Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product

Study Overview
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Brief Summary
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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.

Official Title
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Long-Term Follow-Up Study of Subjects Treated With an Autologous T Cell Product Expressing an Antibody-Coupled T-Cell Receptor (ACTR)

Conditions
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B Cell Lymphomas, Multiple Myeloma, Solid Tumor, HER-2 Protein Overexpression

Intervention / Treatment
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* Other: ACTR T Cell Product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-ACTR<br>Subjects who have previously been treated with an ACTR T cell product | Other: ACTR T Cell Product<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |