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

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04948788

Collaborator

(none)

102

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma	Drug: SHR1459 ；YY-20394 Drug: SHR1459 ；YY-20394 Drug: Gemcitabine-Oxaliplatin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I/ II Study of SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma in Adults

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SHR1459 + YY-20394 (Stage 1)	Drug: SHR1459 ；YY-20394 SHR1459 plus YY-20394
Experimental: SHR1459 + YY-20394 (Stage 2)	Drug: SHR1459 ；YY-20394 SHR1459 plus YY-20394
Experimental: GemOx (Stage 2)	Drug: Gemcitabine-Oxaliplatin Gemcitabine-Oxaliplatin

Arm

Intervention/Treatment

Experimental: SHR1459 + YY-20394 (Stage 1)

Drug: SHR1459 ；YY-20394

SHR1459 plus YY-20394

Experimental: SHR1459 + YY-20394 (Stage 2)

Drug: SHR1459 ；YY-20394

SHR1459 plus YY-20394

Experimental: GemOx (Stage 2)

Drug: Gemcitabine-Oxaliplatin

Gemcitabine-Oxaliplatin

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed diagnosis of B-cell NHL such as DLBCL, FL and MCL
Patients received at least 2 lines of systemic therapy
Previously received anti- CD20 treatment
Patients in stage II should also be unsuitable or unwilling to receive allogeneic hematopoietic stem cell transplantation
Patients must have an acceptable organ function

Exclusion Criteria:

Previously treated with PI3K inhibitors or BTK inhibitors
Unresolved toxicity of CTCAE grade > 1 from prior anti-lymphoma therapy
Chemotherapy or other investigational therapy within 28 days (or 5 times the half-life time, whichever is shorter) before starting cycle 1
Significant concurrent medical disease or condition which according to the investigators' judgement
Active hepatitis B, C or HIV infection
Infection requiring treatment 2 weeks prior to the first dosing