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A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
Phase 1, PHASE2 trial testing EQ001 in Acute-graft-versus-host Disease in 30 participants. Completed in 21 November 2022.
| Lead sponsor | Equillium |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 15 July 2019 |
| Primary completion | 21 November 2022 |
| Estimated completion | 21 November 2022 |
| Sites | 16 locations across United States |
Equillium — full company profile →
12 and older, any sex, with Acute-graft-versus-host Disease or aGVHD. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
| Group | Value | 95% CI |
|---|---|---|
| EQ001 Dose Escalation (Part A) 0.4mg/kg | 4 | |
| EQ001 Dose Escalation (Part A) 0.8mg/kg | 17 | |
| EQ001 Dose Escalation (Part A) 1.6mg/kg | 9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| EQ001 Dose Escalation (Part A) 0.4mg/kg | 2 | |
| EQ001 Dose Escalation (Part A) 0.8mg/kg | 10 | |
| EQ001 Dose Escalation (Part A) 1.6mg/kg | 5 |
CD6 receptor expression levels - percent of baseline
| Group | Value | 95% CI |
|---|---|---|
| EQ001 Dose Escalation (Part A) 0.4mg/kg | 81.0 | ± 17.78 |
| EQ001 Dose Escalation (Part A) 0.8mg/kg | 23.7 | ± 15.76 |
| Eq001 Dose Escalation (Part A) 1.6mg/kg | 33.0 | ± 19.25 |
Time frame: Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | EQ001 Dose Escalation (Par… | EQ001 Dose Escalation (Par… | EQ001 Dose Escalation (Par… |
|---|---|---|---|---|
| Sepsis | Infections and infestations | — | — | — |
| Adenovirus infection | Infections and infestations | — | — | — |
| Graft versus host disease | Immune system disorders | — | — | — |
| Cardiac arrest | Cardiac disorders | — | — | — |
| Arthritis bacterial | Infections and infestations | — | — | — |
| COVID-19 | Infections and infestations | — | — | — |
| COVID-19 pneumonia | Infections and infestations | — | — | — |
| Klebsiella sepsis | Infections and infestations | — | — | — |
| Nocardiosis | Infections and infestations | — | — | — |
| pulmonary mucormycosis | Infections and infestations | — | — | — |
| Pulmonary sepsis | Infections and infestations | — | — | — |
| Skin infection | Infections and infestations | — | — | — |
| Staphylococcal sepsis | Infections and infestations | — | — | — |
| Graft versus host disease in gastrointestinal tract | Immune system disorders | — | — | — |
| Acute graft versus host disease | Immune system disorders | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — |
| Atrial flutter | Cardiac disorders | — | — | — |
| Pulseless electrical activity | Cardiac disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Intestinal infarction | Gastrointestinal disorders | — | — | — |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | — | — | — |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Physical deconditioning | General disorders | — | — | — |
| Reaction | System | EQ001 Dose Escalation (Par… | EQ001 Dose Escalation (Par… | EQ001 Dose Escalation (Par… |
|---|---|---|---|---|
| Oedema peripheral | General disorders | — | — | — |
| Platelet count decreased | Investigations | — | — | — |
| Fatigue | General disorders | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Blood alkaline phosphate increased | Investigations | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Skin ulcer | Skin and subcutaneous tissue disorders | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — |
| Hypophosphataemia | Metabolism and nutrition disorders | — | — | — |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Sinus tachycardia | Cardiac disorders | — | — | — |
| Graft versus host disease | Immune system disorders | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — |
| Hypotension | Vascular disorders | — | — | — |
| Generalised oedema | General disorders | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — | — | — |
| Hypermagnesaemia | Metabolism and nutrition disorders | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — |
| Hypercalcaemia | Metabolism and nutrition disorders | — | — | — |
| Vitamin D deficiency | Metabolism and nutrition disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Blood creatinine increased | Investigations | — | — | — |
| International normalised ratio increased | Investigations | — | — | — |
Most-reported serious reactions: Sepsis, Adenovirus infection, Graft versus host disease, Cardiac arrest, Arthritis bacterial, COVID-19, COVID-19 pneumonia, Klebsiella sepsis.
Data from ClinicalTrials.gov NCT03763318 adverse events section.
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03763318.
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