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

NCT ID: NCT05472649

Last Updated: 2023-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-16

Study Completion Date

2037-05-31

Brief Summary

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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

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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.

Conditions

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Long-term Follow-up

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants exposed to Gene-Modified Cell Therapy

Gene-Modified Cell Therapy

Intervention Type BIOLOGICAL

No investigational cell product will be administered

Interventions

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Gene-Modified Cell Therapy

No investigational cell product will be administered

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sorrento Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mike Royal, MD

Role: STUDY_DIRECTOR

Sorrento Therapeutics, Inc.

Locations

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Abramson Cancer Center Clinical Research Unit, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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CGT-LTFU-351

Identifier Type: -

Identifier Source: org_study_id

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