Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

Miltenyi Biotec

Status: Enrolling

Conditions: Non Hodgkin Lymphoma

Treatments: Other: Long-term Follow-Up

Study type: Observational

Funder types: Industry

Identifiers

NCT06116110

M-2023-401

Details and patient eligibility

About

This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Received zamtocabtagene autoleucel in a Miltenyi Biomedicine-sponsored clinical study and have either completed the study or have discontinued early from the study.
• Provided written informed consent to participate in this study.

Exclusion criteria

• None

Trial design

150 participants in 1 patient group

Long-term Follow-Up

Description:

No intervention

Treatment:

Other: Long-term Follow-Up