ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Phase I, 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

Quick Facts

Study Start:2017-06-19
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03190278

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Contacts and Locations

Principal Investigator

Gail Roboz, Dr
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
United States
Northwestern University
Chicago, Illinois, 60201
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Weill Medical College of Cornell University
New York, New York, 10021
United States
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Cellectis S.A.

  • Gail Roboz, Dr, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-06-19
Study Completion Date2025-12

Study Record Updates

Study Start Date2017-06-19
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Acute Myeloid Leukemia
  • Relapsed/Refractory Acute Myeloid Leukemia
  • Chimeric Antigen Receptor T-Cell (CAR-T) therapy
  • Allogeneic
  • Transcription Activator-Like Effector Nuclease (TALEN)

Additional Relevant MeSH Terms

  • Relapsed/Refractory Acute Myeloid Leukemia