A Long-Term Follow-Up Trial for Participants Enrolled in CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) Trials
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Senza5 CART5.
- Who it may be relevant to
- Registry conditions: Participants Treated With Senza5. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Biological Senza5 CART5
Senza5 CART5
Primary outcome measures
- All drug product-related AEs [Time frame: 15 years]
Eligibility criteria
Inclusion Criteria: Participants meeting the following criteria are eligible for trial participation:
- Provision of written informed consent by the participant or provision of written informed consent from the participant's parent\[s\]/legal guardian\[s\] and provision of assent from the participant, as applicable
- Treated with Senza5 CART5 in a Vittoria BioTherapeutics sponsored clinical trial
- Able to comply with trial requirements
Exclusion criteria
- There are no exclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07683897 · Viper 101 LTFU