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Phase I, open label dose-escalation and expansion study to evaluate the safety, proliferation, persistence and clinical activity of a single dose of UCART123, in patients with Relapsed/Refractory AML, and patients with high-risk newly diagnosed AML

Clinical Trial Details

UCART123 (referred to as the “study product” or “UCART123 cells”) is a new, investigational form of leukemia therapy in which healthy immune system cells, called T cells, are taken from healthy donors (these are called allogeneic T cells) and specially engineered in the laboratory to be able to target a molecule on the surface of leukemia cells called CD123. Preliminary data from animal studies have suggested that this process can generate allogeneic T cells that could be highly active against AML cells that express CD123. If the study product is given to a patient with AML, it is hoped that the T cells will be able to destroy the CD123 positive leukemia cells and lead to remission in selected patients with AML. In case the study product is causing side effects, the study product has been engineered to allow it to be destroyed by administering a drug called Rituximab. 

Key Eligibility: 
  • Open to men and women above the age of 18 with Relapsed/Refractory Acute Myeloid Leukemia, or with newly diagnosed high-risk Acute Myeloid Leukemia 
  • Participants must have AML Blast cells expressing CD123, and must not have had previous treatment with investigational gene or chimeric antigen receptor therapy, or rituximab and other anti-CD20 antibodies 
  • Detailed eligibility will be reviewed when you contact the study team 

Contact

Tania Curcio FNP-BC
tjc9003@med.cornell.edu
(212)-746-2571

Primary Investigator

Gail J. Roboz, M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1609017585

Sponsor:

UCART123_01

Status:

Not Yet Recruiting

Age Group

Adult

Sponsor

Drug/Device

Drug

Study Type

Phase

1