A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma

July 30, 2025 updated by: Institute of Hematology & Blood Diseases Hospital, China

A Prospective, Single-Arm, Single-Center, Phase II Clinical Trial of Siltuximab for Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity After CAR-T Treatment in Multiple Myeloma

This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Be informed and voluntarily sign the Informed Consent Form (ICF).
  2. Age ≥18 years old.
  3. Diagnosed with multiple myeloma according to IMWG diagnostic criteria.
  4. Developed CRS (grade ≥1) and/or ICANS (grade ≥1) after CAR-T treatment.

Exclusion Criteria:

  1. Creatinine clearance <30 mL/min.
  2. Platelet count <75,000/μL, absolute neutrophil count <1,000/μL, or hemoglobin <60 g/L at screening.
  3. ALT or AST >3× ULN, or bilirubin >2× ULN.
  4. Known severe cardiac conditions, including NYHA class III/IV heart failure, uncontrolled angina, arrhythmia, or hypertension, myocardial infarction within 6 months, or other uncontrolled/severe cardiovascular diseases, including prior cerebrovascular events with residual deficits.
  5. Severe comorbidities, including active infections, known active HBV/HCV, HIV infection, uncontrolled diabetes, or serious conditions like chronic restrictive lung disease or cirrhosis.
  6. Known intolerance to Siltuximab.
  7. Known central nervous system (CNS) involement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Siltuximab
Multiple myeloma patients with persistent grade 1 CRS/ICANS for 12 hours or grade ≥2 CRS/ICANS after CAR-T therapy will receive Siltuximab (11 mg/kg) immediately. If symptoms persist for another 12 hours, repeat Siltuximab and corticosteroids are allowed. If unresolved or worsened, rescue therapy with tocilizumab, corticosteroids, or other medications will be given.
Drug: Siltuximab
Siltuximab 11mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete CRS resolution rate
Time Frame: 14 days
14-day Complete CRS Resolution Rate: No CRS Symptoms for 24 Consecutive Hours
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CANS Resolution Rate
Time Frame: 28 day
28-day ICANS Resolution Rate
28 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 10, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

July 30, 2025

First Submitted That Met QC Criteria

July 30, 2025

First Posted (Actual)

August 6, 2025

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2025006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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