RecruitingNot Applicable

Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy

Switzerland80 participantsStarted 2023-11-14

Plain-language summary

The goal of this observational study is to learn about vaccine immunity in patients with B-cell malignancies treated by chimeric antigen receptor T-cell therapies (CAR-T). The main questions it aims to answer are: * Do CAR-T cell therapy recipients lose vaccine protection against common vaccine-preventable pathogens * Are current re-vaccination recommendations sufficient in restoring vaccine-protection * Is this restored vaccine-protection after CAR-T cell therapy lost faster than usual * Do clinical or immunological factors predict vaccine response after CAR-T cell therapy

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: * Patient ≥ 18 years old * Suffering from a B-cell malignancy (B-cell acute lymphoblastic leukemia (ALL), B-cell non-hodgkin lymphoma (NHL), Follicular lymphoma (FL), Mantle Cell Lymphoma (MCL), Multiple myeloma (MM)) * Planned for a CAR-T cell therapy * Provided written informed consent Exclusion Criteria: * Previous or already started CAR-T cell therapy * \< 18 years old * Lack of consent

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

CAR-T cell therapy associated change in antibody levels against 5 vaccine preventable pathogens

Timeframe: 6 months after CAR-T cell therapy

Trial details

NCT IDNCT06333275

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12

Contact for this trial

Lukas N Baumann, MD

+41 31 664 3069 lukas.baumann2@insel.ch

View on ClinicalTrials.gov More Vaccine Immunity in CAR-T Cell Therapy Recipients trials