CompletedPhase 1

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

United States16 participantsStarted 2021-01-21

Plain-language summary

This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells

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: * All patients who received at least one CLBR001 cell dose and have either discontinued early or completed the core treatment protocol or any protocol such as a managed access protocol as applicable. * Subject is willing and able to adhere to the study visit schedule and other protocol requirements. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol Exclusion Criteria: * There are no specific exclusion criteria for this study

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

Incidence and duration of new adverse events, late onset adverse events, and events of special interest

Timeframe: 15 years

Incidence and duration of new serious adverse events

Timeframe: 15 years

Incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001

Timeframe: 15 years

Incidence of new malignancies

Timeframe: 15 years

Trial details

NCT IDNCT04488354

SponsorCalibr, a division of Scripps Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-06

View on ClinicalTrials.gov More Relapsed/Refractory B-cell Lymphomas 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

Incidence and duration of new adverse events, late onset adverse events, and events of special interest

Timeframe: 15 years

Incidence and duration of new serious adverse events

Timeframe: 15 years

Incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001

Timeframe: 15 years

Incidence of new malignancies

Timeframe: 15 years