Trial · NCT03763318
A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
NCT03763318, Phase 1, Phase 2, Completed, Biocon Limited; results first posted 2025-04-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD. Trials, record NCT03763318. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03763318
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
- NCT number
- NCT03763318
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Biocon Limited
- Conditions
- Acute-graft-versus-host Disease, aGVHD, GVHD, GVHD, Acute
- Interventions
- EQ001, EQ001 Placebo
- First posted
- 2018-12-04
- Last updated
- 2026-06-11
- Results first posted
- 2025-04-18
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment Emergent Adverse Events | Study Day 85 | Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
| Primary | Overall Response Rate | Study Day 29 | 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. |
| Secondary | Time to Maximum EQ001serum Concentration, Tmax | Day 337 | Time to maximum EQ001 serum concentration, Tmax |
| Secondary | Maximum EQ001 Serum Drug Concentration, Cmax | Study Day 337 | Maximum EQ001 serum drug concentration, Cmax |
| Secondary | Minimum EQ001 Serum Drug Concentration, Cmin | Study Day 337 | Minimum EQ001 serum drug concentration prior to next dose, Cmin |
| Secondary | Total EQ001 Exposure Across Time, AUC (From Zero to Infinity) | Study Day 337 | Total EQ001 exposure across time, AUC (from zero to infinity) |
| Secondary | Half Life of EQ001, t1/2 | Study Day 337 | Half life of EQ001, t1/2 |
| Secondary | Volume of Distribution of EQ001, Vd | Study Day 337 | Volume of distribution of EQ001, Vd |
| Secondary | Clearance, Cl | Study Day 337 | Clearance, Cl |
| Secondary | Inflammatory Markers | Study Day 337 | 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment Emergent Adverse Events | Study Day 85 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Overall Response Rate | Study Day 29 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Maximum EQ001serum Concentration, Tmax | Day 337 | |||
| SECONDARY | Maximum EQ001 Serum Drug Concentration, Cmax | Study Day 337 | |||
| SECONDARY | Minimum EQ001 Serum Drug Concentration, Cmin | Study Day 337 | |||
| SECONDARY | Total EQ001 Exposure Across Time, AUC (From Zero to Infinity) | Study Day 337 | |||
| SECONDARY | Half Life of EQ001, t1/2 | Study Day 337 | |||
| SECONDARY | Volume of Distribution of EQ001, Vd | Study Day 337 | |||
| SECONDARY | Clearance, Cl | Study Day 337 | |||
| SECONDARY | Inflammatory Markers | Study Day 337 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment Emergent Adverse Events | EQ001 Dose Escalation (Part A) 0.4mg/kg | 4 | Participants | ||
| Number of Treatment Emergent Adverse Events | EQ001 Dose Escalation (Part A) 0.8mg/kg | 17 | Participants | ||
| Number of Treatment Emergent Adverse Events | EQ001 Dose Escalation (Part A) 1.6mg/kg | 9 | Participants | ||
| Overall Response Rate | EQ001 Dose Escalation (Part A) 0.4mg/kg | 2 | Participants | ||
| Overall Response Rate | EQ001 Dose Escalation (Part A) 0.8mg/kg | 10 | Participants | ||
| Overall Response Rate | EQ001 Dose Escalation (Part A) 1.6mg/kg | 5 | Participants | ||
| CD6 Receptor Expression Levels | EQ001 Dose Escalation (Part A) 0.4mg/kg | 81.0 | Standard Deviation 17.78 | Percent of baseline | |
| CD6 Receptor Expression Levels | EQ001 Dose Escalation (Part A) 0.8mg/kg | 23.7 | Standard Deviation 15.76 | Percent of baseline | |
| CD6 Receptor Expression Levels | Eq001 Dose Escalation (Part A) 1.6mg/kg | 33.0 | Standard Deviation 19.25 | Percent of baseline |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EQ001 Dose Escalation (Part A) 0.4mg/kg | 4 | |
| Overall Study | STARTED | EQ001 Dose Escalation (Part A) 0.8mg/kg | 17 | |
| Overall Study | STARTED | EQ001 Dose Escalation (Part A) 1.6mg/kg | 9 | |
| Overall Study | COMPLETED | EQ001 Dose Escalation (Part A) 0.4mg/kg | 3 | |
| Overall Study | COMPLETED | EQ001 Dose Escalation (Part A) 0.8mg/kg | 7 | |
| Overall Study | COMPLETED | EQ001 Dose Escalation (Part A) 1.6mg/kg | 3 | |
| Overall Study | NOT COMPLETED | EQ001 Dose Escalation (Part A) 0.4mg/kg | 1 | |
| Overall Study | NOT COMPLETED | EQ001 Dose Escalation (Part A) 0.8mg/kg | 10 | |
| Overall Study | NOT COMPLETED | EQ001 Dose Escalation (Part A) 1.6mg/kg | 6 |
Source ClinicalTrials.gov
Adverse events774
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oedema peripheral | General disorders | EQ001 Dose Escalation (Part A) 0.4mg/kg | 2 | 4 | 2 |
| other | Oedema peripheral | General disorders | EQ001 Dose Escalation (Part A) 0.8mg/kg | 9 | 17 | 9 |
| other | Oedema peripheral | General disorders | EQ001 Dose Escalation (Part A) 1.6mg/kg | 6 | 9 | 6 |
| other | Fatigue | General disorders | EQ001 Dose Escalation (Part A) 0.4mg/kg | 1 | 4 | 1 |
| other | Fatigue | General disorders | EQ001 Dose Escalation (Part A) 0.8mg/kg | 6 | 17 | 6 |
| other | Fatigue | General disorders | EQ001 Dose Escalation (Part A) 1.6mg/kg | 3 | 9 | 3 |
| other | Chills | General disorders | EQ001 Dose Escalation (Part A) 0.4mg/kg | 1 | 4 | 1 |
| other | Chills | General disorders | EQ001 Dose Escalation (Part A) 0.8mg/kg | 1 | 17 | 1 |
| other | Chills | General disorders | EQ001 Dose Escalation (Part A) 1.6mg/kg | 1 | 9 | 1 |
| other | Generalised oedema | General disorders | EQ001 Dose Escalation (Part A) 0.4mg/kg | 0 | 4 | 0 |
1 to 10 of 774Source ClinicalTrials.gov
See all 774 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EQ001 Dose Escalation (Part A) 0.4mg/kg | 1 | 4 |
| Total, all-cause mortality | EQ001 Dose Escalation (Part A) 0.8mg/kg | 7 | 17 |
| Total, all-cause mortality | EQ001 Dose Escalation (Part A) 1.6mg/kg | 6 | 9 |
| Total, other adverse events | EQ001 Dose Escalation (Part A) 0.4mg/kg | 4 | 4 |
| Total, other adverse events | EQ001 Dose Escalation (Part A) 0.8mg/kg | 17 | 17 |
| Total, other adverse events | EQ001 Dose Escalation (Part A) 1.6mg/kg | 9 | 9 |
| Total, serious adverse events | EQ001 Dose Escalation (Part A) 0.4mg/kg | 2 | 4 |
| Total, serious adverse events | EQ001 Dose Escalation (Part A) 0.8mg/kg | 9 | 17 |
| Total, serious adverse events | EQ001 Dose Escalation (Part A) 1.6mg/kg | 8 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35484649 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03763318
GET https://conductscience.org/api/trials/v1/NCT03763318/events?page=2