CancerNCT06701201
A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product
An observational study of Cancer, run by Verismo Therapeutics at 7 sites in United States.
Trial summary
The primary purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- SynKIR-110 and SynKIR-310
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Jan 2025to Feb 2042
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product in a Verismo Therapeutics parent protocol.
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- All adult participants who have received any amount of SynKIR CAR T cell product in a study sponsored by Verismo Therapeutics.
- Participant is willing and able to comply with the study requirements.
Who cannot join
- There are no specific exclusion criteria.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Colorado Blood Cancer Institute, part of Sarah Cannon Research Institute
Denver, Colorado, 80218
MD Anderson Cancer Center
Houston, Texas, 77030
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
University of Kansas Cancer Center
Westwood, Kansas, 66205
About this study
The primary purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products.
Read the detailed description
This is a study for the Long Term Follow Up for all participants treated with Verismo Therapeutics' SynKIR CAR T cell products in accordance with regulatory guidance. The primary objective of this study is to monitor the long-term safety of SynKIR CAR T cell products.
No investigational product will be administered in this LTFU study. Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product under a Verismo Therapeutics parent protocol. Participants will be invited to enroll into this LTFU study after either early discontinuation from or completion of the parent protocol.
In accordance with regulatory guidelines, this study will follow participants for a period of 15 years following infusion of Verismo Therapeutics' SynKIR CAR T cell product, to monitor for delayed adverse events (AEs), detection of replication competent lentivirus (RCL), and to assess long-term efficacy and persistence of gene-modified T cells.
- Conditions
- Cancer
- Being tested
- SynKIR-110, SynKIR-310
- Keywords
- Cancer, CAR-T, CAR-T Cells, KIR-CAR
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynKIR-110Drug
Autologous T cells Transduced with Mesothelin KIR-CAR
SynKIR-310Drug
Autologous T Cells transduced with CD19 KIR-CAR
| Study group | Role | What they receive |
|---|---|---|
| SynKIR-110 | Participants who previously received SynKIR-110 in an interventional trial Receives: Drug: SynKIR-110 | |
| SynKIR-310 | Participants who previously received SynKIR-310 in an interventional trial Receives: Drug: SynKIR-310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product
Frequency and severity of delayed AEs considered related to SynKIR CAR T cell product
Measured: Up to 15 years from SynKIR CAR T cell product administration
To monitor the long-term safety of participants that have been infused with a SynKIR CAR cell product
Presence of RCL VSV-G DNA
Measured: Up to 15 years from SynKIR CAR T cell product administration
Secondary outcomes (3)
To assess the long-term clinical efficacy of SynKIR CAR T cell product
Overall survival
Measured: Up to 15 years from SynKIR CAR T cell product administration
To assess the long-term clinical efficacy of SynKIR CAR T cell product
Progression-free survival
Measured: Up to 15 years from SynKIR CAR T cell product administration
To assess the persistence of SynKIR-modified T cells
Presence of a SynKIR CAR DNA sequence
Measured: Up to 15 years from SynKIR CAR T cell product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start27 Jan 2025
- Primary completionFeb 2042 (estimated)
- Study completionFeb 2042 (estimated)
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verismo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701201
- Sponsor's protocol ID
- LTFU 101-00
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2024
- Last updated
- 4 Aug 2026
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product
- ClinicalTrials.gov ID
- NCT06701201
- Acronym / sponsor ID
- LTFU 101-00
- Conditions
- Cancer
- Keywords
- Cancer, CAR-T, CAR-T Cells, KIR-CAR
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Verismo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Feb 2042 (estimated)
- Study completion
- Feb 2042 (estimated)
- First posted
- 22 Nov 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 purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products.
Detailed description
This is a study for the Long Term Follow Up for all participants treated with Verismo Therapeutics' SynKIR CAR T cell products in accordance with regulatory guidance. The primary objective of this study is to monitor the long-term safety of SynKIR CAR T cell products.
No investigational product will be administered in this LTFU study. Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product under a Verismo Therapeutics parent protocol. Participants will be invited to enroll into this LTFU study after either early discontinuation from or completion of the parent protocol.
In accordance with regulatory guidelines, this study will follow participants for a period of 15 years following infusion of Verismo Therapeutics' SynKIR CAR T cell product, to monitor for delayed adverse events (AEs), detection of replication competent lentivirus (RCL), and to assess long-term efficacy and persistence of gene-modified T cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SynKIR-110 | – | Drug: SynKIR-110Participants who previously received SynKIR-110 in an interventional trial |
| SynKIR-310 | – | Drug: SynKIR-310Participants who previously received SynKIR-310 in an interventional trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product in a Verismo Therapeutics parent protocol.
Key inclusion criteria (3 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- All adult participants who have received any amount of SynKIR CAR T cell product in a study sponsored by Verismo Therapeutics.
- Participant is willing and able to comply with the study requirements.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria.
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 |
|---|---|---|
| SynKIR-110Autologous T cells Transduced with Mesothelin KIR-CAR | Drug | SynKIR-110 |
| SynKIR-310Autologous T Cells transduced with CD19 KIR-CAR | Drug | SynKIR-310 |
Primary outcome
To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product
Time frame: Up to 15 years from SynKIR CAR T cell product administration
Frequency and severity of delayed AEs considered related to SynKIR CAR T cell product
To monitor the long-term safety of participants that have been infused with a SynKIR CAR cell product
Time frame: Up to 15 years from SynKIR CAR T cell product administration
Presence of RCL VSV-G DNA
3 secondary outcomes
To assess the long-term clinical efficacy of SynKIR CAR T cell product
Time frame: Up to 15 years from SynKIR CAR T cell product administration
To assess the long-term clinical efficacy of SynKIR CAR T cell product
Time frame: Up to 15 years from SynKIR CAR T cell product administration
To assess the persistence of SynKIR-modified T cells
Time frame: Up to 15 years from SynKIR CAR T cell product administration
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 4 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites 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 7 sites 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 3 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product (time frame: Up to 15 years from SynKIR CAR T cell product administration). The study lists 2 primary outcomes in all. 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 4 Aug 2026.