A Study of Linperlisib (YY-20394) in Combination With Rituximab in Patients With Relapsed/Refractory Indolent NHL

Hengrui Medicine

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Relapsed/Refractory Indolent NHL

Treatments: Drug: Linperlisib ； Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06981988

HRS3536-III-301

Details and patient eligibility

About

The study is being conducted to evaluate the reasonable dosage, efficacy and safety of Linperlisib in combination with rituximab in subjects with relapsed/refractory (R/R) indolent non-hodgkin lymphoma(NHL) in adults.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients received at least 1 lines of systemic therapy
2. Previously received anti- CD20 treatment
3. Subjects must have at least one bi-dimensionally measurable lesion (nodal site Ldi > 1.5 cm or extranodal site Ldi > 1.0cm)
4. Patients must have an acceptable organ function

Exclusion criteria

1. Previously treated with PI3K inhibitors
2. Unresolved toxicity of CTCAE grade > 1 from prior anti-lymphoma therapy
3. Chemotherapy or other antitumor therapy within 14 days before starting cycle one
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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

Linperlisib + Rituximab

Experimental group

Treatment:

Drug: Linperlisib ； Rituximab