Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/17/2018 |
| Start Date: | February 28, 2018 |
| End Date: | December 2047 |
Long Term Follow-up of Subjects Exposed to Genetically Engineered Tumor Antigen Specific T Cell Receptors
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.
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.
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.
Inclusion Criteria:
- Subjects must have received T cell receptor therapy in an Adaptimmune clinical study
- Subjects who have provided informed consent prior to their study participation
Exclusion Criteria:
We found this trial at
3
sites
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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