Long-term Follow-upNCT05472649
Long-Term Follow-Up of Patients Who Received Gene-Modified Cell Therapy
An observational study of Long-term Follow-up, run by Sorrento Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Long-term Follow-up
- What is being tested?
- Gene-Modified Cell Therapy
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2021to May 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients must have received any amount of a CGT in a study sponsored by Sorrento Therapeutics, Inc.
Who cannot join
- Unable or unwilling to provide written informed consent and/or comply with study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Abramson Cancer Center Clinical Research Unit, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
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.
Read the 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.
- Conditions
- Long-term Follow-up
- Being tested
- Gene-Modified Cell Therapy
- Keywords
- long-term follow up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene-Modified Cell TherapyBiological
No investigational cell product will be administered
| Study group | Role | What they receive |
|---|---|---|
| Participants exposed to Gene-Modified Cell Therapy | Not described Receives: Biological: Gene-Modified Cell Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of previous treatment with gene-modified cells
Long-term safety of previous treatment as assessed by incidence of adverse events (AEs)
Measured: Baseline through end of study (approximately 15 years)
Secondary outcomes (2)
Long-term durability of clinical effect of previous treatment with gene-modified cells
Long-term durability of clinical effect of previous treatment with gene-modified cells as assessed by duration of response (DOR)
Measured: Baseline through end of study (approximately 15 years)
Long-term durability of previous treatment with gene modified cells
Long-term durability as assessed by progression-free survival (PFS)
Measured: Baseline through end of study (approximately 15 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start16 Jun 2021
- Primary completionDec 2036 (estimated)
- Study completionMay 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term Follow-upStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Royal, MD, Study director, Sorrento Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472649
- Sponsor's protocol ID
- CGT-LTFU-351
- Status last verified
- Jan 2023
- First submitted
- 13 Jul 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05472649
- Acronym / sponsor ID
- CGT-LTFU-351
- Conditions
- Long-term Follow-up
- Keywords
- long-term follow up
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- Dec 2036 (estimated)
- Study completion
- May 2037 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants exposed to Gene-Modified Cell Therapy | – | Biological: Gene-Modified Cell Therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients must have received any amount of a CGT in a study sponsored by Sorrento Therapeutics, Inc.
Key exclusion criteria (1 listed)
- Unable or unwilling to provide written informed consent and/or comply with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gene-Modified Cell TherapyNo investigational cell product will be administered | Biological | Participants exposed to Gene-Modified Cell Therapy |
Primary outcome
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)
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mike Royal, MD study director
Sorrento Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long-term Follow-up, run by Sorrento Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety of previous treatment with gene-modified cells (time frame: Baseline through end of study (approximately 15 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.