NCT05426798

Clinical Study of TQB2618 Injection in Combination With Demethylation Drugs in Patients With Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes

Phase I Clinical Study of TQB2618 Injection in Combination With Demethylation Drugs in Patients With Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	TQB2618 injection azacitidine, AZA decitabine, DAC	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.

Timeline

• Start date: 2022-04-29
• Primary completion: 2023-09-01
• Completion: 2023-12-01
• First posted: 2022-06-22
• Last updated: 2022-06-22

Locations

1 site across 1 country: China