CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
St. Jude Children's Research Hospital
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.
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.
Eligibility
- Age range
- Up to 21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria Age ≤21 years old Relapsed/refractory CD70+ hematological malignancy Relapsed disease: Patients developing recurrent disease after a prior complete remission (CR) Refractory disease: Patients with persistent disease despite 3 cycles of induction chemotherapy. * 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…
Interventions
- DrugFludarabine
40mg/m2, Day -4, -3 and -2
- DrugCyclophosphamide
Day -3 and Day-2 REST DAY, -1
- DrugCD70-CAR T cell infusion (Autologous)
Day 0 or +1
- DrugMesna
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
Location
- St. Jude Children's Research HospitalMemphis, Tennessee