NCT05472649

Long-Term Follow-Up of Patients Who Received Gene-Modified Cell Therapy

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1 (estimated)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Long-term Follow-up

Interventions

Type	Name	Description
BIOLOGICAL	Gene-Modified Cell Therapy	No investigational cell product will be administered

Timeline

• Start date: 2021-06-16
• Primary completion: 2036-12-01
• Completion: 2037-05-01
• First posted: 2022-07-25
• Last updated: 2023-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study