Prophylactic use of Tocilizumab to prevent complications after CAR-T therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of administering Tocilizumab prophylactically to patients receiving CAR-T cell therapy for B-cell malignancies such as myeloma, lymphoma, and leukemia. The study aims to determine if this approach can reduce the incidence and severity of cytokine release syndrome (CRS) and neurotoxicity (ICANS) associated with CAR-T treatment. Conducted at the Inselspital in Bern, Switzerland, the trial will enroll patients who are clinically fit for CAR-T therapy and have provided informed consent. Participants will receive Tocilizumab either before the CAR-T infusion or at the onset of CRS symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients planned to receive commercial CAR-T treatment for all registered indications comprising lymphomas, leukemias or myeloma at a single academic center (Bern Inselspital)
* With written informed consent
* Considered by the investigator to be clinically fit for this treatment
* Patients aged ≥18 years

Exclusion Criteria:

* Previous Tocilizumab treatment within 3 months prior to CAR-T infusion
* Patients with treatment with an investigational compound within 8 weeks prior to CAR-T infusion
* Women who are pregnant or breast feeding, or women intending to become pregnant during the study period; or participants lacking safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases during study treatment and for a total of 12 months; Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons

Where it's running

• Insel Gruppe AG
  Bern, Canton of Bern, Switzerland Recruiting

Study contacts

• Study coordinator: Thomas Pabst, Prof.
• Email: thomas.pabst@insel.ch
• Phone: +41 31 632 84 30

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.