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

Sorrento Therapeutics

Status: Invitation-only

Conditions: Long-term Follow-up

Treatments: Biological: Gene-Modified Cell Therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT05472649

CGT-LTFU-351

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 estimated patient

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

1 participants in 1 patient group

Participants exposed to Gene-Modified Cell Therapy

Treatment:

Biological: Gene-Modified Cell Therapy