Table 3.
Current Clinical Trials For Prevention Or Treatment Of CRS
| Trial Number | Study | Status | Inclusion Criteria | Intervention |
|---|---|---|---|---|
| NCT02906371 | A Two Cohort Pilot Study of Tocilizumab Optimization Timing for CAR-T19-Associated CRS Management in Pediatric Patients With CD19 Expressing Relapsed/Refractory B-cell ALL | Active, not recruiting Two cohorts, open-label, phase1/2 study |
Pediatric patients aged 1–24 years with CD19 expressing relapsed/refractory B-cell ALL | Two cohorts defined based upon pre-infusion high versus low tumor burden: 1. High tumor burden cohort (high risk of severe CRS) to receive earlier administration of tocilizumab for CRS 2. Low tumor burden cohort (low risk of severe CRS) to receive standard timing of tocilizumab for CRS |
| NCT04048434 | Effectivity of Extracorporeal Cytokine Adsorption (Cytosorb) as Additive Treatment of CAR-T Cell-Associated Cytokine Release (CRS) Syndrome and Encephalopathy Syndrome (CRES) | Not yet recruiting | Patients aged 18 or older who develop severe CRS (>3)/severe CRES (>3) and CRS/CRES onset <6 hrs. | Patients with severe CAR-T cell-associated CRS (defined as vasopressor dependent) will be treated with standard of care + cytokine adsorption (6 hourly for 24 hrs.). |
| NCT03696784 | A Phase I Study of Autologous Activated T-cells Targeting the CD19 Antigen and Containing Inducible Caspase 9 Safety Switch (iC9-CAR19) in Subjects With Relapsed/Refractory B-cell Lymphoma | Recruiting Phase I |
Patients aged 18 or older with relapsed or refractory B-cell Lymphoma | Patients who develop grade 4 CRS or grade ≥3 CRS or who develop grade ≥3 CRES or grade 2 CRES that is unresponsive to standard of care interventions will be given Rimiducid at 0.4 mg/kg. |
| NCT03016377 | Administration of Autologous CAR-T Cells Targeting the CD19 Antigen and Containing the Inducible Caspase9 Safety Switch in Patients With (iC9-CAR19) Relapsed/Refractory ALL | Recruiting Phase I | Patients aged 3–70 years with relapsed or refractory B-cell ALL | Patients who develop grade 4 CRS or grade 2/3 CRS that is unresponsive to standard of care interventions will be given Rimiducid at 0.4 mg/kg. |
| NCT04071366 | A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy | Study to open in January 2020 Phase 2 |
Patients 12 years and older eligible to receive either tisagenlecleucel or axicabtagene ciloleucel for approved hematologic indications | Oral administration of itacitinib 200 mg once daily for 30 days for the prevention of CRS |
Note: Source: from ClinicalTrials.Gov (accessed on October 1, 2019).