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

Lymphoma Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The primary interventions are a lymphodepleting chemotherapy regimen (fludarabine and cyclophosphamide), followed by a single autologous infusion of CD70-CAR T cells.

Phase I study evaluating three (3) dose levels of CD70-CAR T cells. ;

Related Conditions & MeSH terms

• ALL, Childhood
• AML, Childhood
• Hematologic Malignancy
• Hematologic Neoplasms
• Lymphoma
• MDS
• Neoplasms
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT06326463
• Study type: Interventional
• Source: St. Jude Children's Research Hospital
• Contact: Swati Naik, MBBS
• Phone: 866-278-5833
• Email: referralinfo@stjude.org
• Status: Recruiting
• Phase: Phase 1
• Start date: July 2024
• Completion date: July 1, 2031