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Enrolling by Invitation

NCT Number: NCT05472649

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

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.

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Key information

Conditions

Long-term Follow-up

Sex eligibility

All sexes

Study type

Observational

Primary location

Abramson Cancer Center Clinical Research Unit, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gene-Modified Cell Therapy

Biological

No investigational cell product will be administered

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Sorrento Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2036
Study completion
2037
First posted
Jul 25, 2022
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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