Prophylactic use of Tocilizumab to prevent complications after CAR-T therapy
Prospective Comparison Between Prophylactic and On-demand Use of Tocilizumab in CAR-T Recipients - a Randomized, Two Arm, Open-label, Single-center Trial
This study is testing if giving Tocilizumab before or during CAR-T therapy can help prevent serious side effects like cytokine release syndrome and neurotoxicity in patients with B-cell cancers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | Tocilizumab, CAR-T, immunotherapy |
| Locations | 1 site (Bern, Canton of Bern) |
| Trial ID | NCT06430736 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled to receive CAR-T treatment for lymphomas, leukemias, or myeloma.
Not a fit: Patients who have received Tocilizumab within the last three months or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of severe complications following CAR-T therapy, improving patient outcomes.
How similar studies have performed: While the use of Tocilizumab in this context is being explored, similar studies have shown promise in managing CRS, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bern, Canton of Bern
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.