The study purpose is to learn about the safety and tolerability of IMA101 alone (Cohort 1) or in combination with atezolizumab (Cohort 2) in patients with advanced solid cancers that express pre-defined Immatics tumor targets.
SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) and the main biomarkers screening. If the patient is eligible, white blood cells will be collected with a leukapheresis for the manufacture of the IMA101 product. MANUFACTURE: IMA101 product will be made from the patient's white blood cells. TREATMENT: IMA101 product will be administered to the patient intravenously after lymphodepleting pre-conditioning with chemotherapy (fludarabine and cyclophosphamide). Low-dose IL-2 will be self-administered twice daily for a total of 28 doses after infusion of IMA101 product. In Cohort 2, atezolizumab will be administered every 3 weeks, starting no earlier than 3 weeks after the IMA101 product infusion and after hematologic recovery. Patients will be monitored closely throughout the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Fludarabine infusion
Cyclophosphamide infusion
i.v. infusion of IMA101 product(s).
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Incidence of adverse events (Safety and tolerability) of IMA101 alone or in combination with atezolizumab
Time frame: up to 18 months
Peripheral T-cell persistence (assessment of frequency of T-cells over time)
Time frame: up to 18 months
Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST)
Time frame: up to 18 months
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Low dose IL-2 Infusion for two weeks
IMADetect is a laboratory test that is part of screening used to determine the mRNA expression of ACTolog target source genes in tumor biopsies from solid tumors. IMADetect is intended for investigational use only.
Atezolizumab infusion will be given no earlier than 3 weeks post IMA101 infusion and after hematologic recovery is achieved, thereafter every 3 weeks until 1 year after IMA101 infusion.