Spots Global Cancer Trial Database for Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL
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Trial Identification
Brief Title: Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL
Official Title: Phase 2 Study of Humanized CD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19) for Very High-Risk Subsets of B Cell Acute Lymphoblastic Leukemia (B-ALL)
Study ID: NCT03792633
Conditions
Interventions
Study Description
Brief Summary: This is a phase 2 study to evaluate humanized CD19 redirected autologous T cells (or huCART19 cells) with CD19 expressing relapsed and refractory B-cell acute lymphoblastic leukemia. This study is targeting pediatric and young adult patients aged 1-29 years with CD19+ B cell malignancies in newly diagnosed B-ALL patients predicted to have an exceedingly poor outcome with conventional chemotherapy, in high-risk first relapse, or and in second or greater relapse in this phase 2 trial. In addition, a second cohort will test the efficacy of huCART19 in patients with poor response to prior B cell directed engineered cell therapy.
Detailed Description:
Keywords
Eligibility
Minimum Age: 3 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Pennsylvania, Philadelphia, Pennsylvania, United States
Contact Details
Name: Shannon Maude, MD, PhD
Affiliation: Children's Hospital of Philadelphia
Role: PRINCIPAL_INVESTIGATOR
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