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Monitoring B-Cell Recovery After CAR T-cell Therapy for B-ALL

This study is for children and young adults (ages 1 to 25) with B-cell Acute Lymphoblastic Leukemia (B-ALL) who have received CD19 CAR T-cell therapy and are in remission. The goal is to see if regular blood and bone marrow tests, specifically Next-Generation Sequencing (NGS) testing, can help doctors monitor for signs of B-ALL relapse. CAR T-cell therapy is an immunotherapy that can treat B-ALL, but some patients may relapse. This study aims to find better ways to identify patients at high risk of relapse so they can receive additional treatment, like a stem cell transplant, if needed, while avoiding unnecessary treatments for those who are likely to stay in remission. You must have a confirmed diagnosis of CD19+ B-ALL and an informative NGS clonality sample to join. The study plans to enroll 60 participants, and its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific intervention (NGS testing). It is designed to evaluate a new strategy for monitoring remission.
What's involved
Participants will undergo NGS testing using blood and bone marrow samples at regular intervals. The primary endpoint is measured from baseline to one year after CD19 CAR T-cell infusion.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for at least one year after their CD19 CAR T-cell infusion to assess the effectiveness of the monitoring strategy.

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NCT05621291

A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...

Recruiting
NAAges 1–25InterventionalDiagnostic
National Cancer Institute (NCI)
~60 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:NGS testing

At a glance

Recruiting sites
6 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of novel biomarker-guided risk based strategy to monitor remission
Measured over baseline to 1 year post CD19 CART infusion

Conditions

B-All
Acute Lymphoblastic Leukemia

Explore related trials

B Acute Lymphoblastic LeukemiaNGS clonality

Where it's being run

8 sites across 7 states
Washington2
California1
District of Columbia1
Georgia1
Maryland1
Massachusetts1
Utah1

Study leadership

  • Alexandra Dreyzin, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

NCI Ped LeukemiaLymph Cell Tx Tm
[email protected]
(240) 760-6970
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \>=1 year and \<= 25 years old at the time of CD19 CART infusion
Confirmed diagnosis of CD19+ B-ALL with an informative NGS clonality sample
Have an informative NGS clonality sample for MRD assessment based on immunoglobulin rearrangement in bone marrow or blood at any time of active disease between diagnosis and CD19 CART infusion and any time prior to the first on-study intervention confirmed by NGS MRD testing.
Post-CD19 CART infusion disease status:
Are in bone marrow morphologic complete remission and are flow cytometry measurable residual disease (MRD) negative within 42 days post CD19 CART infusion.
Are NGS MRD negative by tracking sample in the bone marrow within 42 days post CD19 CART infusion confirmed by NGS MRD testing.
Received first CD19 (4-1BB) CART within 42 days prior to enrollment. Note: Eligible CART including FDA approved Kymriah (tisagenlecleucel) infused on a treatment plan, research study, or other comparable 4-1BB based constructs.
All participants must have an allogeneic HCT donor identified for potential HCT. Note: Donor identification and selection will be according to institutional practice.
Have B-cell aplasia (BCA) post CD19 CART persisting within 42 days post CD19 CART infusion. Note: BCA persisting is defined as \<1% B cells lymphocytes or \<50 B cells/microliter in the peripheral blood
Performance of all screening tests prior to day 42 post CD19 CART.
The ability of participant or parent/guardian to understand and the willingness to sign a written consent document or participants unable to consent if they are represented by a Legally Authorized Representative (LAR).

Exclusion

Prior hematopoietic stem cell transplantation (HCT)
Recent history of the extramedullary disease (EMD) that requires ongoing radiographic surveillance (e.g., participants with active EMD at CD19 CART infusion that requires monitoring by imaging without the ability to more precisely assess disease status will be ineligible). A remote history of EMD does not exclude the participant.
Active and/or residual central nervous system (CNS) disease that requires ongoing therapy or monitoring.
Co-morbidities precluding myeloablative HCT. Note: Determination of co-morbidities precluding myeloablative HCT will be made by the treating transplant (HCT) physician and documented in the research record. This does not require that the participant is immediately fully eligible for HCT, only that there are no long-term comorbidities that would preclude a myeloablative approach (e.g., renal failure, severe cardiac failure, long-term oxygen requirement).
Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements. Note: Determination of uncontrolled, symptomatic illness or social situation that would limit compliance with the study requirements will be made by the site-PI and documented in the research record.

What this trial measures

  • Efficacy of novel biomarker-guided risk based strategy to monitor remissionbaseline to 1 year post CD19 CART infusion

    NGS MRD testing of blood and bone marrow samples and evaluation of BCA