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Clinical Trials in the USA / NCT03190278
Active, not recruiting Phase 1

Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT03190278 · tracked via the Priya Life Science USA tracker
Sponsor
Cellectis S.A
Phase
Phase 1
Started
2017-06-19
Last updated
2025-08-07

Condition(s) studied

Relapsed/Refractory Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

UCART123v1.2

UCART123v1.2: Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor Biological/vaccine: CLLS52 A monoclonal antibody that recognizes the CD52 antigen Other Names: Alemtuzumab

Study summary

Phase I, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of Universal Chimeric Antigen Receptor T-cell (UCART) targeting the Cluster of Differentiation 123 (CD123) in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of Universal Chimeric Antigen Receptor T-cells targeting CD123 (UCART123v1.2) and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Main Inclusion Criteria: * Patients with relapsed or primary refractory AML (as defined in World Health Organization \[WHO\] criteria) with ≥5% bone marrow blasts * Patients with CD123+ blast cells (verified by flow cytometry) * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of ≤1 * Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within screening period * (Dose-escalation) Identified donor and transplant strategy prior to lymphodepletion (LD) * Other criteria may apply Main Exclusion Criteria: * Patients with acute promyelocytic leukemia (APL) or central nervous system (CNS) Leukemia * Previous investigation gene or cell therapy (including CAR) * \> 1 prior allogeneic stem cell transplantations (SCTs) * Prior treatment with rituximab or other anti-cluster of differentiation 20 (anti-CD20) therapy within 3 months * Any known active or uncontrolled infection * Other criteria may apply

Primary outcome measure(s)

  • Incidence of adverse events (AE)/serious adverse events (SAE)/Dose Limiting Toxicities (DLT) [Safety and Tolerability] — 24 Months
    Safety of UCART123v1.2 - Incidence, nature, and severity of AE and SAEs throughout the study
  • Dose escalation and expansion part: Occurrence of DLTs — Up to Day 28 post last UCART123v1.2 infusion

Trial sites (8)

FacilityCityRegionStatus
University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center San Francisco California
H. Lee Moffitt Cancer Center & Research Institute Tampa Florida
Northwestern University Chicago Illinois
Dana-Farber Cancer Institute Boston Massachusetts
Roswell Park Cancer Institute Buffalo New York
Weill Medical College of Cornell University New York New York
University of Pennsylvania - Abramson Cancer Center Philadelphia Pennsylvania
MD Anderson Cancer Center Houston Texas

More Cellectis S.A. trials in the USA

Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma Recruiting
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01) Recruiting

Other trials for the same condition

Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03190278 on ClinicalTrials.gov ↗ ← All trials in the USA