Open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART22 (allogeneic engineered T-cells expressing Anti- D22 Chimeric Antigen Receptor) in patients with relapsed or refractory CD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)
The primary objective of the dose-escalation part of the study is to evaluate the safety and tolerability of UCART22 and, therefore, determine the MTD, if it exists, based on the occurrence of DLTs, and/or determine RP2D. The MTD estimated by the mTPI is the dose level with the highest dose at which the toxicity probability is the closest to the target toxicity probability, among all tested doses not excluded for overtoxicity. Up to 40 subjects will be enrolled in the Dose Escalation phase. The safety stopping rules are described
Adult
Treatment
CTRC Inpatient
University of Colorado Hospital
Marc Schwartz, MD
Protocol Number: 22-1502
More information available at ClinicalTrials.gov: NCT04150497
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