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

• Conditions: Long-term Follow-up
• Interventions: Biological: Gene-Modified Cell Therapy

• Registration Number: NCT05472649
• Lead Sponsor: Sorrento Therapeutics, Inc.

Brief 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.

Study Timeline

• Study Start: 2021-06-16
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-23
• Primary Completion: 2036-12
• Study Completion: 2037-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants exposed to Gene-Modified Cell Therapy	Gene-Modified Cell Therapy	-

Primary Outcome Measures

Name	Time	Method
Long-term safety of previous treatment with gene-modified cells	Baseline through end of study (approximately 15 years)	Long-term safety of previous treatment as assessed by incidence of adverse events (AEs)

Secondary Outcome Measures

Name	Time	Method
Long-term durability of previous treatment with gene modified cells	Baseline through end of study (approximately 15 years)	Long-term durability as assessed by progression-free survival (PFS)
Long-term durability of clinical effect of previous treatment with gene-modified cells	Baseline through end of study (approximately 15 years)	Long-term durability of clinical effect of previous treatment with gene-modified cells as assessed by duration of response (DOR)

Trial Locations

Locations (1)

Abramson Cancer Center Clinical Research Unit, University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States