Status:
COMPLETED
A Safety and Efficacy Study of SHR-1702 Monotherapy in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
AML
MDS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will assess the safety and preliminary efficacy of escalating doses of SHR-1702 monotherapy in relapsed/refractory AML and intermediate-high risk MDS
Eligibility Criteria
Inclusion
- Male or female.
- ≥18 years of age.
- Refractory/Relapsed AML, or failed to achieve complete remission after 2 cycles of induction therapy.
- Intermediate, High and very high risk MDS according to the revised International Prognostic Scoring System (IPSS-R) who have failed prior therapies, such as azacitidine and decitabine (Scoring≥3.5).
- Life expectancy≥12 months.
- With Adequate hematologic and organ function
- Signed inform consent form
Exclusion
- With a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- With significant cardiovascular disease.
- With a history of autoimmune disease.
- Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
- Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or hepatitis C.
- Active or untreated central nervous system (CNS) metastases.
- Active infection within 2 weeks.
- Know to be allergic to the ingredients of SHR-1702 injection.
- Prior allogeneic bone marrow transplantation or solid organ transplant
- With a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Key Trial Info
Start Date :
September 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04443751
Start Date
September 10 2020
End Date
February 28 2023
Last Update
August 24 2023
Active Locations (1)
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1
Blood disease hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300041