This study carried out a phase Ib clinical trial of TQB2928 injection combined therapy in patients with hematological malignancies, to explore the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of TQB2928 injection combined with azacitidine for injection in Acute Myeloid Leukemia (AML)/Myelodysplastic Syndromes (MDS) subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
TQB2928 injection is a fully humanized Immunoglobulin G 4 (IgG4) subtype monoclonal antibody targeting CD47. Azacitidine for injection is a nucleoside metabolism inhibitor that inhibits DeoxyriboNucleic Acid (DNA) methyltransferase, reduces DNA methylation and alters gene expression.
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGChongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGIncidence of Adverse Events (AEs)
Adverse events refer to all adverse medical events that occur after patients receive the experimental drug, which can be manifested as symptoms, signs, diseases or abnormal laboratory tests, but do not necessarily have a causal relationship with the experimental drug. Evaluated by Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0).
Time frame: Up to 2 years.
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs) evaluated by CTCAE 5.0.
Time frame: Up to 2 years.
Severity of serious adverse events (SAEs)
Severity of serious adverse events (SAEs) evaluated by CTCAE 5.0.
Time frame: Up to 2 years.
The area under the curve (AUC)
The area under the curve (AUC) of serum or plasma concentration of TQB2928
Time frame: Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.
Peak concentration (Cmax)
Maximum observed concentration of TQB2928
Time frame: Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.
Peak Time (Tmax)
Time to reach maximum concentration of TQB2928
Time frame: Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.
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Henan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe Third Xiangya Hospital of Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGThe First Hospital of Jilin University
Changchun, Jilin, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
NOT_YET_RECRUITINGShanghai Jiaotong University, School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGIncidence of anti-drug antibody (ADA)
Incidence of anti-drug antibody (ADA)
Time frame: Cycle1 Day1 and Cycle 5 Day 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; 90 days after last dose; Each cycle is 28 days.
AML: Objective Response Rate (ORR)
Defined as the percentage of Complete Response (CR) plus partial response (PR) plus Complete Response with incomplete hematological recovery (CRi) plus Morphological absence of leukemia status (MLFS) plus Complete Response with incomplete hematological recovery (CRh)
Time frame: Up to 2 years.
AML: Duration of Response (DOR)
For all patients with a best response of CR, CRh, CRi, MLFS, or PR, the time from the date of first achieved remission to the date of first documented disease progression/relapse/treatment failure or death, whichever occurs first.
Time frame: Up to 2 years.
AML: Time to CR+CRh+CRi
The time from the date of first TQB2928 injection treatment to the date of first CR, CRh or CRi among all patients whose best response was CR, CRh or CRi.
Time frame: Up to 2 years.
AML: Event-free survival (EFS)
Refers to the time from the date of receiving the first TQB2928 injection treatment to the first clearly recorded date of recurrence after remission, disease progression/treatment failure or death, whichever occurs first.
Time frame: Up to 2 years.
AML: Relapse-Free Survival (RFS)
Refers to the time from the date of remission to the first clearly recorded hematological relapse or death from any cause for patients who have achieved CR, CRh, or CRi, whichever occurs first.
Time frame: Up to 2 years.
AML: Overall survival (OS)
The time from the date of receiving the first TQB2928 injection treatment to the date of death from any cause.
Time frame: Up to 2 years.
MDS: Complete Response (CR) Rate
Proportion of patients whose best response is Complete Response
Time frame: Up to 2 years.
MDS: Objective Response Rate (ORR)
Proportion of patients with best response in CR, Complete molecular remission (mCR), PR or hematological remission
Time frame: Up to 2 years.
MDS: Improvement in Transfusion Independence
Proportion of patients who were transfusion dependent at baseline who were free of red-blood-cell (RBC)/platelet transfusion after first dose.
Time frame: Up to 2 years.
MDS: Progression Free Survival (PFS)
From the date of receiving the first TQB2928 injection treatment to the first documented time to investigator-assessed disease progression/relapse after CR or death from any cause.
Time frame: Up to 2 years.
MDS: Leukemia-free survival
From the date of receiving the first TQB2928 injection treatment to the blast cells in bone marrow/peripheral blood exceeding 20%, or the time of diagnosis of extramedullary acute leukemia, or death due to any cause.
Time frame: Up to 2 years.
MDS: Change from Baseline in Quality of Life (QoL) Score
Proportion of patients with a confirmed improvement of at least 10 points from baseline in overall health status/ QoL score assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30)
Time frame: Up to 2 years.
MDS: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Proportion of patients with confirmed improvement of at least 3 points from baseline in FACIT-Fatigue score
Time frame: Up to 2 years.