Trials / Recruiting
RecruitingNCT06116110
Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Miltenyi Biomedicine GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
Detailed description
This is a non-therapeutic study design. After successful screening, subjects will be monitored for potential gene therapy-related adverse events for up to 15 years post MB-CART2019.1 infusion. Subjects will be assessed yearly for the occurrence of delayed adverse events (AEs), monitored for replication competent lentivirus (RCL) and assessed for long term efficacy as well as CAR-T persistence.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Long-term Follow-Up | No intervention |
Timeline
- Start date
- 2024-05-15
- Primary completion
- 2039-12-01
- Completion
- 2039-12-01
- First posted
- 2023-11-03
- Last updated
- 2024-11-20
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06116110. Inclusion in this directory is not an endorsement.