Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
ConditionNon Hodgkin Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMiltenyi Biomedicine GmbH
About this trial
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Patients who have received MB-CART2019.1
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Long-term Follow-Up
Other interventionNo intervention
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Long-term Follow-Up1 intervention
Trial outcomes
Primary outcomes
1
The incidence of serious and non serious adverse events of special interest
AESIs will be collected
Time frame
Up to 15 yearsSecondary outcomes
1
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
Time frame
Up to 15 years2
Duration of zamtocabtagene autoleucel persistence
Peripheral blood samples will be collected to test for CAR T cells
Time frame
Up to 5 years3
Objective response rate
ORR
Time frame
Up to 15 years4
Overall Survival
OS
Time frame
Up to 15 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov