SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is evaluating the efficacy, and safety of SHR1459 combined with YY-20394 for Recurrent and refractory B-cell non-Hodgkin's lymphoma in adults.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Gemcitabine; Oxaliplatin

Criteria

Inclusion Criteria:

1. Histologically confirmed diagnosis of B-cell NHL such as DLBCL, FL and MCL

2. Patients received at least 2 lines of systemic therapy

3. Previously received anti- CD20 treatment

4. Patients in stage II should also be unsuitable or unwilling to receive allogeneic hematopoietic stem cell transplantation

5. Patients must have an acceptable organ function

Exclusion Criteria:

1. Previously treated with PI3K inhibitors or BTK inhibitors

2. Unresolved toxicity of CTCAE grade > 1 from prior anti-lymphoma therapy

3. Chemotherapy or other investigational therapy within 28 days (or 5 times the half-life time, whichever is shorter) before starting cycle 1

4. Significant concurrent medical disease or condition which according to the investigators' judgement

5. Active hepatitis B, C or HIV infection

6. Infection requiring treatment 2 weeks prior to the first dosing