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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05472649

Enrollment

Registered

2022-07-25

Start date

2021-06-16

Completion date

2037-05-31

Last updated

2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term Follow-up

Keywords

long-term follow up

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.

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

BIOLOGICALGene-Modified Cell Therapy

No investigational cell product will be administered

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026