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 range18 Years

SexALL

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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

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

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