Phase I, Open Label Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART123 Administered in Patients With Relapsed/Refractory AML or Newly Diagnosed High-Risk AML

Clinical Trial Details

This is a clinical trial for adults diagnosed with relapsed (has come back) or refractory (has not responded to treatment) acute myeloid leukemia (AML).

The goal of Phase 1 of this study is to test the safety and tolerability of up to 5 different doses of the investigational medication UCART123 and to find the best dose of UCART123 that can be given to patients with AML that is relapsed or refractory.

UCART123 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) in a laboratory to help kill leukemia cells. T-cells are related to participant's immune system, which helps to fight infection.

UCART123 is an investigational medication. This means that UCART123 is still being studied and has not yet been approved by the U.S. Food and Drug Administration (FDA).

All participants in this study will receive UCART123 given as a slow intravenous infusion (administered directly into the central venous catheter). Participants may receive up to 2 infusions in this study.

Participants are expected to be in this study for up to 15 years, including follow-up.

Key Eligibility:

Open to men and women above the age of 18 who have been diagnosed with relapsed or primary refractory acute myeloid leukemia (AML).
Participants may not receive prior treatment with rituximab or other anti-CD20 therapy within 3 months.

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

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

Primary Investigator(s)

Gail J Roboz, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

1609017585

ClinicalTrials.gov:

NCT03190278

Status

Open to Enrollment

Age Group

Adult

Disease

Leukemia

Acute Lymphocytic Leukemia