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Clinical Trial Summary

This clinical research study investigates IMA201 which is composed of special immune cells (T cells, also called T lymphocytes) being genetically modified by introduction of a tumor-antigen specific T cell receptor (TCR) to fight against cancer. Patients that choose to take part in this study have advanced cancer where there is no (further) standard treatment for their cancer available OR current treatments are not tolerated.

The main purpose of this clinical research study is to confirm the safety of IMA201 and to define the highest safe dose of IMA201 cells to give to patients. The study will also investigate what the specific side effects of this treatment are, and to see whether this therapy shows clinical activity in patients with their advanced cancer.

Clinical Trial Description

SCREENING: First, the patient will have 2 sets of screening tests to determine eligibility: HLA (human leukocyte antigen) screening and Main screening. After both screenings are completed and if the patient is eligible, blood will be taken for the manufacture of IMA201.

The HLA screening test will be done by an investigational device. Patients must have the HLA-A*02:01 subtype to continue to the Main screening of the study. The Main screening will include medical tests and exams, including a tumor biopsy that will be tested for specific biomarkers by an investigational device called IMA201_Detect. Patients must be positive for at least one of the study's biomarkers to continue onto the leukapheresis part of the study.

Manufacturing phase: From the patient's blood collected at the leukapheresis, the investigators will make the IMA201 TCR-engineered T cells. In order to insert the new gene into the patient's T-cells, investigators will use a gene transfer technology. This will be done with a lentiviral vector derived from a virus. The vector was made specifically for this study and will carry the TCR genes into the T cells.

TREATMENT: In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body. Giving chemotherapy before a T cell infusion is called lymphodepletion. The chemotherapy used for lymphodepletion in this study will be a combination of cyclophosphamide and fludarabine which would be given in the days before the IMA201 T cell infusion. Two days after the last chemotherapy dose, the patient will be admitted to the hospital the night before the IMA201 infusion. The IMA201 treatment will be given at MD Anderson Cancer Center.

After IMA201 infusion, a low dose of IL-2 will be given twice daily for a period of time.

Since this study involves gene therapy, patients will be monitored throughout the study and for up to a total of 15 years. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03247309
Study type Interventional
Source Immatics US, Inc.
Contact Hong Ma, M.D.
Phone 346-204-5350
Status Recruiting
Phase Phase 1
Start date September 26, 2017
Completion date December 31, 2033

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