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

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).

Conditions

Relapsed/Refractory Acute Myeloid Leukemia

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Relapsed/Refractory Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States, 94143

Miami

Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Tampa

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States, 33612

Chicago

Northwestern University, Chicago, Illinois, United States, 60201

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Buffalo

Roswell Park Cancer Institute, Buffalo, New York, United States, 14263

New York

Weill Medical College of Cornell University, New York, New York, United States, 10021

Philadelphia

University of Pennsylvania - Abramson Cancer Center, Philadelphia, Pennsylvania, United States, 19104

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cellectis S.A.,

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

Study Record Dates

2024-12