Phase 1, Open Label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART123 (allogeneic engineered T-cells expressing anti-CD123 chimeric antigen receptor), administered in patients with Relapsed/Refractory Acute Myeloid Leukemia, and patients with newly diagnosed high-risk Acute Myeloid Leukemia
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 about 3 different doses of UCART123 and to find the best dose of UCART123 that can be given to patients with acute myeloid leukemia (AML) that is relapsed (has come back) or refractory (has not responded to treatment) or high-risk AML that has not been previously treated. 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 AML 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: 02/27/2018
Recruitment Status: Open
Projected Accrual: 156
Information and next steps
Malignant neoplasms stated as primary lymphoid haematopoietic
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