This project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. The purpose is to evaluate the tolerability and initially evaluate the antitumor efficacy of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Drug1: TQB2618 injection is a novel tim-3 inhibitor. Drug2: Azacitidine (5-azacytidine) is a cytidine nucleoside analogue that selectively inhibits DeoxyriboNucleic Acid methyltransferases at low doses, resulting in gene promoter hypomethylation. Drug3: Decitabine is a cytidine deoxy nucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGMaximum tolerated dose (MTD)
To evaluate MTD of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Time frame: Baseline up to 78 weeks
Dose limited toxicity (DLT)
To evaluate DLT of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Time frame: Baseline up to 78 weeks
Recommended Phase II Dose (RP2D)
To evaluate RP2D of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Time frame: Baseline up to 78 weeks
Objective Response Rate
To evaluate ORR of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Time frame: Baseline up to 78 weeks
Adverse events (AE)
incidence and severity of adverse events (AE)
Time frame: Baseline up to 92 weeks
Receptor occupation (RO)
Receptor occupation (RO) of Tim-3 after administration
Time frame: Baseline up to 92 weeks
anti-drug antibody (ADA)/ neutralizing antibody (Nab)
Immunogenicity related indicators: the incidence and titer of the subjects' anti-drug antibody (ADA) and the incidence of neutralizing antibody (Nab);
Time frame: Baseline up to 92 weeks
Progress Free Survival (PFS) Progress Free Survival (PFS)
Time from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first
Time frame: up to 92weeks
Disease control rate (DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 92weeks
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Time frame: up to 92weeks
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