing, and neurocognitive testing. The CONQUER study will focus specific attention on data relevant to CD19-CAR T-cell therapy, including immune function.

Conditions

B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aimee Talleur, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aimee Talleur, MD

Role: CONTACT

referralinfo@stjude.org

866-278-5833

Facility Contacts

Aimee Talleur, MD

Role: primary

referralinfo@stjude.org

866-278-5833

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

CONQUER

Identifier Type: -

Identifier Source: org_study_id