Phase I, open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of a single dose of UCART123 (allogeneic engineered T-cells expressing anti-CD123 chimeric antigen receptor), administered in patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
UCART123 (sometimes referred to as the "study product") is a collection of special types of cells called T-cells that have been collected from a healthy donor and then are genetically modified (changed). T-cells are related to your immune system, which help to fight infection. There are 2 parts to this study: (1) dose escalation and (2) dose expansion. The goal of Part 1 of this clinical research study is to test the safety and tolerability of up to 3 different doses of UCART123 and to find the best dose of UCART123 that can be given to patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) including BPDCN that is relapsed (has come back) or refractory (has not responded to treatment). The goal of Part 2 is to learn about the safety and effectiveness of for the best dose of UCART123 that can be given in future studies to patients with BPDCN that is relapsed, or refractory, or newly diagnosed.
Disease Group: Malignant neoplasms stated as primary lymphoid haematopoietic
Treatment Agent: UCART123
Treatment Location: Both at MDACC & and Other Sites
Sponsor: Cellectis S.A.
IRB Review and Approval Date: 05/22/2017
Recruitment Status: Open
Projected Accrual: 72
Information and next steps
Malignant neoplasms stated as primary lymphoid haematopoietic
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