TCR-engineered T Cells in Solid Tumors With Emphasis on NSCLC and HNSCC (ACTengine)
Phase I Trial Evaluating Genetically Modified Autologous T Cells Expressing a T-Cell Receptor Recognizing a Cancer/Germline Antigen in Patients Having Solid Tumors With Emphasis on NSCLC or HNSCC
Doctors at UT MD Anderson Cancer Center see participants with one of the following types of cancer to receive a clinical trial of a gene-modified immunotherapy treatment to redirect and activate the patient’s own T-cells to treat their cancer.
- Solid Tumor
- Head and Neck Squamous Cell Carcinoma
- Non-small Cell Lung Cancer
The therapy removes the patient’s immune cells and utilizes genetic engineering to activate those cells to recognize their cancer as a target. After multiplying the cells in the lab, they are re-infused to the patient after a cycle of chemotherapy. An additional drug, interleukin-2, will also be administered to encourage the growth of the T-cells. The first 12 months most treatment will require regular assessments (lab and other types), and the patient will be tracked for up to 15 years from the last treatment.
- Meet pathology screenings related to their cancer type/diagnosis
- Have at least one lesion (tumor) able to be biopsied
- Have normal liver function
- Meet required levels of lung, clotting, and immune system function
- Not have a serious autoimmune disease
THE STUDY INVOLVES:
- Screening of the patient’s human leukocyte antigen (HLA) profile for appropriate fit to the study’s needs.
- Leukapheresis to extract the patient’s white blood cells from their blood, which is then used for creation of the genetically engineered and amplified product.
- Chemotherapy to deplete the patient’s remaining immune cells before the engineered product is returned to the patient via transfusion.
- Each participant will be followed for 12 months to track their T-cell levels and T-cell activity as well as overall clinical response of their tumor.
- Follow-up post the first 12 months will be less intensive but continue for at least 15 years.
LOCATIONS AND CONTACTS:
University of Texas MD Anderson Cancer Center in Houston, TX is recruiting participants for this study. Map
Contact: Rebecca Griffith-Eskew | [email protected] | 346-204-5359
Immatics US, Inc. & M.D. Anderson Cancer Center
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