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NCT03971799 · ClinicalTrials.gov registry record · Phase 1

Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia

A Phase 1 study of Acute Myelogenous Leukemia, sponsored by Center for International Blood and Marrow Transplant Research.

Active
Registry status
Phase 1
Development phase
52
Enrollment target
6
Study locations

NCT03971799 is a Phase 1 study of Acute Myelogenous Leukemia that is active but no longer recruiting, run by Center for International Blood and Marrow Transplant Research. The registered enrollment target is 52 participants, below the 139-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (63% lower). The trial reports 6 study locations across 6 states.

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The verdict

NCT03971799, a Phase 1 study of Acute Myelogenous Leukemia, is active but no longer recruiting, sponsored by Center for International Blood and Marrow Transplant Research.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
52 participants
Enrollment target
6
Study locations

Study Summary

This phase 1/2 trial aims to determine the safety and feasibility of antiCD33 chimeric antigen receptor (CAR) expressing T cells (CD33CART) in children and adolescents/young adults (AYAs) with relapsed/refractory acute myeloid leukemia (AML). The trial will be done in two phases: Phase 1 will determine the maximum tolerated dose of CD33CART cells using a 3+3 trial design, with dose-escalation for autologous products separated from dose-escalation for an allogeneic arm. Phase 2 is an expansion phase designed to evaluate the rate of response to CD33CART.

Conditions Studied

Acute Myelogenous Leukemia

Interventions

  • BIOLOGICAL CD33CART autologous
  • BIOLOGICAL CD33CART allogeneic

Study Locations (6)

California

  • Children's Hospital of Los Angeles - Los Angeles

Colorado

  • Children's Hospital of Colorado - Aurora

Maryland

  • National Cancer Institute - NIH - Bethesda

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Pennsylvania

  • The Children's Hospital of Philadelphia - Philadelphia

Washington

  • Seattle Children's Hospital/Fred Hutchinson Cancer Research Center - Seattle

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2020-01-08
Est. Completion 2039-12
Phase Phase 1

Sponsor

Center for International Blood and Marrow Transplant Research

29 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03971799

The ClinicalTrials.gov registry entry for NCT03971799 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 139-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (63% lower). The listed sponsor is Center for International Blood and Marrow Transplant Research, which has 29 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Myelogenous Leukemia appearing as the primary indexed condition, and to 2 interventions - of which CD33CART autologous is the first listed.

NCT03971799 reports 6 study locations spanning 6 distinct geographic areas - top geographies include California, Colorado, Maryland.

Frequently Asked Questions

What is clinical trial NCT03971799 about?

NCT03971799 is a clinical study titled "Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia". This phase 1/2 trial aims to determine the safety and feasibility of antiCD33 chimeric antigen receptor (CAR) expressing T cells (CD33CART) in children and adolescents/young adults (AYAs) with relapsed/refractory acute myeloid leukemia (AML). The trial will be done in two phases: Phase 1 will determ...

What is the current status of trial NCT03971799?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2020-01-08. Estimated completion is 2039-12.

What conditions does trial NCT03971799 study?

This clinical trial studies the following conditions: Acute Myelogenous Leukemia.

What interventions are being tested in trial NCT03971799?

The interventions under investigation include: CD33CART autologous (BIOLOGICAL), CD33CART allogeneic (BIOLOGICAL).

Who is sponsoring clinical trial NCT03971799?

This trial is sponsored by Center for International Blood and Marrow Transplant Research, which has 29 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03971799 being conducted?

This trial has 6 study locations across California, Colorado, Maryland, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.