Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

• Sponsor: Miltenyi Biomedicine GmbH (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06116110
• Collaborator: (none)
• Enrollment: 150
• Locations: 5
• Anticipated Duration (Months): 192.4
• Patients Per Site: 30
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non Hodgkin Lymphoma	Other: Long-term Follow-Up

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 Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Anticipated Study Start Date: Nov 20, 2023
• Anticipated Primary Completion Date: Dec 1, 2039
• Anticipated Study Completion Date: Dec 1, 2039

Arms and Interventions

Arm	Intervention/Treatment
Long-term Follow-Up No intervention	Other: Long-term Follow-Up; No intervention

Outcome Measures

Primary Outcome Measures

1. The incidence of serious and non serious adverse events of special interest [Up to 15 years]

   AESIs will be collected

Secondary Outcome Measures

1. 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

2. Duration of zamtocabtagene autoleucel persistence [Up to 5 years]

   Peripheral blood samples will be collected to test for CAR T cells

3. Objective response rate [Up to 15 years]

   ORR

4. Overall Survival [Up to 15 years]

   OS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305
2	Yale University	New Haven	Connecticut	United States	06520
3	University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center	Baltimore	Maryland	United States	21201
4	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
5	Froedtert Hospital and the Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Miltenyi Biomedicine GmbH

Investigators

• Study Director: Remi Kaleta, MD, Miltenyi Biomedicine GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Miltenyi Biomedicine GmbH
• ClinicalTrials.gov Identifier: NCT06116110
• Other Study ID Numbers: M-2023-401
• First Posted: Nov 3, 2023
• Last Update Posted: Nov 3, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Miltenyi Biomedicine GmbH: Chimeric antigen receptor; CAR T; CD19; CD20
• Additional relevant MeSH terms: Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of Nov 3, 2023