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CAR T-cell Therapy for Pediatric Blood Cancers

This study is testing a new type of cell therapy called CD70-CAR T cell infusion for children and young adults (up to 21 years old) with certain blood cancers. These cancers include acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), or lymphoma, which have either come back after treatment (relapsed) or haven't responded to standard treatments (refractory). Before receiving the CD70-CAR T cells, participants will get chemotherapy with fludarabine and cyclophosphamide. The main goal is to find the safest and most effective dose of CD70-CAR T cells. The study also aims to see how well this treatment works against the cancer. This study plans to enroll 18 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is a Phase 1 study, evaluating three different dose levels of CD70-CAR T cells.
What's involved
Participants will receive chemotherapy (fludarabine and cyclophosphamide) followed by a single infusion of CD70-CAR T cells.
Compensation
Not stated in the trial record.
Follow-up
The maximum tolerated dose of CD70-CAR T cells will be measured 28 days after the infusion.

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NCT06326463

CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies

Recruiting
PHASE1Up to 21InterventionalTreatment
St. Jude Children's Research Hospital
~18 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:FludarabineCyclophosphamideCD70-CAR T cell infusion (Autologous)Mesna

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose of CD70-CAR T cells
Measured over 28 days after CD70-CAR T-cell infusion

Conditions

Hematologic Malignancy
ALL, Childhood
AML, Childhood
Lymphoma
MDS

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaHematologic NeoplasmLymphomaMixed Phenotype Acute LeukemiaMyelodysplastic SyndromeCD70 Antigen

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Swati Naik, MBBS · PRINCIPAL_INVESTIGATOR · St. Jude

Who to contact

Swati Naik, MBBS
[email protected]
866-278-5833
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Relapsed/refractory CD70+ AML or MDS:
Relapsed disease that is CD70 positive
Refractory disease that is persistent despite 3 cycles of chemotherapy
Relapsed/refractory CD70+ B-cell ALL:
Relapsed disease that is CD70 positive and CD19 negative/dim or patients otherwise ineligible for CD19-directed therapies including:
Patients in 2nd or greater relapse
Patients with relapse after allogeneic HSCT
Relapsed/refractory CD70+ T-cell ALL:
Relapsed /refractory disease that is CD70 positive
Mixed Phenotype Acute Leukemia (MPAL):
Relapsed/refractory that is CD70 positive
Relapsed/refractory CD70+ lymphoma:
Relapsed disease that is CD70 positive and CD19 negative/dim or patients otherwise ineligible for CD19-directed therapies including:
Patients in 2nd or greater relapse
Patients with relapse after allogeneic HSCT

Exclusion

Known primary immunodeficiency
Known history of HIV positivity
Severe intercurrent bacterial, viral or fungal infection
History of hypersensitivity to cornstarch or hydroxyethyl starch
Patients with acute promyelocytic leukemia (APL)
Known contraindication to protocol defined lymphodepleting
chemotherapy regimen of Fludarabine/cyclophosphamide

What this trial measures

  • Maximum tolerated dose of CD70-CAR T cells28 days after CD70-CAR T-cell infusion

    Phase I design to determine the maximum tolerated dose (MTD) of autologous, CD70-CAR T cells. Three (3) dose levels will be evaluated (1x10e6, 3x10e6, and 1x10e7 cells/kg).