Trial Outcomes & Findings for Anakinra for the Prevention of Cytokine Release Syndrome and Neurotoxicity in Patients With B-Cell Non-Hodgkin Lymphoma Receiving CD19-Targeted CAR-T Cell Therapy (NCT NCT04359784)

Last Updated: 2025-10-23

Results Overview

Will assess the efficacy of anakinra in preventing the occurrence of any grade CRS using the Bayesian optimal phase 2 design. Assessed based on the ASTCT Consensus Grading for CRS and Neurotoxicity Associated with Immune Effector Cell.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Up to 28 days after lisocabtagene maraleucel (liso-cel) infusion

Results posted on

2025-10-23

Participant Flow

Of 27 enrolled participants, 25 met inclusion criteria and started treatment.

Participant milestones

Participant milestones
Measure	Prevention (anakinra, lisocabtagene maraleucel) Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
Overall Study STARTED	25
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Prevention (anakinra, lisocabtagene maraleucel) Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
Overall Study Death	2

Baseline Characteristics

Anakinra for the Prevention of Cytokine Release Syndrome and Neurotoxicity in Patients With B-Cell Non-Hodgkin Lymphoma Receiving CD19-Targeted CAR-T Cell Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prevention (anakinra, lisocabtagene maraleucel) n=27 Participants Patients receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Patients should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Patients also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
Age, Continuous Age Known	69 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 28 days after lisocabtagene maraleucel (liso-cel) infusion

Population: Not applicable here (no difference between number of participants analyzed

Outcome measures

Outcome measures
Measure	Prevention (anakinra, lisocabtagene maraleucel) n=25 Participants Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
Absence of Any Grade Cytokine Release Syndrome (CRS) CRS	16 Participants
Absence of Any Grade Cytokine Release Syndrome (CRS) No CRS	9 Participants

SECONDARY outcome

Timeframe: Up to 28 days after liso-cel infusion

CRS severity was graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria (Lee et al, Biol Blood Marrow Transplant, 2019) based on the presence and severity of fever, hypotension, and hypoxia: grade 1, fever ≥38°C without hypotension or hypoxia; grade 2, hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; grade 3, hypotension requiring a single vasopressor or hypoxia requiring high-flow oxygen; grade 4, life-threatening hypotension requiring multiple vasopressors and/or hypoxia requiring positive-pressure ventilation; grade 5, death.

Outcome measures

Outcome measures
Measure	Prevention (anakinra, lisocabtagene maraleucel) n=25 Participants Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
CRS Grade Peak CRS Grade 3	1 Participants
CRS Grade Peak CRS Grade 0	9 Participants
CRS Grade Peak CRS Grade 1	8 Participants
CRS Grade Peak CRS Grade 2	7 Participants

SECONDARY outcome

Timeframe: Up to 28 days after liso-cel infusion

ICANS severity was graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria (Lee et al, Biol Blood Marrow Transplant, 2019): grade 1, immune effector cell-associated encephalopathy (ICE, overall score range 0-10, higher score = better condition) score 7-9, awakens spontaneously; grade 2, ICE score 3-6, awakens to voice; grade 3, ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on EEG that resolve with intervention, focal/local oedema on neuroimaging; grade 4, ICE 0, unarousable and unable to perform ICE, unarousable or requires vigorous or repetitive tactile stimuli to arouse, stupor or coma, life-threatening prolonged seizure (\>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, diffuse cerebral oedema on neuroimaging, decerebrate or decorticate posturing, or cranial nerve VI

Outcome measures

Outcome measures
Measure	Prevention (anakinra, lisocabtagene maraleucel) n=25 Participants Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
ICANS Grade Peak ICANS Grade 0	16 Participants
ICANS Grade Peak ICANS Grade 1	4 Participants
ICANS Grade Peak ICANS Grade 2	2 Participants
ICANS Grade Peak ICANS Grade 3	3 Participants

SECONDARY outcome

Timeframe: Up to 28 days after liso-cel infusion

Number of patients hospitalized after liso-cel treatment.

Outcome measures

Outcome measures
Measure	Prevention (anakinra, lisocabtagene maraleucel) n=25 Participants Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
Rate of Hospitalization After Liso-cel Treatment	18 Participants

SECONDARY outcome

Timeframe: Up to 28 days after liso-cel infusion

Population: The number of days in the hospital (hospitalized only) group only included patients who were hospitalized (n=18)

Duration of hospitalization measured in days following liso-cel administration.

Outcome measures

Outcome measures
Measure	Prevention (anakinra, lisocabtagene maraleucel) n=25 Participants Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
Duration of Hospitalization After Liso-cel Treatment Number of days in the hospital (all pts)	6 days Interval 0.0 to 10.0
Duration of Hospitalization After Liso-cel Treatment Number of days in the hospital (hospitalized only)	8 days Interval 5.0 to 20.0

SECONDARY outcome

Timeframe: Up to 28 days after liso-cel infusion

Number of patients who received corticosteroids within 28 days after liso-cel infusion.

Outcome measures

Outcome measures
Measure	Prevention (anakinra, lisocabtagene maraleucel) n=25 Participants Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
Corticosteroid Usage After Liso-cel Treatment	10 Participants

SECONDARY outcome

Timeframe: Approximately 90 days after liso-cel infusion

Population: Six patients were not evaluable for this endpoint due to lack of measurable disease prior to treatment.

Best response within approximately 90 days post liso-cel infusion will be assessed based on institutional standard using physical examination, imaging (CT or PET-CT), and if necessary, bone marrow biopsies, in patients with measurable disease prior to treatment.

Outcome measures

Outcome measures
Measure	Prevention (anakinra, lisocabtagene maraleucel) n=25 Participants Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
Disease Response to Liso-cel CR	8 Participants
Disease Response to Liso-cel PR	5 Participants
Disease Response to Liso-cel SD	2 Participants
Disease Response to Liso-cel PD	4 Participants
Disease Response to Liso-cel Not evaluable	6 Participants

SECONDARY outcome

Timeframe: Up to 28 days after liso-cel infusion

Grade 3 or greater AEs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Outcome measures

Outcome measures
Measure	Prevention (anakinra, lisocabtagene maraleucel) n=25 Participants Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
Adverse Events (AEs)	25 Participants

Adverse Events

Prevention (anakinra, lisocabtagene maraleucel)

Serious events: 15 serious events

Other events: 25 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Prevention (anakinra, lisocabtagene maraleucel) n=25 participants at risk Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
Immune system disorders Cytokine release syndrome	44.0% 11/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
General disorders Fever	16.0% 4/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Cardiac disorders Atrial fibrillation	8.0% 2/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
General disorders Chills	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Psychiatric disorders Confusion	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Vascular disorders Hypotension	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Nervous system disorders Other	12.0% 3/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.

Other adverse events

Other adverse events
Measure	Prevention (anakinra, lisocabtagene maraleucel) n=25 participants at risk Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection
Investigations Lymphocyte count increased	100.0% 25/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Investigations Neutrophil count decreased	88.0% 22/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Investigations White blood cell decreased	80.0% 20/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
General disorders Fever	48.0% 12/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Vascular disorders Hypotension	40.0% 10/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Immune system disorders Cytokine release syndrome	24.0% 6/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Nervous system disorders Other	24.0% 6/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Investigations Platelet count decreased	24.0% 6/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Psychiatric disorders Confusion	20.0% 5/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
General disorders Fatigue	20.0% 5/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Nervous system disorders Encephalopathy	16.0% 4/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Nervous system disorders Dysphasia	12.0% 3/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Respiratory, thoracic and mediastinal disorders Hypoxia	12.0% 3/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Nervous system disorders Headache	8.0% 2/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Gastrointestinal disorders Abdominal pain	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Psychiatric disorders Agitation	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Blood and lymphatic system disorders Anemia	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Metabolism and nutrition disorders Anorexia	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Respiratory, thoracic and mediastinal disorders Apnea	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Cardiac disorders Atrial fibrillation	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
General disorders Chills	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Psychiatric disorders Delirium	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Nervous system disorders Dizziness	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Nervous system disorders Dysgeusia	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
General disorders Edema limbs	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Blood and lymphatic system disorders Febrile neutropenia	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Investigations Fibrinogen decreased	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Psychiatric disorders Hallucinations	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Respiratory, thoracic and mediastinal disorders Hiccups	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Metabolism and nutrition disorders Hyperglycemia	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Vascular disorders Hypertension	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Cardiac disorders Sinus tachycardia	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Nervous system disorders Somnolence	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Nervous system disorders Tremor	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
Cardiac disorders Ventricular tachycardia	4.0% 1/25 • All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.

Additional Information

Jordan Gauthier

Fred Hutchinson Cancer Center

Phone: 206-667-2713

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place