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
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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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

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Exclusion Criteria

Not provided

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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