The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 and/or 8 (MAGEA4/8).
SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and the biomarkers screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA201 product. MANUFACTURING: IMA201 product will be made from the patient's white blood cells. TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA201 infusion to improve the duration of time that IMA201 stays in the body. After IMA201 infusion, a low dose of IL-2 will be given twice daily for a period of time. Patients will be closely monitored for safety and for a total of 3 years post IMA201 infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in clinical trials with investigational IMA201 therapy. IMADetect® is intended for investigational use only.
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Universitätsklinikum Bonn, Venusberg-Campus 1
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Carl Gustav Carus, Fetscherstr. 74
Dresden, Saxony, Germany
Incidence of adverse events (AE)
Time frame: up to 3 years post-treatment
Determination of the maximum tolerated dose (MTD)
Time frame: until 21 days post treatment
Duration of infused T cells over time (Persistence of T cells)
Time frame: up to 3 years post-treatment
Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST)
Time frame: up to 12 months
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Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany