Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

Recruiting

• Conditions: Non Hodgkin Lymphoma
• Interventions: Other: Long-term Follow-Up

• Registration Number: NCT06116110
• Lead Sponsor: Miltenyi Biomedicine GmbH

Brief 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.

Study Timeline

• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-03
• Study Start: 2024-05-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2039-12-01
• Study Completion: 2039-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Long-term Follow-Up	Long-term Follow-Up	No intervention

Primary Outcome Measures

Name	Time	Method
The incidence of serious and non serious adverse events of special interest	Up to 15 years	AESIs will be collected

Secondary Outcome Measures

Name	Time	Method
Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry)	Up to 15 years	Peripheral blood samples may be collected for RCL assessment
Objective response rate	Up to 15 years	ORR
Duration of zamtocabtagene autoleucel persistence	Up to 5 years	Peripheral blood samples will be collected to test for CAR T cells
Overall Survival	Up to 15 years	OS

Trial Locations

Locations (5)

Stanford University; 🇺🇸 Stanford, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Froedtert Hospital and the Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States