Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT04443751
Eligibility Criteria:
Inclusion Criteria:
1. Male or female.
2. ≥18 years of age.
3. Refractory/Relapsed AML, or failed to achieve complete remission after 2 cycles of induction therapy.
4. 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).
5. Life expectancy≥12 months.
6. With Adequate hematologic and organ function
7. Signed inform consent form
Exclusion Criteria:
1. With a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
2. With significant cardiovascular disease.
3. With a history of autoimmune disease.
4. 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.
5. Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or hepatitis C.
6. Active or untreated central nervous system (CNS) metastases.
7. Active infection within 2 weeks.
8. Know to be allergic to the ingredients of SHR-1702 injection.
9. Prior allogeneic bone marrow transplantation or solid organ transplant
10. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04443751
Study Brief:
Protocol Section:
NCT04443751