ICP-248 in Combination with Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years.

2. CLL/SLL is diagnosed by histopathology and/or flow cytometry according to the 2016World Health Organization (WHO) classification criteria for lymphohematopoieticneoplasms or meeting the criteria of 2018 International Workshop on ChronicLymphocytic Leukemia (iwCLL 2018):

3. Having an indication for treatment that meets the criteria for iwCLL 2018

4. Subjects must have measurable lesion according to the Lugano 2014 AssessmentCriteria.

5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS)score of ≤ 2 and a life expectancy of ≥ 6 months.

6. Adequate hematologic function

7. Patients with basically normal coagulation function

8. Patients with adequate hepatic, renal, pulmonary and cardiac functions

9. Subjects are able to communicate with the investigator well and to complete thestudy as specified in the study.

10. Before the trial, the subjects shall understand the nature, significance, possiblebenefits, inconveniences and potential risks, as well as the study procedures of thetrial in detail and voluntarily sign the written Informed Consent Form (ICF).

Exclusion Criteria:

1. Central nervous system involvement.

2. Concomitant Richter transformation.

3. Prior systemic treatment, excluding emergency pretreatment to reduce white bloodcells and relieve leukostasis.

4. Requireing continuous glucocorticoid support or glucocorticoid therapy within 5days.

5. History of allogeneic stem cell transplantation.

6. Major organ surgery (excluding aspiration biopsy) or significant trauma within 28days prior to the first dose of the investigational drug or require elective surgeryduring the trial.

7. Presence of active infection that requires intravenous anti-infective therapy.

8. Hepatitis B or C virus infection.

9. History of immunodeficiency disease or Significant cardiovascular disease

10. Central nervous system disorders or Severe bleeding disorder

11. Alcohol or drug dependence.

12. Mental disorders or poor compliance.