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

NCT06326463 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-01-23

No results posted yet for this 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.

Conditions

  • Hematologic Malignancy
  • ALL, Childhood
  • AML, Childhood
  • Lymphoma
  • MDS

Interventions

DRUG

Fludarabine

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

DRUG

Cyclophosphamide

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

DRUG

CD70-CAR T cell infusion (Autologous)

Day 0 or +1

DRUG

Mesna

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

Sponsors & Collaborators

Principal Investigators

  • Swati Naik, MBBS · St. Jude

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2030-07-01
Completion
2031-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06326463 on ClinicalTrials.gov