CancerNCT06377202
Long-Term Follow-Up Safety Study of Subjects Treated with SynKIR-110 in Cancer Studies
An observational study of Cancer, run by Verismo Therapeutics at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the long-term safety of SynKIR- 110 administered to adult subjects with solid tumors expressing mesothelin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 15 Dec 2038
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who recieved SynKIR-110
Who may be able to join
- Subjects who have received any amount of SynKIR-110 in a study sponsored by Verismo Therapeutics.
- Adult 18 years of age or older
Who cannot join
- Unable or unwilling to provide written informed consent
- Unable or unwilling to comply with the study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Long-Term Follow-Up Safety Study of Subjects Treated with SynKIR-110, Autologous T Cells Transduced with Mesothelin KIR-CAR, in Cancer Studies
The primary objective of this study is to evaluate the long-term safety of SynKIR- 110 administered to adult subjects with solid tumors expressing mesothelin.
Read the detailed description
This study has been designed in adherence with the following Food and Drug Administration (FDA) Guidance documents for Industry: the January 2020 Long-Term Follow-Up After Administration of Human Gene Therapy Products; the January 2020 Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; and the March 2022 Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products. The study serves to collect data on delayed adverse events for up to fifteen (15) years following a single infusion of SynKIR-110 administered to advance cancer patients with mesothelin expressing tumors.
For subjects who have not progressed and have rolled onto this LTFU study at 12 months, data on long-term clinical activity will be collected from the subject's standard of care treatment/medical records.
Safety monitoring for delayed adverse events related to SynKIR-110 will include physical examinations, laboratory assessments including complete blood counts, complete metabolic profile, RCL testing and testing for persistence of lentiviral mediated T cells.
Testing for persistence of vector sequences by PCR in subjects' blood (and possibly other surrogate tissue) samples will be done at intervals no greater than 6 months for the first five years and then no greater than annually for the next 10 years, or until such time that no vector sequences are detectable in the subjects' sample.
Subject samples will be collected for RCL (qPCR for VSV-G) assessment at 3, 6, and 12 months after SynKIR-110 infusion and yearly for up to fifteen (15) years. If all RCL tests within the first year are negative for an individual patient, collection of the yearly follow-up samples may be discontinued for that individual.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with treatment related adverse events as assessed by CTCAE v5.0
Monitor for signs of SynKIR-110 related delayed adverse events
Measured: 15 years from date subject received SynKIR-110
Secondary outcomes (2)
Number of subjects with persistence of SynKIR-110 modified cells
Monitor qPCR of peripheral blood for persistence of SynKIR-110 modified T cells.
Measured: 15 years from date subject received SynKIR-110
Number of subjects with potential/suspected RCL
Monitor qPCR of peripheral blood for VSV-G DNA
Measured: 15 years from date subject received SynKIR-110
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start15 Nov 2023
- Primary completion15 Dec 2038 (estimated)
- Study completion15 Dec 2038 (estimated)
Why it stopped: The study is being withdrawn and replaced by a new multicenter LTFU Basket Study, designed to monitor the long-term safety of all SynKIR CAR T cell products. This updated study will include all participants who have been treated with Verismo Therapeu
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verismo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Johnson, PhD, Study director, Verismo Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377202
- Sponsor's protocol ID
- SynKIR-110 LTFU
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up Safety Study of Subjects Treated with SynKIR-110, Autologous T Cells Transduced with Mesothelin KIR-CAR, in Cancer Studies
- ClinicalTrials.gov ID
- NCT06377202
- Acronym / sponsor ID
- SynKIR-110 LTFU
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study is being withdrawn and replaced by a new multicenter LTFU Basket Study, designed to monitor the long-term safety of all SynKIR CAR T cell products. This updated study will include all participants who have been treated with Verismo Therapeu
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Verismo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Dec 2038 (estimated)
- Study completion
- 15 Dec 2038 (estimated)
- First posted
- 22 Apr 2024 (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.
The primary objective of this study is to evaluate the long-term safety of SynKIR- 110 administered to adult subjects with solid tumors expressing mesothelin.
Detailed description
This study has been designed in adherence with the following Food and Drug Administration (FDA) Guidance documents for Industry: the January 2020 Long-Term Follow-Up After Administration of Human Gene Therapy Products; the January 2020 Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; and the March 2022 Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products. The study serves to collect data on delayed adverse events for up to fifteen (15) years following a single infusion of SynKIR-110 administered to advance cancer patients with mesothelin expressing tumors.
For subjects who have not progressed and have rolled onto this LTFU study at 12 months, data on long-term clinical activity will be collected from the subject's standard of care treatment/medical records.
Safety monitoring for delayed adverse events related to SynKIR-110 will include physical examinations, laboratory assessments including complete blood counts, complete metabolic profile, RCL testing and testing for persistence of lentiviral mediated T cells.
Testing for persistence of vector sequences by PCR in subjects' blood (and possibly other surrogate tissue) samples will be done at intervals no greater than 6 months for the first five years and then no greater than annually for the next 10 years, or until such time that no vector sequences are detectable in the subjects' sample.
Subject samples will be collected for RCL (qPCR for VSV-G) assessment at 3, 6, and 12 months after SynKIR-110 infusion and yearly for up to fifteen (15) years. If all RCL tests within the first year are negative for an individual patient, collection of the yearly follow-up samples may be discontinued for that individual.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who recieved SynKIR-110
Key inclusion criteria (2 listed)
- Subjects who have received any amount of SynKIR-110 in a study sponsored by Verismo Therapeutics.
- Adult 18 years of age or older
Key exclusion criteria (2 listed)
- Unable or unwilling to provide written informed consent
- Unable or unwilling to comply with the 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.
Primary outcome
Number of subjects with treatment related adverse events as assessed by CTCAE v5.0
Time frame: 15 years from date subject received SynKIR-110
Monitor for signs of SynKIR-110 related delayed adverse events
2 secondary outcomes
Number of subjects with persistence of SynKIR-110 modified cells
Time frame: 15 years from date subject received SynKIR-110
Number of subjects with potential/suspected RCL
Time frame: 15 years from date subject received SynKIR-110
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Laura Johnson, PhD study director
Verismo Therapeutics
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 Cancer, run by Verismo Therapeutics 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 7 Nov 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of subjects with treatment related adverse events as assessed by CTCAE v5.0 (time frame: 15 years from date subject received SynKIR-110). 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 7 Nov 2024.