NCT06326463: CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies

Study 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.

Interventions

FludarabineDRUG

40mg/m2, Day -4, -3 and -2

CyclophosphamideDRUG

Day -3 and Day-2 REST DAY, -1

CD70-CAR T cell infusion (Autologous)DRUG

Day 0 or +1

MesnaDRUG

Mesna is generally dosed at approximately 25% of the cyclophosphamide dose. It is generally given intravenously prior to and again at 3, 6 and 9 hours following each dose of cyclophosphamide

Study Locations

Facility	City	State	Country
St. Jude Children's Research Hospital	Memphis	Tennessee	United States

Official Trial Information

View on ClinicalTrials.gov