NCT06579469

Brief Summary

This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
34mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Mar 2029

First Submitted

Initial submission to the registry

August 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

August 28, 2024

Last Update Submit

March 26, 2026

Conditions

B-ALLHematologic MalignancySolid Tumor

Keywords

CAR T cell infusionLate Effects

Outcome Measures

Primary Outcomes (3)

  • Presence of bone marrow dysfunction (BMD)

    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.

    Within 6 months post CAR T-cell therapy

  • Occurrence of clinically significant infections

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

    Within 6 months post CAR T-cell therapy

  • Presence of persistent ICANS

    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.

    Within 6 months post CAR T-cell therapy

Secondary Outcomes (7)

  • Presence of bone marrow dysfunction (BMD)

    Within 24 months post CAR T-cell therapy

  • Severity of BMD

    Within 24 months post CAR T-cell therapy

  • Occurrence of clinically significant infections

    Within 24 months post CAR T-cell therapy

  • Time to the earliest clinically significant infection

    Within 24 months post CAR T-cell therapy

  • Severity of clinically significant infections

    Within 24 months post CAR T-cell therapy

  • +2 more secondary outcomes

Study Arms (3)

B cell acute lymphoblastic leukemia (B cell acute lymphoblastic leukemia (B-ALL) ) cohort

B-ALL participants who have received initial CAR T cell therapy within the last 1-3 months.

Other hematologic malignancy

Other hematologic malignancy participants who have received initial CAR T cell therapy within the last 1-3 months.

Solid tumor (ST)

ST participants who have received initial CAR T cell therapy within the last 1-3 months.

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants who have received CAR T cell therapy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Children's Hospital of Wisconsin.

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood and bone marrow

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Rebecca Epperly, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Epperly, MD

CONTACT

866-278-5833referralinfo@stjude.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2024

First Posted

August 30, 2024

Study Start

January 20, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2029

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(3)