A Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia

CTTQ

Status and phase

Not yet enrolling

Phase 1

Conditions

Chronic Myelogenous Leukemia

Treatments

Drug: TQB3911 tablets

Study type

Interventional

Funder types

Industry

Identifiers

TQB3911-I-01

Details and patient eligibility

About

Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
Age: ≥18 years old (when signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-2; Expected survival of more than 3 months;
During the screening period, the patients were identified as Chronic myelogenous leukemia-Chronic phase (CML-CP) or accelerated phase (AP) patients by bone marrow cell morphological examination, molecular biological examination or cytogenetic examination;
Chronic myelogenous leukemia (CML) patients who are intolerant to Tyrosine kinase inhibitors (TKI) drugs or whose therapeutic effect is not satisfactory (that is, the therapeutic response evaluation result is failure)
The main organs function well
Female subjects of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period.

Exclusion criteria

Had or was currently suffering from other malignant tumors within 5 years before the first medication
Combined with active central nervous system leukemia
Major surgical treatment and significant traumatic injury were received within 28 days before the start of study treatment
Previous history of myocardial infarction, pulmonary hypertension, or angina pectoris within 3 months before the first medication, or clinically significant arrhythmias such as ventricular tachycardia, complete left bundle branch block, and high atrioventricular block
Acute pancreatitis and a history of chronic pancreatitis within 12 months before the first medication
History of interstitial lung disease, radiation pneumonia requiring steroid treatment, or drug-related pneumonia
Patients with CML-CP who have achieved complete cytogenetic response (CCyR)
Received live attenuated vaccine within 4 weeks before the first dose, or planned to receive live attenuated vaccine during study participation
Use of drugs that may have caused QT prolongation or tip torsical tachycardia in the 7 days prior to initial administration, or continuation of these medications during the study period