RecruitingNot Applicable

Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

United States150 participantsStarted 2024-05-15

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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* Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up.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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of subjects with new or recurrence of pre-existing malignancy

Timeframe: Up to 15 years

Number of subjects with new incidence or exacerbation of a pre-existing neurological disorder

Timeframe: Up to 15 years

Number of subjects with new incidence or exacerbation of pre-existing rheumatologic or other autoimmune disorders

Timeframe: Up to 15 years

Number of subjects with new incidence of Grade ≥ 3 hematologic disorders

Timeframe: Up to 15 years

Number of subjects with related AEs, related SAEs, and all AESIs

Timeframe: Up to 15 years

Trial details

NCT IDNCT06116110

SponsorMiltenyi Biomedicine GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2041-12-01

Contact for this trial

Sadie Swift

617-218-0044 clinicaltrials@miltenyi.com

View on ClinicalTrials.gov More Non Hodgkin Lymphoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of subjects with new or recurrence of pre-existing malignancy

Timeframe: Up to 15 years

Number of subjects with new incidence or exacerbation of a pre-existing neurological disorder

Timeframe: Up to 15 years

Number of subjects with new incidence or exacerbation of pre-existing rheumatologic or other autoimmune disorders

Timeframe: Up to 15 years

Number of subjects with new incidence of Grade ≥ 3 hematologic disorders

Timeframe: Up to 15 years

Number of subjects with related AEs, related SAEs, and all AESIs

Timeframe: Up to 15 years