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NCT Number: NCT06981988

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

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.

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Key information

Conditions

Relapsed/Refractory Indolent NHL Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previously treated with PI3K inhibitors
  • Unresolved toxicity of CTCAE grade > 1 from prior anti-lymphoma therapy
  • Chemotherapy or other antitumor therapy within 14 days before starting cycle one
  • 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

Treatment and study plan

Linperlisib ； Rituximab

Drug

Linperlisib ； Rituximab

Primary outcomes

  1. MTD （Maximum tolerated dose）of Linperlisib（Stage 1）

    Time frame: Subjects are evaluated for DLTs during the first 28-day cycle

  2. RP2/3D（Recommended Phase II/III Dose) of Linperlisib （Stage 1）

    Time frame: The RP2/3D for Phase 2/3 will be selected at the end of Phase 1b, approximately 2 years

  3. Complete response rate (CRR) assessed by Investigator（Stage 2）

    Time frame: up to 5 years

  4. Progression-free Survival assessed by Investigator （Stage 2）

    Time frame: up to 5 years

Secondary outcomes

  1. Objective Response Rate (ORR) assessed by Investigator

    Time frame: up to 5 years

  2. Duration of response (DOR) assessed by Investigator

    Time frame: up to 5 years

  3. Incidence of Adverse Events (Linperlisib when combined with Rituximab)

    Time frame: up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenyu Xiao

CONTACT

[email protected]

021-61053363

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Study to Explore the Dosage and Efficacy of Linperlisib in Combination With Rituximab and to Validate the Efficacy of Linperlisib in Patients With Relapsed/Refractory Indolent NHL

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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