The study purpose is to establish the safety and tolerability of IMA202 product in patients with solid tumors that express melanoma-associated antigen 1 (MAGEA1).
SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and a biopsy for biomarker screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA202 product. MANUFACTURING: IMA202 product will be made from the patient's white blood cells. TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA202 product infusion to improve the duration of time that IMA202 product stays in the body. The patient will be admitted to the hospital during the treatment. After the IMA202 product 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 IMA202 infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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. 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 Würzburg
Würzburg, Bavaria, Germany
Universitätsklinikum Bonn - Medizinische Klinik III
Bonn, North Rhine-Westphalia, Germany
Incidence of adverse events (AE)
Time frame: up to 3 years post treatment
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsklinikum C.-G.-Carus Dresden
Dresden, Saxony, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany