Clinical trialNCT03971799Active, not recruitingPhase 1/PHASE2Interventional

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

SponsorCenter for International Blood and Marrow Transplant ResearchEnrollment52Acute Myelogenous Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Nirali Shah, MD, MHSc
National Cancer Institute (NCI)
Principal Investigator
clinicaltrials.gov ↗
Richard Aplenc, MD, PhD
Children's Hospital of Philadelphia
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S Hospital of Los Angeles
Los Angeles, California, United States
Children'S Hospital of Colorado
Aurora, Colorado, United States
National Cancer Institute - Nih
Bethesda, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
the Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Seattle Children'S Hospital/fred Hutchinson Cancer Research Center
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CD33CART allogeneicCD33CART autologous

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 8 Jan 2020
Primary completion: 31 Dec 2029
Completion: 31 Dec 2039
Last update posted: 14 Jul 2025
Registered enrollment: 52
Registry id: NCT03971799

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.