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

• Sponsor: Sorrento Therapeutics, Inc. (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05472649
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Anticipated Duration (Months): 168.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Long-term Follow-up	Biological: Gene-Modified Cell Therapy

Detailed Description

Study STI-CELL-102 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 Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Long-Term Follow-Up Study of Patient Who Have Received Gene-Modified Cell Therapy Produced by Ex Vivo Transduction of Immune Cells Expressing Viral or Non-Viral Vector in Trials Sponsored by Sorrento Therapeutics, Inc.
• Actual Study Start Date: Jun 16, 2021
• Anticipated Primary Completion Date: Jul 1, 2035
• Anticipated Study Completion Date: Jul 1, 2035

Arms and Interventions

Arm	Intervention/Treatment
Participants exposed to Gene-Modified Cell Therapy	Biological: Gene-Modified Cell Therapy; No investigational cell product will be administered

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must have received any amount of a gene-modified cell therapy produced by ex vivo transduction of immune cells expressing viral or non-viral vectors in a study sponsored by Sorrento Therapeutics, Inc.

Exclusion Criteria:

• Unable or unwilling to provide informed consent or comply with study requirements.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center Clinical Research Unit, University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Sorrento Therapeutics, Inc.

Investigators

• Study Director: Mike Royal, MD, Sorrento Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sorrento Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05472649
• Other Study ID Numbers: STI-CELL-102
• First Posted: Jul 25, 2022
• Last Update Posted: Jul 25, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sorrento Therapeutics, Inc.: long-term follow up

Study Results

No Results Posted as of Jul 25, 2022