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Can CAR-T Therapy's Long-Term safety be tracked in the real world?

NCT ID NCT07777120

Knowledge-focused Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study looks at the long-term safety and effectiveness of lisocabtagene maraleucel (Liso-Cel), a CAR-T cell therapy, in adults with relapsed or refractory marginal zone lymphoma who have already tried at least two prior treatments. Instead of giving the therapy, researchers will analyze data already collected in a transplant registry during routine care. The goal is to see how well Liso-Cel works over time and to identify any serious side effects, such as severe immune reactions or secondary cancers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lisocabtagene maraleucel (Liso-Cel), a CAR-T cell therapy
What this could lead to
If successful, this study could provide real-world evidence on the long-term safety and effectiveness of Liso-Cel for marginal zone lymphoma, potentially supporting its continued use and informing treatment decisions.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results depend on registry data quality and may not reflect all patients. Long-term risks, such as secondary cancers or severe side effects, remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2048

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of adult participants with relapsed or refractory marginal zone lymphoma (R/R MZL) who have received at least 2 prior lines of systemic therapy, who are treated with at least 1 infusion of lisocabtagene maraleucel in the postmarketing setting, who are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants who meet the following eligibility criteria will be selected from the registry: * Participants of 18 years of age or older at the time of infusion * Participants with a diagnosis of relapsed or refractory marginal zone lymphoma (R/R MZL) * Participants have received at least two prior lines of systemic therapy * Participants have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel: * used for the treatment of R/R MZL, * within the FDA-approved indication and dosage per the United States prescribing information and * product specifications approved for commercial release in the USA. * Participants have consented to share their data with the registry and the Sponsor. Exclusion Criteria: Participants who meet the following exclusion criterion will not be eligible for selection from the registry: • Participants known to be participating in investigational studies at the time of lisocabtagene maraleucel infusion.

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Conditions

The condition(s) this trial relates to.

Lymphoma, B-Cell, Marginal Zone marginal zone lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Marginal zone lymphoma

Contacts and locations

Locations

  • Center for International Blood and Marrow Transplant Research (CIBMTR)

    Milwaukee, Wisconsin, 53226, United States

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