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

Phase 2

• Conditions: Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma
• Interventions: Drug: Gemcitabine-Oxaliplatin; Drug: SHR1459 ；YY-20394

• Registration Number: NCT04948788
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-02
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-28
• Study Start: 2021-10
• Primary Completion: 2023-04
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GemOx (Stage 2)	Gemcitabine-Oxaliplatin	-
SHR1459 + YY-20394 (Stage 2)	SHR1459 ；YY-20394	-
SHR1459 + YY-20394 (Stage 1)	SHR1459 ；YY-20394	-

Primary Outcome Measures

Name	Time	Method
Stage 1: MTD （Maximum tolerated dose）or RP2D（Recommended Phase II Dose) of SHR1459 and YY-20394;	Minimum observation period is 28 days for the maximum dose cohort
Stage 2: Overall response rate (ORR)	8 weeks after last patient first visit (LPFV)

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	At every treatment and follow up visit until disease progression. Expected to be for up to 6 months

Trial Locations

Locations (1)

Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School; 🇨🇳 Shanghai, Shanghai, China