Trial Outcomes & Findings for Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy (NCT NCT04975555)
NCT ID: NCT04975555
Last Updated: 2026-07-27
Results Overview
Participants who achieve a resolution of CRS. Resolution of CRS is defined as absence of symptoms leading to diagnosis of CRS for 24 hours.
COMPLETED
PHASE2
20 participants
Baseline through 14 days
2026-07-27
Participant Flow
Participant milestones
| Measure |
Siltuximab
Patients who experience CRS/ICANS will receive this treatment
Siltuximab: 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.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy
Baseline characteristics by cohort
| Measure |
Siltuximab
n=20 Participants
Patients who experience CRS/ICANS will receive this treatment
Siltuximab: 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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=9 Participants
|
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Age, Categorical
Between 18 and 65 years
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15 Participants
n=9 Participants
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Age, Categorical
>=65 years
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5 Participants
n=9 Participants
|
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Age, Continuous
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59 years
n=9 Participants
|
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Sex: Female, Male
Female
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6 Participants
n=9 Participants
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Sex: Female, Male
Male
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14 Participants
n=9 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=9 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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20 Participants
n=9 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=9 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=9 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Black or African American
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5 Participants
n=9 Participants
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Race (NIH/OMB)
White
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15 Participants
n=9 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
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Region of Enrollment
United States
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20 participants
n=9 Participants
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PRIMARY outcome
Timeframe: Baseline through 14 daysParticipants who achieve a resolution of CRS. Resolution of CRS is defined as absence of symptoms leading to diagnosis of CRS for 24 hours.
Outcome measures
| Measure |
Siltuximab
n=19 Participants
Patients who experience CRS/ICANS will receive this treatment
Siltuximab: 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.
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|---|---|
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Participants With a Complete Response for Cytokine Release Syndrome (CRS)
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15 Participants
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SECONDARY outcome
Timeframe: Baseline through 28 daysParticipants who achieve a resolution or improvement in their ICANS. Complete response or partial response for ICANS is defined as either complete disappearance or decrease in the grade of severity as measured by ASTCT Consensus Grading for ICANS. The ASTCT grade is from 1 to 5 for ICANS with 1 being mild symptoms and 5 being severe symptoms.
Outcome measures
| Measure |
Siltuximab
n=20 Participants
Patients who experience CRS/ICANS will receive this treatment
Siltuximab: 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.
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|---|---|
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Participants With a Response for Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS)
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11 Participants
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SECONDARY outcome
Timeframe: Baseline through 28 daysAll Adverse Events (AE's) will be reported and evaluated using National Cancer Institute's Common Terminology Criteria (CTCAE) v5.0.
Outcome measures
| Measure |
Siltuximab
n=20 Participants
Patients who experience CRS/ICANS will receive this treatment
Siltuximab: 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.
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|---|---|
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Participants Experiencing Adverse Events From Siltuximab
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0 Participants
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SECONDARY outcome
Timeframe: Baseline through day 90This will be measured by using specific criteria's for Lymphoma, Multiple Myeloma or Acute Lymphoblastic Leukemia (ALL) \[Based on the patients diagnosis\]
Outcome measures
| Measure |
Siltuximab
n=20 Participants
Patients who experience CRS/ICANS will receive this treatment
Siltuximab: 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.
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|---|---|
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Participants With Response to CAR T-cell Therapy
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20 Participants
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Adverse Events
Siltuximab
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place