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Observational long-term follow-up study of patients who have been exposed to a gene-modified cell therapy produced by ex vivo transduction of immune cells expressing viral or non-viral vectors in studies sponsored by Sorrento Therapeutics, Inc.
Study CGT-LTFU-35 is an observational study of patients who have been exposed to a gene-modified cell therapy (GMCT) produced by ex vivo transduction of immune cells expressing viral and/or non-viral vectors in studies sponsored by Sorrento Therapeutics, Inc. Patients are to be followed for up to 15 years after exposure to a GMCT agent for the possible development of long-term adverse events and efficacy outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants exposed to Gene-Modified Cell Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gene-Modified Cell Therapy | Biological | No investigational cell product will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety of previous treatment with gene-modified cells | Long-term safety of previous treatment as assessed by incidence of adverse events (AEs) | Baseline through end of study (approximately 15 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term durability of clinical effect of previous treatment with gene-modified cells | Long-term durability of clinical effect of previous treatment with gene-modified cells as assessed by duration of response (DOR) | Baseline through end of study (approximately 15 years) |
| Long-term durability of previous treatment with gene modified cells |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who were exposed to gene-modified cell therapy produced by ex vivo transduction of immune cells expressing viral or non-viral vectors in studies sponsored by Sorrento Therapeutics, Inc.
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| Name | Affiliation | Role |
|---|---|---|
| Mike Royal, MD | Sorrento Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center Clinical Research Unit, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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Long-term durability as assessed by progression-free survival (PFS) |
| Baseline through end of study (approximately 15 years) |