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

An Open Label, Single Arm, Multicenter Phase II Study of the Efficacy and Safety of Rocbrutinib Monotherapy for Recurrent or Refractory Mantle Cell Lymphoma

This is an open-label, single arm, multi-center Phase 2 study of oral Rocbrutinib in patients with mantle cell lymphoma who are failed or relapsed after remission or intolerated to Bruton's tyrosine kinase (BTK) inhibitor.

Inclusion Criteria:

1. Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL.
2. At least one measurable lesion.
3. 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.
4. ECOG≤2.
5. Adequate hematologic function.
6. Adequate hepatic and renal function.
7. 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.

Exclusion Criteria:

1. Received non-covalent BTK inhibitor treatment.
2. 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.
3. 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.
4. Disease states where clinical manifestations may be difficult to control, including HIV, 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 absorption or pharmacokinetic parameters.