Relapsed/Refractory Indolent NHLPhase 1/2NCT06981988

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

A Phase 1/2 study testing Linperlisib ； Rituximab in people with Relapsed/Refractory Indolent NHL, run by Jiangsu HengRui Medicine Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsed/Refractory Indolent NHL
What is being tested?: Linperlisib ； Rituximab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: Jun 2025to Feb 2027
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zhenyu Xiao contact

021-61053363

zhenyu.xiao.zx7@hengrui.com

About this study

Official 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

Conditions: Relapsed/Refractory Indolent NHL
Being tested: Linperlisib ； Rituximab
Medical subject headings: Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Linperlisib ； RituximabDrug
Linperlisib ； Rituximab

Study groups in NCT06981988
Study group	Role	What they receive
Linperlisib + Rituximab	Experimental	Not described Receives: Drug: Linperlisib ； Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

MTD （Maximum tolerated dose）of Linperlisib（Stage 1）
Measured: Subjects are evaluated for DLTs during the first 28-day cycle
RP2/3D（Recommended Phase II/III Dose) of Linperlisib （Stage 1）
Measured: The RP2/3D for Phase 2/3 will be selected at the end of Phase 1b, approximately 2 years
Complete response rate (CRR) assessed by Investigator（Stage 2）
Measured: up to 5 years
Progression-free Survival assessed by Investigator （Stage 2）
Measured: up to 5 years

Secondary outcomes (3)

Objective Response Rate (ORR) assessed by Investigator
Measured: up to 5 years
Duration of response (DOR) assessed by Investigator
Measured: up to 5 years
Incidence of Adverse Events (Linperlisib when combined with Rituximab)
Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2025Feb 2027

First posted21 May 2025
Study startJun 2025 (estimated)
Primary completionAug 2025 (estimated)
Study completionFeb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relapsed/Refractory Indolent NHLStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06981988
Sponsor's protocol ID: HRS3536-III-301
Status last verified: May 2025
First submitted: 4 Apr 2023
Last updated: 21 May 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided