Evaluating Different Doses of Orelabrutinib in MCL

Prior treatment

• Adequate treatment with BTK inhibitors.
• Subjects who have received the treatment or drug restricted in the protocol within the time specified for the first use of the investigational drug.
• The last use of a potent CYP3A inhibitor or potent CYP3A inducer (including food, western medicine, and Chinese medicine) was less than 2 weeks (or less than 5 half-lives, depending on the time) from the first trial, or plan to take a potent CYP3A inhibitor or potent CYP3A inducer drug or food during the study period.
• History of other active malignant diseases within 2 years prior to screening.
• Toxicity of previous anticancer therapy was still ≥ grade 2 at the start of study therapy (according to CTCAE V5.0).

Other illness

• Have a history of severe allergic disease and a history of severe drug allergy.
• Subjects with systemic bacterial, viral, fungal (other than nail fungal infections) or parasitic infections with poorly controlled activity.
• Indicates active hepatitis B or C virus infection.
• There are diseases that are excluded from the criteria in the programme.
• History of severe bleeding disorder.
• People with a known history of alcohol or drug abuse.
• Subjects with mental disorders or poor compliance.
• Other conditions deemed unsuitable for participation in this study by the investigator.

Other

• Pregnant or lactating female subjects.

• Male and female subjects ≥ 18 years of age.
• Mantle cell lymphoma (MCL) confirmed by histopathology.
• Subjects who have not previously received standard systemic care and relapsing/refractory subjects who have previously received standard systemic care.
• At least one measurable lesion.
• ECOG Physical fitness score 0-2 points.
• Expected survival time ≥ 4 months.
• Full hematology function.
• Blood clotting function is basically normal.
• Subjects with basically normal liver, kidney and heart function.
• Subject voluntarily signs a written ICF.
• The serum pregnancy test of female subjects with fertility potential was negative within 7 days before the first dosing.
• Female subjects with reproductive potential or male subjects and their partners must agree to use effective contraception for at least 6 months from signing the ICF until the last dose of the study drug.