NCT05472649

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
133mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Jun 2021May 2037

Study Start

First participant enrolled

June 16, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
14.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2036

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2037

Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

15.5 years

First QC Date

July 13, 2022

Last Update Submit

January 19, 2023

Conditions

Long-term Follow-up

Keywords

long-term follow up

Outcome Measures

Primary Outcomes (1)

  • Long-term safety of previous treatment with gene-modified cells

    Long-term safety of previous treatment as assessed by incidence of adverse events (AEs)

    Baseline through end of study (approximately 15 years)

Secondary Outcomes (2)

  • 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 previous treatment with gene modified cells

    Baseline through end of study (approximately 15 years)

Study Arms (1)

Participants exposed to Gene-Modified Cell Therapy

Biological: Gene-Modified Cell Therapy

Interventions

Gene-Modified Cell TherapyBIOLOGICAL

No investigational cell product will be administered

Participants exposed to Gene-Modified Cell Therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients must have received any amount of a CGT in a study sponsored by Sorrento Therapeutics, Inc.

You may not qualify if:

  • Unable or unwilling to provide written informed consent and/or comply with study requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center Clinical Research Unit, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Mike Royal, MD

    Sorrento Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 25, 2022

Study Start

June 16, 2021

Primary Completion (Estimated)

December 1, 2036

Study Completion (Estimated)

May 1, 2037

Last Updated

January 23, 2023

Record last verified: 2023-01

Locations

US(1)