Recruiting

NGS with CART

Sponsor:

National Cancer Institute (NCI)

Code:

NCT05621291

Conditions

B-All

Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 1 - 25

Healthy Volunteers: Not accepted

Interventions

NGS testing

Study Details

Brief summary:

Background:

Chimeric antigen receptor T-cell (CART) therapy is a form of immunotherapy which can be used to treat people with relapsed B-ALL. For those who achieve remission after CART alone, it may cure up to 50% of people who receive this therapy. However, for people who relapse after CART, it can be hard to achieve remission again. In patients where CART fails, stem cell transplant (HCT) can be used to prevent relapse and achieve cure. But HCT can cause serious side effects. Better testing is needed to distinguish people who can be cured with CART alone from people who may also need to have HCT.

Objective:

To see if the use of a series of blood and bone marrow tests at regular intervals can help monitor for B-ALL relapse after CART therapy.

Eligibility:

People aged 1 to 25 years with B-ALL who have had CART therapy within the past 42 days. They must never have had a blood stem cell transplant; they must also have no measurable blood cancer cells.

Design:

Participants will visit the clinic every 2 weeks starting 42 days after they receive CART therapy. Each visit will be about the same amount of time as a regular clinic visit. about 8 hours.

Participants will have blood drawn for testing on each visit.

Bone marrow biopsy/aspirate will be done during 4 of the visits at routine timepoints after CART. A needle will be inserted to draw a sample of tissue from inside the bone in the hip.

A small amount of blood and tissue will be tested with ClonoSEQ and to evaluate for normal B-cells side by side with the standard tests.

The combined testing may help determine whether participants are eligible for HCT and/or at risk of relapse after CART.

Participants will be in the study for 2 years.

Conditions

B-All

Acute Lymphoblastic Leukemia

Study ID

NCT05621291

Start date

Sep 9, 2026

Status verified date

Jul 20, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 25

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:
  • 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.

Study chairs will determine whether other 4-1BB CART are considered comparable.

  • 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 CRITERIA:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 1/Intervention

Systematic, frequent monitoring intervention to risk stratify pts for risk of relapse postCART

Interventions

NGS testing

antigen immunophenotype agnostic approach for disease detection using blood and bone marrow samples

Primary outcome measure

  • Efficacy of novel biomarker-guided risk based strategy to monitor remission [ Time Frame: baseline to 1 year post CD19 CART infusion ]

Central Contacts and Locations

Central contacts

NCI Ped LeukemiaLymph Cell Tx Tm

(240) 760-6970ncilltct@mail.nih.gov

Alexandra Dreyzin, M.D.

(301) 451-4801alexandra.dreyzin@nih.gov

Locations

Children's Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Emily Hsieh, M.D.

Not Listedehsieh@chla.usc.edu

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Anant Vatsayan, M.D.

202-476-2051avatsayan@childrensnational.org

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

Huntsman Cancer Institute, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Michael Pulsipher, M.D.

801-662-4700michael.pulsipher@hci.utah.edu

Seattle Children's, University of Washington

Recruiting

Seattle, Washington, United States, 98105

Contacts

Corine Summers, M.D.

Not Listedcorinnes@uw.edu

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Cindy Hirano

Not Listedchirano@fredhutch.org

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 4, 2026

Last verified

Jul 20, 2026

Keywords

  • B-All
  • Car-Cure
  • Result Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-04.