To evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT
This study aims to evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT. DNT cells are mature T lymphocytes that comprise 3-10% of T cells in human peripheral blood mononuclear cells (PBMC). Allo-DNT cells from healthy donors 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 infused into patients. The drug for this study is an off-the-shelf product. Patients DO NOT need to wait for the cell manufacturing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
72
RC1012 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.
The First Hospital of the University of Science and Technology of China
Hefei, Anhui, China
RECRUITINGDose-Limiting Toxicity (DLT)
To evaluate the safety, tolerability, and determine the recommended dosage of allo-DNT Cell Therapy for AML subjects after Allo-HSCT
Time frame: Up to 28 days
Maximum Tolerated Dose (MTD)
MTD was the highest dose for DLT in ≤1/6 subjects
Time frame: Up to 28 days
Incidence of abnormalities
Incidence of abnormalities in AE/SAE/laboratory tests/electrocardiograms/vital signs.
Time frame: Up to 28 days
Pharmacokinetics (PK) indicator (Cmax)
The peak concentration of allo-DNT cells amplified in the peripheral blood (Cmax, detected by Flow Cytometry).
Time frame: Up to 2 years
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).
Time frame: Up to 2 years
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).
Time frame: Up to 2 years
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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Time frame: Up to 2 years
Recurrence rate at 6 months
Record the proportion of patients with recurrence in the study.
Time frame: Up to 6 months
Relapse-free survival (RFS)
Relapse-free survival is the time from study enrollment until documented disease relapse, or death from any cause.
Time frame: Up to 2 years
GvHD-free and relapse-free survival (GRFS)
GRFS is the time from study enrollment until documented disease relapse, or death, or GvHD occur from any cause.
Time frame: Up to 2 years
2-year overall survival
From the date of entry into the clinical study until death from any cause.
Time frame: Up to 2 years