A Phase II Study of Siltuximab for CRS/ICANs After CAR-T... | NCT07106671

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

NCT07106671

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Status

Recruiting

Last Update Posted

Aug 6, 2025Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

CRS - Cytokine Release Syndrome
Myeloma

Interventions

Siltuximab

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2025Estimated

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 1, 2027Estimated

First Submitted Date

Jul 30, 2025

First Submission Date that Met QC Criteria

Jul 30, 2025

First Posted Date

Aug 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2025

Last Update Posted Date

Aug 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Siltuximab	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Siltuximab	Drug	Siltuximab 11mg/kg	Siltuximab

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Creatinine clearance <30 mL/min.
Platelet count <75,000/μL, absolute neutrophil count <1,000/μL, or hemoglobin <60 g/L at screening.
ALT or AST >3× ULN, or bilirubin >2× ULN.
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.
Severe comorbidities, including active infections, known active HBV/HCV, HIV infection, uncontrolled diabetes, or serious conditions like chronic restrictive lung disease or cirrhosis.
Known intolerance to Siltuximab.
Known central nervous system (CNS) involement.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gang An, PhD&MD	Contact	86-022-23909171		angang@ihcams.ac.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences	Recruiting	Tianjin			China

Condition Browse Module

MeSH Terms

ID	Term
D000080424	Cytokine Release Syndrome
D054219	Neoplasms, Plasma Cell

Ancestor Terms

ID	Term
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided