This study is designed for exploring the preliminary safety and efficacy of the recombinant allogeneic healthy γδT cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell hematolymphatic malignancies.
A single arm open-label clinical study is designed to prelinarily determine the safety, efficacy, the ratio of CD19-positive cells in peripheral blood and cell kinetics after administration of UTAA09 injection in patients with CD19-positive relapsed/refractory B-cell hematolymphatic malignancies. All subjects will receive UTAA09 cells infusion. Primary objective: explore the preliminary safety and efficacy of UTAA09 injection in patients with CD19-positive relapsed/refractory B-cell line hematolymphatic malignancies. Secondary objectives: 1. explore the distribution, amplification and survival of UTAA09 cells in vivo after administration of UTAA09 injection; 2. explore the ratio of CD19-positive cells in peripheral blood after administration of UTAA09 injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Intravenous injection, dosage:1-10×10\^8 CAR+ γδT cells, Cell concentration: 2×10\^7 cells/mL.
30 mg/m\^2/day×4 days
1000 mg/m\^2/day×3 days
The First Affiliated Hospital of USTC (AnHui Provincial Hospital)
Hefei, Anhui, China
RECRUITINGAssessment of the safety after UTAA09 injection treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: About 2 years
Evaluation of the efficacy after UTAA09 injection treatment
3-month total response rate (ORR) which includes CR, CRi, and PR will be assessed.
Time frame: About 3 months
Assessment of pharmacokinetic (about Cmax)
Assessment of the peak Plasma Concentration (Cmax) of UTAA09 cells amplified in peripheral blood after administration.
Time frame: About 2 years
Assessment of pharmacokinetic (about Tmax)
Assessment of the time to reach the highest concentration (Tmax) of UTAA09 cells amplified in peripheral blood after administration.
Time frame: About 2 years
Assessment of pharmacokinetic (about AUC0-28d)
Assessment of the Area under the plasma concentration versus time curve (AUC) for 28 days after UTAA09 cells administration.
Time frame: About 2 years
Assessment of pharmacokinetic (about AUC0-90d)
Assessment of the Area under the plasma concentration versus time curve (AUC) for 90 days after UTAA09 cells administration.
Time frame: About 2 years
Evaluation of Pharmacodynamic
To determine the depletion of peripheral blood CD19-positive B cells at each time point, the concentration of CAR-γδT-associated serum cytokine (CRP, IL-6, etc.).
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Time frame: About 2 years
To evaluate the efficacy (Overall Survival)
Defined as the time from the start of UTAA09 injection therapy to patient death (due to any cause).
Time frame: About 2 years
To evaluate the efficacy (Duration Of Response)
Defined as the time from the first tumor assessment of CR or PR, CR or CRi to the first assessment of disease recurrence or progression or death (due to any cause).
Time frame: About 2 years
To evaluate the efficacy (Progression Free Survival)
Defined as the time from the start of UTAA09 injection therapy to the first disease progression or recurrence or death due to any cause.
Time frame: About 2 years