CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled / 24 target
Drug / intervention
Siltuximabdrug
Likely dose
Siltuximab 11mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04975555
NCT04975555Phase 2CompletedUpdate Overdue (0.4/mo)Completion was 5mo ago
CompareCT.gov

A Phase II Pilot Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to Chimeric Antigen Receptor T-Cell Therapy (CAR-T) in Hematological Malignancies

University of Alabama at Birmingham·interventional·Posted Jul 23, 2021·Updated Jun 3, 2026

In Brief

A Phase 2 clinical trial evaluating Siltuximab for Cytokine Release Syndrome and 4 related conditions. Completed, enrolled 24 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This study will evaluate the use of siltuximab to decrease the severity of cytokine release syndrome (CRS) and immune effector cell-associated neurological syndrome (ICANS) in patients who will receive chimeric antigen receptor (CAR) T-cell therapy for the treatment of hematological malignancies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytokine Release Syndrome, ICANS, Lymphoma, Non-Hodgkin, Multiple Myeloma, Acute Lymphoblastic Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJul 23, 2021
Enrollment StartNov 15, 2021
Primary CompletionJan 20, 2026
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 4.9 years ago

Arms & Interventions

Siltuximabexperimental

Patients who experience CRS/ICANS will receive this treatment

Drug: Siltuximab

Interventions

Siltuximabdrug

Siltuximab is administered at the dose of 11mg/kg via intravenous infusion over 1 hour. If no resolution of CRS is achieved then a repeat dose of siltuximab at the dose of 11mg/kg via intravenous infusion over 1 hour will be given.