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Acute-graft-versus-host DiseasePhase 1/2EQUATENCT03763318

A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD

A Phase 1/2 study testing EQ001 in people with Acute-graft-versus-host Disease and aGVHD, run by Biocon Limited at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Acute-graft-versus-host Disease, aGVHD, GVHD
What is being tested?
EQ001
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
16 sitesUnited States
Study dates
15 Jul 2019to 21 Nov 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female subject at least 18 years of age for Part A, and at least 12 years of age for Part B.
  • Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or non myeloablative conditioning regimens.
  • Have a clinical diagnosis of acute GVHD requiring systemic immune suppressive therapy.
  • Deemed by the investigator to be likely to comply with the planned procedure as required by the protocol for the duration of the study

Who cannot join

  • Presence of morphologic relapsed primary malignancy, treatment for relapse after alloHSCT was performed, or requirement for rapid immunosuppressive treatment withdrawal for early malignancy relapse.
  • Evidence of graft failure based on cytopenia(s), and as determined by the investigator.
  • Evidence of post-transplant lymphoproliferative disease.
  • Any prior therapy for acute GVHD, except for alloHSCT prophylaxis regimens or systemically administered corticosteroids.
  • As determined by the investigator, any medical, psychiatric, or other condition or circumstance that is likely to negatively affect: the subject's participation in this clinical study, the subject's safety, or the reliability of the study data.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • University of Michigan - C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of North Carolina Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • University of Florida Health Shands Hospital

    Gainesville, Florida, 32610

  • University of Miami - Miller School of Medicine

    Miami, Florida, 33136

  • TriStar Centennial Medical Center (SCRI)

    Nashville, Tennessee, 53719

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Intermountain Healthcare

    Salt Lake City, Utah, 84103

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-4433

  • Washington University and Barnes Jewish Heart & Vascular Center

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of EQ001 in Subjects With Newly Diagnosed Acute Graft Versus Host Disease

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).

Read the detailed description

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.

Being tested
EQ001, EQ001 Placebo
Medical subject headings
Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EQ001Biological

    Also called Bmab600, Itolizumab

    Itolizumab [Bmab 600])

  • EQ001 PlaceboBiological

    EQ001 Placebo

Study groups in NCT03763318
Study groupRoleWhat they receive
EQ001 Dose Escalation (Part A)ExperimentalOpen label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.
Receives: Biological: EQ001
EQ001 (Part B)ExperimentalEQ001 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.
Receives: Biological: EQ001
EQ001 Placebo (Part B)Placebo comparatorPlacebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.
Receives: Biological: EQ001 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Study Day 85

  2. 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.

    Measured: Study Day 29

Secondary outcomes (9)

  1. Time to Maximum EQ001serum Concentration, Tmax

    Time to maximum EQ001 serum concentration, Tmax

    Measured: Day 337

  2. Maximum EQ001 Serum Drug Concentration, Cmax

    Maximum EQ001 serum drug concentration, Cmax

    Measured: Study Day 337

  3. Minimum EQ001 Serum Drug Concentration, Cmin

    Minimum EQ001 serum drug concentration prior to next dose, Cmin

    Measured: Study Day 337

  4. Total EQ001 Exposure Across Time, AUC (From Zero to Infinity)

    Total EQ001 exposure across time, AUC (from zero to infinity)

    Measured: Study Day 337

  5. Half Life of EQ001, t1/2

    Half life of EQ001, t1/2

    Measured: Study Day 337

  6. Volume of Distribution of EQ001, Vd

    Volume of distribution of EQ001, Vd

    Measured: Study Day 337

  7. Clearance, Cl

    Clearance, Cl

    Measured: Study Day 337

  8. 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

    Measured: Study Day 337

  9. CD6 Receptor Expression Levels

    CD6 receptor expression levels - percent of baseline

    Measured: Study Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2018
  2. Study start15 Jul 2019
  3. Primary completion21 Nov 2022
  4. Study completion21 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Part A is an open label 3+3 dose escalation Part B is blinded and randomized 2:1
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03763318
Sponsor's protocol ID
EQ001-aGVHD-001
Acronym
EQUATE
Status last verified
May 2026
First submitted
19 Nov 2018
Last updated
11 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35484649

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EQ001 in people with Acute-graft-versus-host Disease and aGVHD, run by Biocon Limited at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Treatment Emergent Adverse Events (time frame: Study Day 85). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03763318, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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