Safety and Clinical Activity of Itolizumab in aGVHD

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotech Pharmaceutical Co., Ltd.
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

• 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.