A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma

Prior treatment

• Received non-covalent BTK inhibitor treatment.
• Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of Rocbrutinib: Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy.

Other illness

• Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections.
• Disease affects the central nervous system.
• Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.

Lab values

• Subjects who have received the following treatments within 2 weeks before the first dose of Rocbrutinib: Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia.

• Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL.
• At least one measurable lesion.
• Subjects who have previously received the treatment regimen containing anti-CD20 and at least one BTKi treatment failed or relapsed after remission or intolerated; Or Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated, and are not suitable for treatment with anti-CD20.
• ECOG≤2.
• Adequate hematologic function.
• Adequate hepatic and renal function.
• Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \[and 2 years of non-therapy-induced amenorrhea\] or surgically sterile) to observe conventional and effective birth control.