Subjects who previously took part in an Adaptimmune study and received genetically changed T cells (including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T) are asked to take part in this long term follow-up study. Subjects will be asked to join this study once they complete the parent interventional study. The purpose of this study is to find out if the genetically changed T cells that subjects received in the parent study have any long-term side effects. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. For a period of 15 years starting from last administration of the genetically changed T cells, subjects will visit their study doctor for a check-up and to have blood tests to look for any changes that might have happened because of the genetically changed T cells.
This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have received lentivirus-mediated genetically engineered T Cell Receptors in an Adaptimmune sponsored clinical trial. The study is designed in accordance with FDA and EMA guidance on gene therapy trials. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Adaptimmune clinical studies. The study will include subjects who have received various T cell receptors including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.
Study Type
OBSERVATIONAL
Enrollment
2
No study drug is administered in this study. Subjects who received lentivirus-mediated genetically engineered T Cell Receptors in a previous trial will be evaluated in this trial for long-term safety and efficacy.
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Princess Margaret Cancer Centr
Toronto, Ontario, Canada
Number of subjects with specific Long Term Follow-Up adverse events (AEs), including serious adverse events (SAEs) associated with administration of autologous T cell receptors that have been genetically modified by lentiviral vectors.
* New malignancies * New incidence or exacerbation of a pre-existing neurologic disorder * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder * New incidence of a hematologic disorder * Opportunistic and/or serious infections * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy
Time frame: 15 years post last treatment
Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells
Subjects' peripheral blood samples will be used to evaluate RCL
Time frame: 15 years post last treatment
Persistence of genetically modified cells in the body
Peripheral blood samples will be used to evaluate persistence
Time frame: 15 years post last treatment
Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR
Number of samples positive for vector integration by PCR
Time frame: 15 years post last treatment
Overall Survival (OS) post-infusion
OS defined as the interval between the date of first T cell infusion and date of death due to any cause
Time frame: 15 years post last treatment
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