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..
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
- Are there results?
- Not yet: the study is under way
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.
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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06981988
- Acronym / sponsor ID
- HRS3536-III-301
- Conditions
- Relapsed/Refractory Indolent NHL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linperlisib + Rituximab | Experimental | Drug: Linperlisib ； Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linperlisib ； RituximabLinperlisib ； Rituximab | Drug | Linperlisib + Rituximab |
Primary outcome
MTD （Maximum tolerated dose）of Linperlisib（Stage 1）
Time frame: Subjects are evaluated for DLTs during the first 28-day cycle
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
Complete response rate (CRR) assessed by Investigator（Stage 2）
Time frame: up to 5 years
Progression-free Survival assessed by Investigator （Stage 2）
Time frame: up to 5 years
3 secondary outcomes
Objective Response Rate (ORR) assessed by Investigator
Time frame: up to 5 years
Duration of response (DOR) assessed by Investigator
Time frame: up to 5 years
Incidence of Adverse Events (Linperlisib when combined with Rituximab)
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Linperlisib ； Rituximab in people with Relapsed/Refractory Indolent NHL, run by Jiangsu HengRui Medicine Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenyu Xiao (021-61053363, zhenyu.xiao.zx7@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD （Maximum tolerated dose）of Linperlisib（Stage 1） (time frame: Subjects are evaluated for DLTs during the first 28-day cycle). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.