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).
Single group
RC1012 injection (allo-DNT cells)
Biological/VaccineRC1012 injection (allo-DNT cells) are from healthy donors and have been proved to be safe and demonstrated potent cytotoxicity against AML blasts from AML patients in preclinical and preliminary clinical studies. Allo- DNT cells will be collected from healthy donors (NO MHC match needed) and injected into patients. The drug for this study is an off-the-shelf product. Patients DO NOT need to wait for the cell manufacturing.
Dose-Limiting Toxicity (DLT)
To evaluate the safety, tolerability, and determine the recommended dosage of allo-DNT Cell Therapy for AML subjects after Allo-HSCT
Maximum Tolerated Dose (MTD)
MTD was the highest dose for DLT in ≤1/6 subjects
Incidence of abnormalities
Incidence of abnormalities in AE/SAE/laboratory tests/electrocardiograms/vital signs.
Pharmacokinetics (PK) indicator (Cmax)
The peak concentration of allo-DNT cells amplified in the peripheral blood (Cmax, detected by Flow Cytometry).
Pharmacokinetics (PK) indicator (AUC)
Allo-DNT cells blood concentrations will be measured at different time points to evaluate the area under the curve (AUC). (AUC, detected by Flow Cytometry).
Pharmacokinetics (PK) indicator (Tmax)
Allo-DNT cells blood concentrations will be measured at different time points to evaluate the peak time (Tmax) in peripheral blood. Tmax is defined as the time to reach the highest concentration (Tmax, detected by Flow Cytometry).
Pharmacokinetics (PK) indicator (T1/2)
Allo-DNT cells blood concentrations will be measured at different time points to evaluate the elimination half-life in hours (T1/2). T1/2 is defined as the time point when the concentration of allo-DNT reaches half of maximum in a patient's peripheral blood (T1/2, detected by Flow Cytometry).
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Guangdong Ruishun Biotech Co., Ltd
Lead sponsor
Anhui Provincial Hospital
Collaborator
