The study objectives are to evaluate long-term safety and ACTR T cell persistence in subjects previously treated with an ACTR T cell product.
- Willing to provide informed consent for participation in the study
- Received at least 1 dose of an ACTR T cell product in an investigational or other treatment setting such as compassionate use, named patient IND, expanded access program, or equivalent settings
- Has completed study assessments and follow-up visits in the prior study or other investigational settings, such as compassionate use, named patient IND, expanded access program, or equivalent settings to the extent willing and able to do so.
- Unable to comply with study requirements
- Unwillingness to provide informed consent for participation in the study
This study is being done to see if there are any long-term or delayed side effects associated with the ACTR T cell product which you received as part of the main study (Protocol Number ATTCK-17-01) including any possible side effects that may occur if the ACTR binds to antibodies that may be present in your body.
The study will also look to see how long the ACTR can be detected in your blood and to test to see if the virus used in making the ACTR is being copied in your body. Because a virus was used to put new genetic material into the ACTR T cells, it is important (and the US Food and Drug Administration requires) that your overall progress is monitored to look for any possible long-term or delayed side effects.
To be in this long-term follow up study, you must have previously been treated with an ACTR T cell product.
You will be in the long-term follow up study for up to 15 years after your ACTR T cell product was infused. During this time, you will be expected to attend all study visits as scheduled. More information on the tests performed at each visit is provided later in this document.
For the first 5 years after ACTR T cell product infusion, visits in this follow-up study will be scheduled at regular intervals. The intervals between visits will vary depending on the length of time you were on the previous ACTR study and when you enroll in this study.
At these visits, you will have routine blood tests (about 1 tablespoon, 15 mL) to measure your blood counts (numbers of each type of blood cell) and to check levels of antibodies (called immunoglobulins). Approximately 2-3 tablespoons (30-45 mL) of blood will also be obtained to check if the ACTR T cell product has remained in your body and to check for copies of the virus that was used in making the ACTR T cell product. If copies of the virus used in making the ACTR T cell product is seen in your blood, additional blood sampling will be required.
After the first 5 years after ACTR T cell product infusion, visits will be scheduled once a year up to year 15. At each visit, you will have a blood sample to assess if the ACTR T cell product is still in your body (approximately 1-2 tablespoons or 15-30 mL) and a blood test (about l tablespoon or 15 mL) to check for copies of the retrovirus used in making the ACTR T cell product.