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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
375
The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula
The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells
The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula
University of Miami Hospital and Clinics
Miami, Florida, United States
RECRUITINGPhase 1: Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8
Number of patients with dose-limiting toxicities (DLTs)
Time frame: 28 days
Phase 1 and Phase 2: Number and grade of treatment emergent adverse events and adverse events of special interest in subjects treated.
Treatment emergent adverse events (TEAEs), Adverse events of special interest (AESIs) and Treatment-emergent serious adverse events (TESAEs).
Time frame: 35 days
Phase 1 and Phase 2: Tumor Response
Objective response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) centrally assessed (by a BICR1) using RECIST1.1
Time frame: 5 years
Phase 1 and 2: Persistence of TCR engineered T-cells
Measurement of TCR-engineered T cells in peripheral blood
Time frame: up to 5 years post treatment
Phase 1 and 2: Tumor response
Overall response rate, duration of response, disease control rate and progression free survival based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Overall survival.
Time frame: up to 5 years
Phase 2: Patient reported quality of life
Quality of Life questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and EuroQol 5-Dimension 5-Level questionnaire). Higher score indicates worsening of patient's condition.
Time frame: up to 5 years
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Nivolumab will be given post IMA203/IMA203CD8 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb.
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 Immatics clinical trials.
University of Chicago Medical Center
Chicago, Illinois, United States
ACTIVE_NOT_RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGOhio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Columbus, Ohio, United States
RECRUITINGUniversity of Pennsylvania, Perelamn Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
RECRUITINGFox Chase Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
RECRUITINGUniversity of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGUniversitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGKlinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, Germany
RECRUITING...and 6 more locations