Long-Term Follow-Up Study of Patients Who Have Received Gene-Modified Cell Therapy or Gene Therapy in Trials Sponsored By Sorrento Therapeutics, INC.

Sorrento Therapeutics, Inc.

Summary

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.

Description

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.

Eligibility

Age range: Not specified
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Patients must have received any amount of a CGT in a study sponsored by Sorrento Therapeutics, Inc. Exclusion Criteria: * Unable or unwilling to provide written informed consent and/or comply with study requirements.

Interventions

Biological
Gene-Modified Cell Therapy
No investigational cell product will be administered

Location

Abramson Cancer Center Clinical Research Unit, University of Pennsylvania
Philadelphia, Pennsylvania