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Long-Term Follow-Up for Zamtocabtagene Autoleucel in Non-Hodgkin Lymphoma

This study is observing people who previously received a gene therapy called zamtocabtagene autoleucel (also known as MB-CART2019.1) for Non-Hodgkin Lymphoma. It's a long-term follow-up to see how you're doing after treatment. The study will track any side effects (adverse events) you might experience for up to 15 years. It also looks at how well the treatment continues to work and how long the CAR-T cells (a type of immune cell modified by the gene therapy) stay in your body. You can join if you're 18 or older, have previously received zamtocabtagene autoleucel in a Miltenyi Biomedicine study, and agree to participate. The study aims to enroll 150 people, but its current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without providing new treatment. It plans to include 150 participants.
What's involved
You will be monitored yearly for up to 15 years for side effects, replication competent lentivirus, and the long-term effectiveness of the treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 15 years after receiving zamtocabtagene autoleucel.

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NCT06116110

Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

Recruiting
Not specifiedAges 18+Observational
Miltenyi Biomedicine GmbH
~150 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Long-term Follow-Up

At a glance

Recruiting sites
10 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of subjects with new or recurrence of pre-existing malignancy
Measured over Up to 15 years
+4 more outcomes measured

Conditions

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

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Non-Hodgkin Lymphoma

Where it's being run

11 sites across 11 states
Arizona1
California1
Connecticut1
Illinois1
Kansas1
Maryland1
Massachusetts1
North Carolina1

Study leadership

  • Remi Kaleta, MD · STUDY_DIRECTOR · Miltenyi Biomedicine GmbH

Who to contact

Sadie Swift
[email protected]
617-218-0044
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

None

What this trial measures

  • Number of subjects with new or recurrence of pre-existing malignancyUp to 15 years
  • Number of subjects with new incidence or exacerbation of a pre-existing neurological disorderUp to 15 years
  • Number of subjects with new incidence or exacerbation of pre-existing rheumatologic or other autoimmune disordersUp to 15 years
  • Number of subjects with new incidence of Grade ≥ 3 hematologic disordersUp to 15 years
  • Number of subjects with related AEs, related SAEs, and all AESIsUp to 15 years

    AESIs will be collected