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Business Decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-ACTR | Subjects who have previously been treated with an ACTR T cell product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTR T Cell Product | Other |
|
| 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 |
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Inclusion Criteria
Exclusion Criteria
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Study subjects with disease progression after being treated with at least one dose of an ACTR T cell product in the parent study or other investigational setting
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Sachs, MD | Cogent Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson | Gilbert | Arizona | 85234 | United States | ||
| Mayo Clinic Arizona |
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Blood for replication competent retrovirus (RCR) testing
Remaining biological samples from other protocol procedures (e.g., blood for presence of ACTR+ T cells) may also be stored, at the discretion of the sponsor, for potential future biomarker analyses of T cells, DNA, RNA, and other cells or molecules to study immunology or gene therapy.
Optional blood, bone marrow, and tissue samples also may be collected in the event of a subject's death if an autopsy is performed.
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Loyola University | Maywood | Illinois | 60153 | United States |
| Indiana Bone and Marrow Transplantation | Indianapolis | Indiana | 46237 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Tennessee Oncology - Nashville | Nashville | Tennessee | 37203 | United States |
| Baylor University Medical Center, Charles Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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