CRS - Cytokine Release SyndromePhase 2NCT07106671
A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma
A Phase 2 study testing Siltuximab in people with CRS - Cytokine Release Syndrome and Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRS - Cytokine Release Syndrome, Myeloma
- What is being tested?
- Siltuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2025to 1 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin
Gang An, 86-022-23909171, angang@ihcams.ac.cn
About this study
Official title: 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.
- Conditions
- CRS - Cytokine Release Syndrome, Myeloma
- Being tested
- Siltuximab
- Medical subject headings
- Cytokine Release Syndrome, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiltuximabDrug
Siltuximab 11mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Siltuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete CRS resolution rate
14-day Complete CRS Resolution Rate: No CRS Symptoms for 24 Consecutive Hours
Measured: 14 days
Secondary outcomes (1)
CANS Resolution Rate
28-day ICANS Resolution Rate
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start10 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRS - Cytokine Release SyndromeStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106671
- Sponsor's protocol ID
- IIT2025006
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07106671
- Acronym / sponsor ID
- IIT2025006
- Conditions
- CRS - Cytokine Release Syndrome, Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Siltuximab | Experimental | Drug: SiltuximabMultiple 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SiltuximabSiltuximab 11mg/kg | Drug | Siltuximab |
Primary outcome
Complete CRS resolution rate
Time frame: 14 days
14-day Complete CRS Resolution Rate: No CRS Symptoms for 24 Consecutive Hours
1 secondary outcome
CANS Resolution Rate
Time frame: 28 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Siltuximab in people with CRS - Cytokine Release Syndrome and Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang An, PhD&MD (86-022-23909171, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete CRS resolution rate (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.