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

Phase 1

Recruiting

• Conditions: ALL, Childhood; MDS; AML, Childhood; Hematologic Malignancy; Lymphoma
• Interventions: Drug: Fludarabine; Drug: Cyclophosphamide; Drug: CD70-CAR T cell infusion (Autologous); Drug: Mesna

• Registration Number: NCT06326463
• Lead Sponsor: St. Jude Children's Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-22
• Study Start: 2024-10-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17
• Primary Completion: 2030-07-01
• Study Completion: 2031-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD70- CAR T cell Therapy	Cyclophosphamide	Patients will receive autologous (their own) cells.
CD70- CAR T cell Therapy	CD70-CAR T cell infusion (Autologous)	Patients will receive autologous (their own) cells.
CD70- CAR T cell Therapy	Fludarabine	Patients will receive autologous (their own) cells.
CD70- CAR T cell Therapy	Mesna	Patients will receive autologous (their own) cells.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of CD70-CAR T cells	28 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).

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States