Recruiting

CAR-T Cell Therapy

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06579469

Conditions

B-ALL

Hematologic Malignancy

Solid Tumor

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

B-ALL

Hematologic Malignancy

Solid Tumor

Study ID

NCT06579469

Start date

Jan 20, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Presence of bone marrow dysfunction (BMD) [ Time Frame: Within 6 months post CAR T-cell therapy ]
  • Occurrence of clinically significant infections [ Time Frame: Within 6 months post CAR T-cell therapy ]
  • Presence of persistent ICANS [ Time Frame: Within 6 months post CAR T-cell therapy ]

Central Contacts and Locations

Central contacts

Rebecca Epperly, MD

888-226-4343referralinfo@stjude.org

Locations

Childrens Hospital of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Hesham Eissa, MD, MSc

720-777-4151hesham.eissa@childrenscolorado.org

Principal Investigator:

Hesham Eissa, MD, MSc

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Regina Myers, MD

215-590-1000Myersm@chop.edu

Principal Investigator:

Regina Myers, MD

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Rebecca Epperly, MD

888-226-4343referralinfo@stjude.org

Principal Investigator:

Rebecca Epperly, MD

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Joseph G. Dolan, MD

801-662-4700gregory.dolan@hsc.utah.edu

Principal Investigator:

Joseph G Dolan, MD

Seattle Childrens Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Mallory Taylor, MD

206-884-1582molly.taylor@seattlechildrens.org

Principal Investigator:

Mallory Taylor, MD

Children's Hospital of Wisconsin.

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Amy Moskop, MD

414-955-4142amoskop@mcw.edu

Principal Investigator:

Amy Moskop, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • CAR T cell infusion
  • Late Effects

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 2026-06-18.