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Enrolling by invitation NCT05472649

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

— Observational Long-term Follow-up

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gene-Modified Cell Therapy.
Who it may be relevant to
Registry conditions: Long-term Follow-up. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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.

Interventions

  • Biological Gene-Modified Cell Therapy
    No investigational cell product will be administered

Primary outcome measures

  • Long-term safety of previous treatment with gene-modified cells [Time frame: Baseline through end of study (approximately 15 years)]
Secondary outcome measures (2)
  • 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 previous treatment with gene modified cells [Time frame: Baseline through end of study (approximately 15 years)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • Abramson Cancer Center Clinical Research Unit, University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT05472649 · CGT-LTFU-351

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗