A Phase 1/2 interventional study of EQ001 and EQ001 Placebo in Acute-graft-versus-host Disease, aGVHD and GVHD, sponsored by Biocon Limited. Completed at 16 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Biocon Limited · Phase 1/2, Interventional, and Treatment
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).
The study will enroll approximately 100 subjects in two (2) parts:
Part A is an open label study and will enroll approximately 40 evaluable subjects with aGVHD across 4 cohorts. The total number of patients will depend on the number of dose escalations necessary to enable a decision to be made on the recommended dose to take forward into Part B of the study. The planned dose escalation will start with cohort 1, where subjects will receive EQ001 administered intravenously every two weeks for a total of 5 doses.
Part B is a randomized, double-blind, placebo-controlled study and will enroll approximately 60 additional subjects, randomized in a 2:1 ratio to either active treatment EQ001 (40) or placebo (20). Subjects will receive either EQ001 or placebo administered intravenously every two weeks for a total of 5 doses.
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 30 is below the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Biocon Limited is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.
Biological: EQ001
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
Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.
Biological: EQ001 Placebo
Itolizumab \[Bmab 600\])
Also known as: Bmab600, Itolizumab
EQ001 Placebo
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.
Time frame: 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.
Time frame: Study Day 29
Time to Maximum EQ001serum Concentration, Tmax
Time to maximum EQ001 serum concentration, Tmax
Time frame: Day 337
Maximum EQ001 Serum Drug Concentration, Cmax
Maximum EQ001 serum drug concentration, Cmax
Time frame: Study Day 337
Minimum EQ001 Serum Drug Concentration, Cmin
Minimum EQ001 serum drug concentration prior to next dose, Cmin
Time frame: Study Day 337
Total EQ001 Exposure Across Time, AUC (From Zero to Infinity)
Total EQ001 exposure across time, AUC (from zero to infinity)
Time frame: Study Day 337
Half Life of EQ001, t1/2
Half life of EQ001, t1/2
Time frame: Study Day 337
Volume of Distribution of EQ001, Vd
Volume of distribution of EQ001, Vd
Time frame: Study Day 337
Clearance, Cl
Clearance, Cl
Time frame: Study Day 337
Inflammatory Markers
Including but not limited to: IL-1β, IL-2, IL-6, IL-17, IL-21, IL-22, IL-23, IFN-γ, and TGF-β, C-reactive protein
Time frame: Study Day 337
CD6 Receptor Expression Levels
CD6 receptor expression levels - percent of baseline
Time frame: Study Day 85
| Milestone | EQ001 Dose Escalation (Part A) 0.4mg/kg | EQ001 Dose Escalation (Part A) 0.8mg/kg | EQ001 Dose Escalation (Part A) 1.6mg/kg |
|---|---|---|---|
| Started | 4 | 17 | 9 |
| Completed | 3 | 7 | 3 |
| Not completed | 1 | 10 | 6 |
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
| Participants | EQ001 Dose Escalation (Part A) 0.4mg/kg | EQ001 Dose Escalation (Part A) 0.8mg/kg | EQ001 Dose Escalation (Part A) 1.6mg/kg |
|---|---|---|---|
| Number of Treatment Emergent Adverse Events | 4 | 17 | 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.
| Participants | EQ001 Dose Escalation (Part A) 0.4mg/kg | EQ001 Dose Escalation (Part A) 0.8mg/kg | EQ001 Dose Escalation (Part A) 1.6mg/kg |
|---|---|---|---|
| Overall Response Rate | 2 | 10 | 5 |
Time to maximum EQ001 serum concentration, Tmax
Results for this outcome have not been posted.
Maximum EQ001 serum drug concentration, Cmax
Results for this outcome have not been posted.
Minimum EQ001 serum drug concentration prior to next dose, Cmin
Results for this outcome have not been posted.
Total EQ001 exposure across time, AUC (from zero to infinity)
Results for this outcome have not been posted.
Half life of EQ001, t1/2
Results for this outcome have not been posted.
Volume of distribution of EQ001, Vd
Results for this outcome have not been posted.
Clearance, Cl
Results for this outcome have not been posted.
Including but not limited to: IL-1β, IL-2, IL-6, IL-17, IL-21, IL-22, IL-23, IFN-γ, and TGF-β, C-reactive protein
Results for this outcome have not been posted.
CD6 receptor expression levels - percent of baseline
| Percent of baseline | EQ001 Dose Escalation (Part A) 0.4mg/kg | EQ001 Dose Escalation (Part A) 0.8mg/kg | Eq001 Dose Escalation (Part A) 1.6mg/kg |
|---|---|---|---|
| CD6 Receptor Expression Levels | 81.0 ± 17.78 | 23.7 ± 15.76 | 33.0 ± 19.25 |
Collected over Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EQ001 Dose Escalation (Part A) 0.4mg/kg | 1/4 (25%) | 2/4 (50%) | 4/4 (100%) |
| EQ001 Dose Escalation (Part A) 0.8mg/kg | 7/17 (41.2%) | 9/17 (52.9%) | 17/17 (100%) |
| EQ001 Dose Escalation (Part A) 1.6mg/kg | 6/9 (66.7%) | 8/9 (88.9%) | 9/9 (100%) |
| Event | EQ001 Dose Escalation (Part A) 0.4mg/kg | EQ001 Dose Escalation (Part A) 0.8mg/kg | EQ001 Dose Escalation (Part A) 1.6mg/kg |
|---|---|---|---|
| Adenovirus infectionInfections and infestations | 0/4 | 0/17 | 8/9 |
| SepsisInfections and infestations | 0/4 | 9/17 | 2/9 |
| Skin infectionInfections and infestations | 1/4 | 0/17 | 0/9 |
| Graft versus host disease in gastrointestinal tractImmune system disorders | 1/4 | 0/17 | 1/9 |
| PyrexiaGeneral disorders | 1/4 | 0/17 | 0/9 |
| Graft versus host diseaseImmune system disorders | 0/4 | 3/17 | 0/9 |
| Cardiac arrestCardiac disorders | 0/4 | 2/17 | 0/9 |
| Arthritis bacterialInfections and infestations | 0/4 | 0/17 | 1/9 |
| Klebsiella sepsisInfections and infestations | 0/4 | 0/17 | 1/9 |
| NocardiosisInfections and infestations | 0/4 | 0/17 | 1/9 |
| Event | EQ001 Dose Escalation (Part A) 0.4mg/kg | EQ001 Dose Escalation (Part A) 0.8mg/kg | EQ001 Dose Escalation (Part A) 1.6mg/kg |
|---|---|---|---|
| Oedema peripheralGeneral disorders | 2/4 | 9/17 | 6/9 |
| HypokalaemiaMetabolism and nutrition disorders | 0/4 | 3/17 | 5/9 |
| Platelet count decreasedInvestigations | 1/4 | 9/17 | 3/9 |
| DiarrhoeaGastrointestinal disorders | 2/4 | 4/17 | 3/9 |
| HypomagnesaemiaMetabolism and nutrition disorders | 1/4 | 3/17 | 4/9 |
| AnaemiaBlood and lymphatic system disorders | 0/4 | 5/17 | 4/9 |
| FatigueGeneral disorders | 1/4 | 6/17 | 3/9 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/4 | 6/17 | 0/9 |
| Lymphocyte count decreasedInvestigations | 0/4 | 2/17 | 3/9 |
| Urinary tract infectionInfections and infestations | 0/4 | 1/17 | 3/9 |
| Age, Continuous(years) | EQ001 Dose Escalation (Part A) 0.4mg/kg | EQ001 Dose Escalation (Part A) 0.8mg/kg | EQ001 Dose Escalation (Part A) 1.6mg/kg | Total |
|---|---|---|---|---|
| Mean | 44.3 ± 18.03 | 60.1 ± 10.86 | 54.6 ± 12.98 | 56.3 ± 13.22 |
| Sex: Female, Male(Participants) | EQ001 Dose Escalation (Part A) 0.4mg/kg | EQ001 Dose Escalation (Part A) 0.8mg/kg | EQ001 Dose Escalation (Part A) 1.6mg/kg | Total |
|---|---|---|---|---|
| Female | 0 | 6 | 4 | 10 |
| Male | 4 | 11 | 5 | 20 |
| Race (NIH/OMB)(Participants) | EQ001 Dose Escalation (Part A) 0.4mg/kg | EQ001 Dose Escalation (Part A) 0.8mg/kg | EQ001 Dose Escalation (Part A) 1.6mg/kg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 3 | 0 | 3 |
| White | 4 | 14 | 8 | 26 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
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Biocon Limited