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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2618 injection | Experimental | TQB2618 injection combined with demethylation drugs, 28 days as a treatment cycle until the disease progresses or the investigator judges that it is not suitable for subject to continue to take medicine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2618 injection azacitidine, AZA decitabine, DAC | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | To evaluate MTD of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes. | 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. | 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. | 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. | Baseline up to 78 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE) | incidence and severity of adverse events (AE) | Baseline up to 92 weeks |
| Receptor occupation (RO) | Receptor occupation (RO) of Tim-3 after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Wu, Doctor | Contact | 18980601973 | wuyulily@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
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|
| 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); | 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 | up to 92weeks |
| Disease control rate (DCR) | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 92weeks |
| Duration of Response (DOR) | The time when the participants first achieved complete or partial remission to disease progression. | up to 92weeks |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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