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

Hengrui Medicine

Status and phase: Unknown; Phase 2

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

Treatments: Drug: Gemcitabine-Oxaliplatin; Drug: SHR1459 ；YY-20394

Study type: Interventional

Funder types: Industry

Identifiers

NCT04948788

SHR1459-II-201

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 3 patient groups

SHR1459 + YY-20394 (Stage 1)

Experimental group

Treatment:

Drug: SHR1459 ；YY-20394

Drug: SHR1459 ；YY-20394

SHR1459 + YY-20394 (Stage 2)

Experimental group

Treatment:

Drug: SHR1459 ；YY-20394

Drug: SHR1459 ；YY-20394

GemOx (Stage 2)

Experimental group

Treatment:

Drug: Gemcitabine-Oxaliplatin