B Cell Lymphomas, HER-2 Protein Overexpression, Multiple Myeloma, Solid Tumor
Conditions
Brief summary
Subjects treated with an ACTR product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. No investigational product or treatment will be administered in this study. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.
Interventions
OTHERACTR T Cell Product
Sponsors
Cogent Biosciences, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 setting to the extent willing and able to do so * Able to comply with study requirements
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term safety of ACTR T cell product as assessed by overall survival | Total of 15 years after first receiving an ACTR T cell product |
| Long-term safety of ACTR T cell product as assessed by serious adverse events related to ACTR T cell product | Total of 15 years after first receiving an ACTR T cell product |
| Long-term safety of ACTR T cell product as assessed by Grade 3 or 4 adverse events related to ACTR T cell product | Total of 15 years after first receiving an ACTR T cell product |
| Long-term safety of ACTR T cell product as assessed by adverse events of special interest, regardless of grade or relatedness to the ACTR T cell product | Total of 15 years after first receiving an ACTR T cell product |
| ACTR T cell persistence in subjects previously treated with an ACTR T cell product | Total of 15 years after first receiving an ACTR T cell product |
Countries
United States
Outcome results
None listed