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This study is designed to collect long-term safety and survival data from participants previously treated in an eligible Century-sponsored index trial. This is an observational study, and the elements of the study design allow for important follow-up for safety, survival, and the continued evaluation of any late adverse events (AEs) that may appear after treatment with such cellular products. Additionally, collection of persistence data from participants will support the identification of any long-term risks or late AEs that may be causally related to treatment with such cellular products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cellular Therapy | Participants who have previously received an induced pluripotent stem cell (iPSC)-derived, ex vivo genome edited cellular therapy product in an eligible Century-sponsored index trial will be enrolled in this study for up to 180 months following the last treatment with a cellular therapy product in an eligible index trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | As this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With any Adverse Events of Special Interest (AESI) | Up to 180 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cellular Product-related Serious Adverse Events (SAEs) | Up to 180 months | |
| Overall Survival (OS) | OS is defined as the time from first treatment with a cellular therapy product in the index trial to date of death by any cause. |
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Inclusion Criteria:
Exclusion Criteria:
-This study has no exclusion criteria.
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Participants who have been previously treated with cellular therapy products in an eligible investigational index trial.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Century Therapeutics Clinical Team | Contact | 8885067670 | trial_response_century@centurytx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Not yet recruiting | Gilbert | Arizona | 85234 | United States |
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| From first dose of study drug up to end of the study or death whichever occurs first (up to 180 months) |
| Percentage of Participants With Persistent Product | Persistence of the cellular product will be assessed by a droplet digital polymerase chain reaction molecular test to evaluate transgene copies in the peripheral blood. Summary of persistence sample results (positive/negative) will be reported. | Up to 180 months |
| University of Southern California - Norris Comprehensive Cancer Center | Not yet recruiting | Los Angeles | California | 90033 | United States |
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| University of Maryland Medical Center | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Corewell Health | Not yet recruiting | Grand Rapids | Michigan | 49503 | United States |
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| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| University of Cincinnati Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| Swedish Cancer Institute | Recruiting | Seattle | Washington | 98104 | United States |
|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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