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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04948788

Enrollment

102

Registered

2021-07-02

Start date

2021-10-31

Completion date

2023-10-31

Last updated

2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma

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.

Interventions

DRUGSHR1459 ；YY-20394

SHR1459 plus YY-20394

DRUGGemcitabine-Oxaliplatin

Gemcitabine-Oxaliplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

China

Contacts

Primary ContactWeiwei Wang

weiwei.wang@hengrui.com021-61053363

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026