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This study will evaluate the long-term safety and efficacy of CRISPR CAR T cellular therapies
All subjects with hematological and solid malignancies who are enrolled in a parent study and were exposed to allogeneic CRISPR CAR T cellular therapy will be asked to participate in this long-term follow-up (LTFU) study. Subjects who have completed the parent study for the protocol-defined duration, or who have discontinued the parent study early, or who are in secondary follow-up (follow up of subjects with progressive disease or who receive a subsequent line of anticancer therapy) in the parent study may enroll in this LTFU study. This will allow for collection of long-term efficacy data (as applicable) and safety data up to 15 years post-treatment with CRISPR CAR T cellular therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non Interventional | All subjects with hematological and solid malignancies who are enrolled in a parent study and were exposed to allogeneic CRISPR CAR T cellular therapy will be asked to participate in this long-term follow-up (LTFU) study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Interventional | Other | Safety and Efficacy Assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events, serious adverse events and adverse events of special interest related to CRISPR CAR T cellular therapy treatment. | The number and percentage of subjects with CRISPR CAR T cellular therapy related SAEs and AESIs will be summarized. | 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment | Overall survival will be calculated as the time between the initial dose of CRISPR CAR T cellular therapy in the parent study and death due to any cause. Duration of remission/response will be calculated as the time between the first objective response to first disease progression or death due to any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects with hematological and solid malignancies who are enrolled in a parent study and were exposed to allogeneic CRISPR CAR T cellular therapy will be asked to participate in this long-term follow-up (LTFU) study. Subjects who have completed the parent study for the protocol-defined duration, or who have discontinued the parent study early, or who are in secondary follow-up (follow up of subjects with progressive disease or who receive a subsequent line of anticancer therapy) in the parent study may enroll in this LTFU study. This will allow for collection of long-term efficacy data (as applicable) and safety data up to 15 years post-treatment with CRISPR CAR T cellular therapies.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Cedars Sinai |
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| 15 years |
| Los Angeles |
| California |
| 90048 |
| United States |
| Stanford | Stanford | California | 94305 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Emory | Atlanta | Georgia | 30322 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Kansas | Westwood | Kansas | 66205 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Washington University Saint Louis | St Louis | Missouri | 63110 | United States |
| MSKCC | New York | New York | 10065 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Methodist Hospital-Sarah Cannon | San Antonio | Texas | 78229 | United States |
| University of Utah-Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Peter MacCallum Cancer Center | Melbourne | Victoria | 3000 | Australia |
| Sir Charles Gairdner | Nedlands | 6009 | Australia |
| Princess Margaret | Toronto | Ontario | M5G 2M9 | Canada |
| University Hospital Hamburg-Eppendorf | Hamburg | D-20246 | Germany |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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