A Study to Evaluate the Safety, Tolerability, PK, PD, and... | NCT03763318

Label	Type	Description	Intervention Names
EQ001 Dose Escalation (Part A)	Experimental	Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.	Biological: EQ001
EQ001 (Part B)	Experimental	EQ001 administered in a blinded fashion using the optimal dose selected from Part A by intravenous infusion every two weeks for a total of 5 doses.	Biological: EQ001
EQ001 Placebo (Part B)	Placebo Comparator	Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.	Biological: EQ001 Placebo

Name	Type	Description	Arm Group Labels	Other Names
EQ001	Biological	Itolizumab [Bmab 600])	EQ001 (Part B) EQ001 Dose Escalation (Part A)

Measure	Description	Time Frame
Number of Treatment Emergent Adverse Events	Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.	Study Day 85
Overall Response Rate	Overall Response Rate (ORR) is defined as the number of subjects with a partial response (PR), very good partial response (VGPR), or complete response (CR) who are alive at Day 29. Subjects must not have received new systemic therapy for aGVHD before the Day 29 Visit.	Study Day 29

Measure	Description	Time Frame
Time to Maximum EQ001serum Concentration, Tmax	Time to maximum EQ001 serum concentration, Tmax	Day 337
Maximum EQ001 Serum Drug Concentration, Cmax	Maximum EQ001 serum drug concentration, Cmax

Name	Affiliation	Role
Joel Rothman	Equillium	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope Comprehensive Cancer Center		Duarte	California	91010	United States
University of Florida Health Shands Hospital

PubMed Identifier	Type	Citation	Retractions
35484649	Derived	Rambaldi B, Kim HT, Arihara Y, Asano T, Reynolds C, Manter M, Halpern M, Weber A, Koreth J, Cutler C, Gooptu M, Nikiforow S, Ho VT, Antin JH, Romee R, Ampudia J, Ng C, Connelly S, Soiffer RJ, Ritz J. Phenotypic and functional characterization of the CD6-ALCAM T-cell co-stimulatory pathway after allogeneic cell transplantation. Haematologica. 2022 Nov 1;107(11):2617-2629. doi: 10.3324/haematol.2021.280444.

Label	URL
Company website	View source

ID	Title	Description
FG000	EQ001 Dose Escalation (Part A) 0.4mg/kg	Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.4mg/kg EQ001: Itolizumab [Bmab 600]
FG001	EQ001 Dose Escalation (Part A) 0.8mg/kg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 24, 2021	Mar 10, 2025

ID	Title	Description
BG000	EQ001 Dose Escalation (Part A) 0.4mg/kg	Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.4mg/kg EQ001: Itolizumab [Bmab 600]
BG001	EQ001 Dose Escalation (Part A) 0.8mg/kg	Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.8mg/kg EQ001: Itolizumab [Bmab 600]
BG002	EQ001 Dose Escalation (Part A) 1.6mg/kg	Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 1.6mg/kg EQ001: Itolizumab [Bmab 600]
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0004 BG00117 BG0029 BG00330

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Oedema peripheral	General disorders	Non-systematic Assessment	EG0002 events2 affected4 at risk EG0019 events9 affected17 at risk EG0026 events6 affected9 at risk
Fatigue	General disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0016 events6 affected17 at risk EG0023 events3 affected9 at risk
Chills	General disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Generalised oedema	General disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0021 events1 affected9 at risk
Asthenia	General disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Pyrexia	General disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0013 events3 affected17 at risk EG0025 events5 affected9 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0013 events3 affected17 at risk EG0024 events4 affected9 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0016 events6 affected17 at risk EG0020 events0 affected9 at risk
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected17 at risk EG0022 events2 affected9 at risk
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0022 events2 affected9 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0014 events4 affected17 at risk EG0020 events0 affected9 at risk
Hypophosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0013 events3 affected17 at risk EG0021 events1 affected9 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0021 events1 affected9 at risk
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0022 events2 affected9 at risk
Hypercalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0020 events0 affected9 at risk
Hypernatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Hyperuricaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0022 events2 affected9 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected4 at risk EG0014 events4 affected17 at risk EG0023 events3 affected9 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0012 events2 affected17 at risk EG0020 events0 affected9 at risk
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0021 events1 affected9 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0013 events3 affected17 at risk EG0020 events0 affected9 at risk
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0020 events0 affected9 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Stomatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Platelet count decreased	Investigations	Systematic Assessment	EG0001 events1 affected4 at risk EG0019 events9 affected17 at risk EG0023 events3 affected9 at risk
Blood alkaline phosphate increased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0014 events4 affected17 at risk EG0022 events2 affected9 at risk
Neutrophil count decreased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0014 events4 affected17 at risk EG0022 events2 affected9 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0014 events4 affected17 at risk EG0021 events1 affected9 at risk
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0023 events3 affected9 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0022 events2 affected9 at risk
Blood bilirubin increased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0013 events3 affected17 at risk EG0021 events1 affected9 at risk
Blood creatinine increased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0022 events2 affected9 at risk
Gamma-glutamyltransferase increased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0013 events3 affected17 at risk EG0020 events0 affected9 at risk
International normalised ratio increased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0021 events1 affected9 at risk
White blood cell count decreased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0021 events1 affected9 at risk
Blood lactic acid increased	Investigations	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0020 events0 affected9 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0023 events3 affected9 at risk
Bacteraemia	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0020 events0 affected9 at risk
Cytomegalovirus infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0020 events0 affected9 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0022 events2 affected9 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0022 events2 affected9 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0021 events1 affected9 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0020 events0 affected9 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0022 events2 affected9 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0014 events4 affected17 at risk EG0020 events0 affected9 at risk
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0020 events0 affected9 at risk
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0015 events5 affected17 at risk EG0024 events4 affected9 at risk
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0020 events0 affected9 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected4 at risk EG0014 events4 affected17 at risk EG0020 events0 affected9 at risk
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0022 events2 affected9 at risk
Infusion related reaction	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected4 at risk EG0013 events3 affected17 at risk EG0020 events0 affected9 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0013 events3 affected17 at risk EG0021 events1 affected9 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0022 events2 affected9 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0021 events1 affected9 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0022 events2 affected9 at risk
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0013 events3 affected17 at risk EG0021 events1 affected9 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0021 events1 affected9 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0020 events0 affected9 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0015 events5 affected17 at risk EG0021 events1 affected9 at risk
Agitation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0022 events2 affected9 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0021 events1 affected9 at risk
Confusional state	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0020 events0 affected9 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Graft versus host disease	Immune system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0013 events3 affected17 at risk EG0020 events0 affected9 at risk
Graft versus host disease in gastrointestinal tract	Immune system disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Hypogammaglobulinaemia	Immune system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0021 events1 affected9 at risk
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0013 events3 affected17 at risk EG0023 events3 affected9 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0022 events2 affected9 at risk
Dysuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Hypertension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0022 events2 affected9 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0013 events3 affected17 at risk EG0021 events1 affected9 at risk
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0020 events0 affected9 at risk
Vision blurred	Eye disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected17 at risk EG0021 events1 affected9 at risk
Adrenal insufficiency	Endocrine disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Cholecystitis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0021 events1 affected9 at risk
Chest discomfort	General disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Chest Pain	General disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Influenza like illness	General disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected17 at risk EG0020 events0 affected9 at risk
Localised oedema	General disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Mucosal dryness	General disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected17 at risk EG0020 events0 affected9 at risk
Physical deconditioning	General disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Gout	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Hyperferritinaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected17 at risk EG0020 events0 affected9 at risk
Hypocalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Lactose intolerance	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Metabolic acidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Vitamin B complex deficiency	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Abdominal pain lower	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Anal fissure	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Ascites	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Haemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Ileus	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Intestinal infarction	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Blood albumin decreased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Blood lactate dehydrogenase increased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Blood urea increased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Corona virus test positive	Investigations	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected17 at risk EG0020 events0 affected9 at risk
Ejection fraction decreased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Electrocardiogram QT prolonged	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Haptoglobin decreased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Liver function test increased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Oxygen saturation decreased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Transaminases increased	Investigations	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Adenovirus infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Arthritis bacterial	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
BK virus infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
COVID-19	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
COVID-19 pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Candida infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Clostridium difficile colitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected17 at risk EG0020 events0 affected9 at risk
Clostridium difficile infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Cytomegalovirus infection reactivation	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Cytomegalovirus viraemia	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Endocarditis	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Enterococcal bacteraemia	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Epstein-Barr virus infection reactivation	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Influenza	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Klebsiella sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Nocardiosis	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Oral candidiasis	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Parainfluenzae virus infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected17 at risk EG0020 events0 affected9 at risk
Pharyngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Pulmonary mucormycosis	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Pulmonary sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Sialoadenitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Skin infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected17 at risk EG0020 events0 affected9 at risk
Staphylococcal sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Pleuritic Pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected17 at risk EG0020 events0 affected9 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Eczema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Leukoplakia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Onychomadesis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected17 at risk EG0020 events0 affected9 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Skin weeping	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Leukopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Skin abrasion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Vascular access complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Wound dehiscence	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Myopathy	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected17 at risk EG0020 events0 affected9 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Bradycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected17 at risk EG0020 events0 affected9 at risk
Pericardial effusion	Cardiac disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Pulseless electrical activity	Cardiac disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Delirium	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Intensive care unit delirium	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Irritability	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Substance-induced psychotic disorder	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Cognitive disorder	Nervous system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Dizziness postural	Nervous system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Dysgeusia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Embolic stroke	Nervous system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Lethargy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Acute graft versus host disease	Immune system disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Hydronephrosis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Angiopathy	Vascular disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Embolism	Vascular disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Eye irritation	Eye disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Lacrimation increased	Eye disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Scleral haemorrhage	Eye disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Hepatic cirrhosis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Hepatitis fulminant	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Ear congestion	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Tinnitus	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Azoospermia	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Breast pain	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Scrotal oedema	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected17 at risk EG0020 events0 affected9 at risk
Dental implantation	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected17 at risk EG0021 events1 affected9 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	EQ001 Dose Escalation (Part A) 0.4mg/kg	Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.4mg/kg. EQ001: Itolizumab [Bmab 600]	1	4	2	4	4	4
EG001	EQ001 Dose Escalation (Part A) 0.8mg/kg	Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.8mg/kg. EQ001: Itolizumab [Bmab 600]	7	17	9	17	17	17
EG002	EQ001 Dose Escalation (Part A) 1.6mg/kg	Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 1.6mg/kg. EQ001: Itolizumab [Bmab 600]	6	9	8	9	9	9