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

Inclusion Criteria:

1. Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosedwith MCL.

2. At least one measurable lesion.

3. Subjects who have previously received the treatment regimen containing anti-CD20 andat least one BTKi treatment failed or relapsed after remission or intolerated; OrSubjects who have previously received BTK inhibitors treatment failed or relapsedafter remission or intolerated, and are not suitable for treatment with anti-CD20.

4. ECOG≤2.

5. Adequate hematologic function.

6. Adequate hepatic and renal function.

7. Willingness of men and women of reproductive potential (defined as followingmenarche and not postmenopausal [and 2 years of non-therapy-induced amenorrhea] orsurgically sterile) to observe conventional and effective birth control.

Exclusion Criteria:

1. Received non-covalent BTK inhibitor treatment.

2. Subjects who have received the following treatments within 4 weeks or 5 half-livesbefore the first dose of Rocbrutinib: Antitumor therapies including myelosuppressivechemotherapy, targeted therapy, biological therapy and/or immunotherapy; Anyinvestigational treatment; Patients who have undergone major surgery, severe traumaor radiotherapy.

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

4. Disease states where clinical manifestations may be difficult to control, includingHIV, HBV, HCV, syphilis positive or active bacterial and fungal infections.

5. Disease affects the central nervous system.

6. Any gastrointestinal conditions that may severely affect the study drug absorptionor pharmacokinetic parameters.