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.
Acute Myelogenous 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 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.
Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia
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Children's Hospital of Los Angeles, Los Angeles, California, United States, 90027
Children's Hospital of Colorado, Aurora, Colorado, United States, 80045
National Cancer Institute - NIH, Bethesda, Maryland, United States, 20892
Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104
Seattle Children's Hospital/Fred Hutchinson Cancer Research Center, Seattle, Washington, United States, 98105
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
1 Year to 35 Years
ALL
No
Center for International Blood and Marrow Transplant Research,
Nirali Shah, MD, MHSc, PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)
Richard Aplenc, MD, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia
2039-12