Safety and Clinical Activity of Itolizumab in aGVHD

NCT05823675 | Unknown Phase 1

• 1 other identifier: BPL-ITO-aGVHD-1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Graft Versus Host Disease

Outcome Measures

Primary Outcomes (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

  Study Day 85

Secondary Outcomes (15)

• Time to maximum Itolizumab serum concentration, Tmax

  Study Day 85

• Maximum Itolizumab serum drug concentration, Cmax

  Study Day 85

• Minimum Itolizumab serum drug concentration, Cmin

  Study Day 85

• Total Itolizumab exposure across time, AUC

  Study Day 85

• Half life of Itolizumab, t1/2

  Study Day 85

Study Arms (4)

Itolizumab Dose Level 1

EXPERIMENTAL

Itolizumab of 25 mg administered by intravenous infusion every 2 weeks for a total of 5 doses.

Drug: Itolizumab; Drug: Methylprednisolone

Itolizumab Dose Level 2

EXPERIMENTAL

Itolizumab of 50 mg administered by intravenous infusion every 2 weeks for a total of 5 doses.

Drug: Itolizumab; Drug: Methylprednisolone

Itolizumab Dose Level 3

EXPERIMENTAL

Itolizumab of 100 mg administered by intravenous infusion every 2 weeks for a total of 5 doses.

Drug: Itolizumab; Drug: Methylprednisolone

Itolizumab Dose Level 4

EXPERIMENTAL

Itolizumab of 150 mg administered by intravenous infusion every 2 weeks for a total of 5 doses.

Drug: Itolizumab; Drug: Methylprednisolone

Interventions

Itolizumab DRUG

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

Also known as: T1h

Itolizumab Dose Level 1; Itolizumab Dose Level 2; Itolizumab Dose Level 3; Itolizumab Dose Level 4

Methylprednisolone DRUG

Methylprednisolone will be taperred as required

Also known as: Methylprednisolone Sodium Succinate

Itolizumab Dose Level 1; Itolizumab Dose Level 2; Itolizumab Dose Level 3; Itolizumab Dose Level 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (1)

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

Tianjin, 300020, China

RECRUITING

MeSH Terms

Interventions

itolizumab; Methylprednisolone; Methylprednisolone Hemisuccinate

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Erlie Jiang

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xijuan Song

CONTACT

010-51571020; songxijuan@biotechplc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 21, 2023
• Study Start: May 19, 2023
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: May 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)