Participants Treated With Senza5NCT07683897
A Long-Term Follow-Up Trial for Participants Enrolled in CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) Trials
An observational study of Participants Treated With Senza5, run by Vittoria Biotherapeutics.
Trial summary
This is an open label, multi-center, long-term safety and efficacy follow-up trial for participants who have been treated with Senza5 CART5. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Participants Treated With Senza5
- What is being tested?
- Senza5 CART5
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jul 2041
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: Participants treated with Senza5 CART5 who have met all eligibility criteria and provided written informed consent for LTFU-Viper 101 (or have written informed consent from their parent[s]/legal guardian[s] and have provided assent, as applicable).
Who may be able to join
None listed.
Who cannot join
- There are no exclusion criteria.
About this study
This is an open label, multi-center, long-term safety and efficacy follow-up trial for participants who have been treated with Senza5 CART5.
Read the detailed description
This is an open label, multi-center, long-term safety and efficacy follow-up trial for participants who have been treated with Senza5 CART5. The US Food and Drug Administration (FDA 2018) and European Medicines Agency (EMA 2009) recommend long-term follow-up (LTFU) for participants treated with gene therapy drug products to monitor for selected adverse events (AEs) as well as durability of clinical response (FDA Guidance 2020).
Participants enrolled in LTFU-Viper101 will be followed every 6 months through 5 years following Senza5 CART5 infusion, then annually through 15 years.
Vector copy number (VCN) will be measured at designated time points during scheduled trial visits.
Safety evaluations to be performed during the trial include, but are not limited to, physical examinations; documentation of serious adverse events (SAEs), drug product-related adverse events (AEs), serious or non-serious immune-related AEs (e.g., autoimmune disorders, graft-versus-host disease [GVHD], opportunistic infections, human immunodeficiency virus [HIV]), new or worsening hematologic or neurologic disorders (as determined by the Investigator), and malignancies; long-term surveillance for evidence of replication competent lentivirus (RCL); and characterization of events of insertional mutagenesis leading to clonal dominance or oncogenesis.
- Conditions
- Participants Treated With Senza5
- Being tested
- Senza5 CART5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senza5 CART5Biological
Senza5 CART5
What is being measured
The primary outcome is the main question the study is designed to answer.
All drug product-related AEs
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2041 (estimated)
- Study completionJul 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Participants Treated With Senza5Studies 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
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vittoria Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683897
- Sponsor's protocol ID
- Viper 101 LTFU
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Follow-Up Trial for Participants Enrolled in CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) Trials
- ClinicalTrials.gov ID
- NCT07683897
- Acronym / sponsor ID
- Viper 101 LTFU
- Conditions
- Participants Treated With Senza5
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vittoria BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2041 (estimated)
- Study completion
- Jul 2041 (estimated)
- First posted
- 6 Jul 2026 (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.
This is an open label, multi-center, long-term safety and efficacy follow-up trial for participants who have been treated with Senza5 CART5.
Detailed description
This is an open label, multi-center, long-term safety and efficacy follow-up trial for participants who have been treated with Senza5 CART5. The US Food and Drug Administration (FDA 2018) and European Medicines Agency (EMA 2009) recommend long-term follow-up (LTFU) for participants treated with gene therapy drug products to monitor for selected adverse events (AEs) as well as durability of clinical response (FDA Guidance 2020).
Participants enrolled in LTFU-Viper101 will be followed every 6 months through 5 years following Senza5 CART5 infusion, then annually through 15 years.
Vector copy number (VCN) will be measured at designated time points during scheduled trial visits.
Safety evaluations to be performed during the trial include, but are not limited to, physical examinations; documentation of serious adverse events (SAEs), drug product-related adverse events (AEs), serious or non-serious immune-related AEs (e.g., autoimmune disorders, graft-versus-host disease [GVHD], opportunistic infections, human immunodeficiency virus [HIV]), new or worsening hematologic or neurologic disorders (as determined by the Investigator), and malignancies; long-term surveillance for evidence of replication competent lentivirus (RCL); and characterization of events of insertional mutagenesis leading to clonal dominance or oncogenesis.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants treated with Senza5 CART5 who have met all eligibility criteria and provided written informed consent for LTFU-Viper 101 (or have written informed consent from their parent[s]/legal guardian[s] and have provided assent, as applicable).
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- There are no 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 |
|---|---|---|
| Senza5 CART5Senza5 CART5 | Biological | – |
Primary outcome
All drug product-related AEs
Time frame: 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 30 Jul 2026.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Participants Treated With Senza5, run by Vittoria Biotherapeutics.
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 0 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: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
All drug product-related AEs (time frame: 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 30 Jul 2026.