a study of tq-b3525 in subjects with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma

Conditions: Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Summary: this is a study to evaluate the efficacy and safety of tq-b3525 in subjects with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.


Eligibility criteria:
inclusion criteria: * 1.understood and signed an informed consent form; 2. 18 years and older, eastern cooperative oncology group(ecog) performance status score of 0 to 2, life expectancy ≥ 3 months; 3.chronic lymphocytic leukemia/small lymphocytic lymphoma diagnosed by flow cytometry or pathology, and meets at least one of the criteria for active diseases requiring treatment in iwcll2008; 4.has received at least one line of previous treatment, the latest treatment confirmed no objective response, or disease progress after treatment; 5.has at least one measurable lesion; 6. adequate organ system function; 7. male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；no pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration. exclusion criteria: -1. has richter's transformation or prolymphocytic leukemia (pll)； 2. has central nervous system violation; 3. has uncontrolled primary autoimmune cytopenias, including autoimmune hemolytic anemia (aiha), idiopathic thrombocytopenic purpura (itp), etc； 4. has received other pi3k inhibitors or car-t treatments; 5. has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 6.diagnosed as type i diabetes or uncontrollable type ii diabetes, or fasting blood glucose\> 8.9 mmol/l or glycosylated hemoglobin (hba1c)\> 8.5% during the screening period; 7. has interstitial lung disease or drug-induced interstitial lung disease history; 8. has a history of immunodeficiency diseases; 9. has multiple factors affecting oral medication; 10. has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 11. has received systemic steroid treatment within 7 days before the first administration; 12. has received other systemic anti-tumor medications within 4 weeks before the first administration, or still within the 5 half-life of the medication, which occurs first; 13.has active infections within 4 weeks before the first administration; 14.has received surgery, or unhealed wounds within 4 weeks before the first administration; 15. has a history of autologous hematopoietic stem cell transplant within 3 months; 16. has a history of allogeneic hematopoietic stem cell transplant; 17. grade ii or higher cardiovascular disease within 6 months before the first administration; 18.qtcf \> 480ms, lvef \ 1g within 7 days; 20. has active hepatitis b or c; 21. has psychotropic substances abuse or a mental disorder; 22. has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion. 21. has psychotropic substances abuse or a mental disorder;