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

January 19, 2023 updated by: Sorrento Therapeutics, Inc.

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center Clinical Research Unit, University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who were exposed to 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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term durability of clinical effect of previous treatment with gene-modified cells
Time Frame: 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)
Baseline through end of study (approximately 15 years)
Long-term durability of previous treatment with gene modified cells
Time Frame: Baseline through end of study (approximately 15 years)
Long-term durability as assessed by progression-free survival (PFS)
Baseline through end of study (approximately 15 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorrento Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2021

Primary Completion (Anticipated)

December 1, 2036

Study Completion (Anticipated)

May 1, 2037

Study Registration Dates

First Submitted

July 13, 2022

First Submitted That Met QC Criteria

July 21, 2022

First Posted (Actual)

July 25, 2022

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CGT-LTFU-351

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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