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Acute Graft Versus Host DiseasePhase 1NCT05823675

Safety and Clinical Activity of Itolizumab in aGVHD

A Phase 1 study testing Itolizumab and Methylprednisolone in people with Acute Graft Versus Host Disease, run by Biotech Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the safety, tolerability, PK, PD, and clinical activity of Itolizumab in subjects with Newly diagnosed Acute Graft Versus Host Disease(aGVHD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Graft Versus Host Disease
What is being tested?
Itolizumab and Methylprednisolone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
19 May 2023to Feb 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subject at least 18 years of age.
  • Has received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
  • Clinical diagnosis of Grade II-IV aGVHD per MAGIC guideline requiring systemic immune suppressive therapy.
  • Initiation of systemic steroids therapy ≤ 72 hours.
  • Negative result of serum HCG within 72 hours before enrollment for female with potential fertility.
  • Have a life expectancy of 10 weeks or more.
  • Able to understand and comply with the planned procedure as required by the protocol, and sign a written informed consent form (ICF).

Who cannot join

  • Has received more than 1 allo-HSCT.
  • 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.
  • aGVHD induced by donor lymphocyte infusion(DLI).
Show all 23Show fewer
  • Clinically or suspected diagnosed of cGVHD or overlap syndrome.
  • Unresolved toxicity or complications due to allo-HSCT,other than aGVHD.
  • Any clinical or laboratory abnormalities that is likely to negatively affect the reliability of the study safety data, as determined by the investigator.
  • Presence of any uncontrolled active infections, which was defined as hemodynamic instability due to sepsis or worsening of new symptoms, signs, or imaging findings due to infection.
  • Presence of any uncontrolled and active infections.
  • Presence of active and uncontrolled viral infections at screening.
  • History of active tuberculosis within 6 months prior to screening or negative result of interferon-gamma release assay at screening.
  • History of class III or IV congestive heart failure per New York Heart Association, clinically significant or uncontrolled unstable angina or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 6 months prior to screening.
  • Severe impaired renal function at screening (serum creatinine > 1.5 ULN or creatinine clearance < 30mL/min).
  • Presence of persistent bilirubin abnormalities induced by hepatic sinusoidal obstruction, hepatic veno-occlusive disease, non-GVHD or progressive organ dysfunction at screening.
  • Serum ALT and AST > 4 ULN at screening.
  • Absolute lymphocyte count < 0.5×109/L at screening.
  • Any major surgical procedures performed within 4 weeks prior to screening, that is likely to negatively affect the evaluation of the study safety data, as determined by the investigator.
  • Any malignant tumor other than the transplanted tumor within 5 years before screening.
  • Suspected allergic to the experimental drug product or any of its excipients.
  • Currently pregnant, breastfeeding,or planning to become pregnant or not using reliable method to avoid pregnancy during study and within 3 months after the last study treatment.
  • As determined by the investigator, any medical, psychiatric, or other condition or circumstance that is likely to negatively affect the reliability of the study data.

Trial locations and contacts

1 site in 1 country.

Xijuan Song contact

010-51571020

songxijuan@biotechplc.com

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    Tianjin, 300020

    Erlie Jiang

    Recruiting

Other trials in China

About this study

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

To evaluate the safety, tolerability, PK, PD, and clinical activity of Itolizumab in subjects with Newly diagnosed Acute Graft Versus Host Disease(aGVHD).

Read the detailed description

The study will enroll approximately 44 subjects in three parts:

Part 1 is an open label 3+3 single dose escalation phase and will enroll approximately 30 subjects with aGVHD across 4 cohorts, where subjects will receive Itolizumab administered intravenously for 1 dose.

Part 2 is an open label phase and subjects from part 1 will receive Itolizumab administered intravenously every two weeks for a total of 4 doses.

Part 3 is a randomized phase and will enroll approximately 14 additional subjects, randomized in a 1:1 ratio to one of the 2 recommended doses provided by Part 1 and Part 2. Subjects will receive Itolizumab administered intravenously every two weeks for a total of 5 doses.

Being tested
Itolizumab, Methylprednisolone

What participants receive

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

  • ItolizumabDrug

    Also called T1h

    Subjects will receive Itolizumab concomitant within 72 hours of systematic Corticosteroids.

  • MethylprednisoloneDrug

    Also called Methylprednisolone Sodium Succinate

    Methylprednisolone will be taperred as required

Study groups in NCT05823675
Study groupRoleWhat they receive
Itolizumab Dose Level 1ExperimentalItolizumab of 25 mg administered by intravenous infusion every 2 weeks for a total of 5 doses.
Receives: Drug: Itolizumab; Drug: Methylprednisolone
Itolizumab Dose Level 2ExperimentalItolizumab of 50 mg administered by intravenous infusion every 2 weeks for a total of 5 doses.
Receives: Drug: Itolizumab; Drug: Methylprednisolone
Itolizumab Dose Level 3ExperimentalItolizumab of 100 mg administered by intravenous infusion every 2 weeks for a total of 5 doses.
Receives: Drug: Itolizumab; Drug: Methylprednisolone
Itolizumab Dose Level 4ExperimentalItolizumab of 150 mg administered by intravenous infusion every 2 weeks for a total of 5 doses.
Receives: Drug: Itolizumab; Drug: Methylprednisolone

What is being measured

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

  1. Incidence of Treatment Emergent Adverse Events

    Number of subjects with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0

    Measured: Study Day 85

Secondary outcomes (15)

  1. Time to maximum Itolizumab serum concentration, Tmax

    Time to maximum Itolizumab serum concentration

    Measured: Study Day 85

  2. Maximum Itolizumab serum drug concentration, Cmax

    Maximum Itolizumab serum drug concentration

    Measured: Study Day 85

  3. Minimum Itolizumab serum drug concentration, Cmin

    Minimum Itolizumab serum drug concentration

    Measured: Study Day 85

  4. Total Itolizumab exposure across time, AUC

    Total Itolizumab exposure across time, AUC

    Measured: Study Day 85

  5. Half life of Itolizumab, t1/2

    Half life of Itolizumab

    Measured: Study Day 85

  6. Volume of distribution of Itolizumab, Vd

    Volume of distribution of Itolizumab

    Measured: Study Day 85

  7. Clearance, Cl

    Clearance

    Measured: Study Day 85

  8. CD6 receptor expression levels on T cells

    CD6 receptor expression levels

    Measured: Study Day 85

  9. T cell subsets

    T cell subsets

    Measured: Study Day 85

  10. Inflammatory Markers

    Including but not limited to:IL-2, IL-6, IL-8, IL-17, IFN-γ, TNF-α, CRP, TNFR1, ST2, REG3α, Elafin

    Measured: Study Day 85

  11. Overall Response Rate (ORR)

    Percentage of subjects demonstrating a CR or PR.

    Measured: Study Day 337

  12. Nonrelapse Mortality(NRM) Rate

    Proportion of subjects who died due to causes other than malignancy relapse

    Measured: Study Day 337

  13. cGVHD rate

    Percentage of subjects demonstrating of cGVHD

    Measured: Study Day 337

  14. Dose Reduction in Systemic Steroid Use

    Change from Baselinein Dose of Systemic Steroid Use

    Measured: Study Day 337

  15. Incidence of ADA

    Precentage of subjects presenting anti-drug antibody

    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 posted21 Apr 2023
  2. Study start19 May 2023
  3. Primary completionOct 2024 (estimated)
  4. Study completionFeb 2025 (estimated)

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05823675
Sponsor's protocol ID
BPL-ITO-aGVHD-1
Status last verified
Apr 2023
First submitted
16 Mar 2023
Last updated
25 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Itolizumab and Methylprednisolone in people with Acute Graft Versus Host Disease, run by Biotech Pharmaceutical Co., Ltd. at 1 site in China.

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 7 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Xijuan Song (010-51571020, songxijuan@biotechplc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Emergent Adverse Events (time frame: Study Day 85). 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 NCT05823675.

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 25 May 2023.

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