ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
Start Date
5/14/2019
Completion Date
6/1/2032
Summary
The study's purpose is to establish the safety and tolerability of IMA203/IMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).
Detailed Description
SCREENING: Patient eligibility will be determined by protocol inclusion/exclusion criteria including HLA (human leukocyte antigen) screening and a biopsy (or collection of archival tumor tissue) for biomarker screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of IMA203 or IMA203CD8 product. MANUFACTURING: IMA203 or IMA203CD8 products will be made from the patients' white blood cells. TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA203/IMA203CD8 product infusion to improve the duration of time that IMA203/IMA203CD8 product stays in the body. The patient will be admitted to the hospital during the T-cell infusion. After the IMA203/IMA203CD8 product infusion, if applicable, a low dose of IL-2 will be given subcutaneously until day 10. In Extension Cohort B (IMA203) nivolumab will be administered intravenously. Patients will be monitored closely throughout the study. The follow-up phase ends 5 years post infusion.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
IMA203 Product
IMA203 product- flat dose
IMA203CD8 Product
Nivolumab
IMADetect®
Conditions
Locations
Stanford Cancer Institute
Stanford, California 94305
United States
University of Colorado, Anschutz Medical Campus
Aurora, Colorado 80045
United States
University of Miami Hospital and Clinics
Miami, Florida 33136
United States
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Columbus, Ohio 43026
United States
University of Pennsylvania, Perelamn Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University, Honickman Center
Philadelphia, Pennsylvania 19107
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Baden-Wurttemberg 69120
Germany
Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria 81675
Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria 97080
Germany
Universitätsklinikum Bonn - Medizinische Klinik III
Bonn, North Rhine-Westphalia 53127
Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate 55131
Germany
Universitätsklinikum C.-G.-Carus Dresden
Dresden, Saxony 01307
Germany
Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie
Berlin, 12203
Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Germany