Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

Non Hodgkin Lymphoma Clinical Trial

Official title:

A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06116110
• Other study ID #: M-2023-401
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: December 1, 2039

Study information

• Verified date: April 2024
• Source: Miltenyi Biomedicine GmbH
• Contact: Paris Jamiel
• Phone: 617-218-0044
• Email: clinicaltrials[@]miltenyi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 1, 2039
• Est. primary completion date: December 1, 2039
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Intervention

Other:
• Long-term Follow-Up
No intervention

Locations

Country	Name	City	State
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	Yale University	New Haven	Connecticut
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Miltenyi Biomedicine GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of serious and non serious adverse events of special interest	AESIs will be collected	Up to 15 years
Secondary	Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry)	Peripheral blood samples may be collected for RCL assessment	Up to 15 years
Secondary	Duration of zamtocabtagene autoleucel persistence	Peripheral blood samples will be collected to test for CAR T cells	Up to 5 years
Secondary	Objective response rate	ORR	Up to 15 years
Secondary	Overall Survival	OS	Up to 15 years