To evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT
Voluntarily sign an ICF and expect to complete the study procedures for follow-up examinations and treatment.
Aged 18 to 70 years (including cut-offs), regardless of gender.
Subject must be diagnosed with AML according to World Health Organization (WHO) criteria (2016).
The subject has received an allogeneic HSCT within 60-100 days, the percentage of malignant primitive cells in the bone marrow is < 5% after HSCT and STR-PCR shows complete donor chimerism.
Subject is confirmed to have morphological relapse of leukemia or positive MRD after allo-HSCT.
Subject with extramedullary infiltration of leukemia.
Suffer from other malignancies within 5 years prior to screening, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, post-radical thyroid cancer, and post-radical ductal carcinoma in situ.
Has severe respiratory disease (previous or combined history of severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm).
Guangdong Ruishun Biotech Co., Ltd
Lead sponsor
Anhui Provincial Hospital
Collaborator