Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06116110

Enrollment

150

Registered

2023-11-03

Start date

2024-05-15

Completion date

2041-12-01

Last updated

2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Lymphoma, High Grade B-cell Lymphoma, Non Hodgkin Lymphoma, Primary Mediastinal B-cell Lymphoma (PMBCL), Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B Cell Lymphoma

Keywords

Chimeric antigen receptor, CAR T, CD19, CD20

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.

Interventions

OTHERLong-term Follow-Up

No intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up. * Provided written informed consent to participate in this study.

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Number of subjects with new or recurrence of pre-existing malignancy	Up to 15 years	—
Number of subjects with new incidence or exacerbation of a pre-existing neurological disorder	Up to 15 years	—
Number of subjects with new incidence or exacerbation of pre-existing rheumatologic or other autoimmune disorders	Up to 15 years	—
Number of subjects with new incidence of Grade ≥ 3 hematologic disorders	Up to 15 years	—
Number of subjects with related AEs, related SAEs, and all AESIs	Up to 15 years	AESIs will be collected

Secondary

Measure	Time frame	Description
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
Duration of zamtocabtagene autoleucel persistence	Up to 15 years	Peripheral blood samples will be collected to test for CAR T cells
Objective Response Rate (ORR)	Up to 15 years	ORR for subjects who did not have progressive disease at their last assessment in the parent study; will be assessed by IRC and Investigator using Lugano 2014 Criteria for DLBCL and SCNSL and using IPCG Criteria (Abrey 2005) for PCNSL
Overall Survival	Up to 15 years	OS, measured from the date of zamtocabtagene autoleucel infusion to the date of the subject's death or the date the subject is last to known to be alive
To determine the number of subjects who relapse after zamtocabtagene autoleucel infusion during LTFU	Up to 15 years	Disease relapse: Number of subjects who enter the study as responders and relapse
To assess immune reconstitution based on the recovery of total lymphocytes	Up to 15 years	Change from baseline in peripheral B cell and lymphocyte levels

Countries

United States

Contacts

CONTACTSadie Swift

clinicaltrials@miltenyi.com617-218-0044

CONTACTParis Jamiel