NCT06326463

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

Recruiting now Phase 1 Last updated 23 January 2026

What this trial tests

Phase 1 trial testing Fludarabine in Hematologic Malignancy in 18 participants. Currently enrolling.

Timeline

16 October 2024

Primary endpoint
1 July 2030

1 July 2031

Quick facts

Lead sponsor	St. Jude Children's Research Hospital
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	16 October 2024
Primary completion	1 July 2030
Estimated completion	1 July 2031
Sites	1 location across United States

Drugs / interventions tested

• Fludarabine (FLUDARABINE) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• CD70-CAR T cell infusion (Autologous) — full drug profile →
• Mesna (MESNA) — full drug profile →

Conditions studied

• Hematologic Malignancy — all drugs for Hematologic Malignancy →
• ALL, Childhood — all drugs for ALL, Childhood →
• AML, Childhood — all drugs for AML, Childhood →
• Lymphoma — all drugs for Lymphoma →

Sponsor

St. Jude Children's Research Hospital

Who can join

Under 21, any sex, with Hematologic Malignancy or ALL, Childhood. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study participant has one of the following blood cancers: acute myelogenous leukemia (AML)/myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (B-ALL, T-ALL) or Lymphoma. Your cancer has been difficult to treat (refractory) or has come back after treatment (relapse).

Primary Objective

To determine the safety and maximum tolerated dose of intravenous infusions of escalating doses of CD70-CAR T cells in patients (≤21 years) with recurrent/refractory CD70+ hematological malignancies after lymphodepleting chemotherapy.

Secondary Objectives

To evaluate the antileukemic activity of CD70-CAR T cells. We will determine the anti- leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of extramedullary disease.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. CAR-T cell therapy for cancer: current challenges and future directions.
   Zugasti I, Espinosa-Aroca L, Fidyt K, Mulens-Arias V, et al · · 2025 · cited 81× · PMID 40610404 · DOI 10.1038/s41392-025-02269-w
2. Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
   Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6
3. Recent advances of CAR-T cells in acute myeloid leukemia.
   Deng H, Wang Q, Tong X, Cui Z, et al · · 2025 · cited 5× · PMID 40144774 · DOI 10.1177/20406207251326802
4. Mechanisms of Resistance to CAR T-Cells and How to Overcome Them.
   Legato L, Bisio M, Fasano F, Benevolo Savelli C, et al · · 2025 · cited 3× · PMID 40981226 · DOI 10.3390/mps8050108
5. T cell-engaging bispecific antibodies for myeloid malignancies: Targets, formats, and clinical challenges.
   Paczesny S, Barwe SP, Gopalakrishnapillai A, Cheung NV. · · 2026 · PMID 42049030 · DOI 10.1016/j.xcrm.2026.102772
6. Have CARs stalled for non-B-cell malignancies? Where are we, and where are we going?
   Silbert S, Lamble A. · · 2025 · PMID 41347986 · DOI 10.1182/hematology.2025000733