Follicular Lymphoma, Grade 1Phase 2NCT07545603
Clinical Study of XNW5004 Tablets in the Treatment of Relapsed and Refractory Follicular Lymphoma
A Phase 2 study testing XNW5004 tablets in people with Follicular Lymphoma, Grade 1 and Follicular Lymphoma, Grade 2, run by Evopoint Biosciences Inc. at 1 site in China.
Trial summary
This is a single-arm, open-label, multicenter Phase II clinical study designed to enroll 65 subjects with relapsed or refractory follicular lymphoma (EZH2 wild-type). The study procedures include a pre-screening phase, screening phase, treatment phase, and follow-up phase.Eligible subjects will enter the treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma, Grade 1, Follicular Lymphoma, Grade 2, Follicular Lymphoma, Grade 3
- What is being tested?
- XNW5004 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2026to 31 Dec 2028
- Phase
- Phase 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
- Age ≥ 18 years; no gender restriction.
- Histologically confirmed follicular lymphoma (FL) grade 1-3a (classic FL per WHO 2022 classification) with wild-type EZH2, as assessed at the study site.
- Relapsed or refractory disease following at least 3 prior lines of systemic therapy, including at least one line with adequate treatment using a commercially available anti-CD20 monoclonal antibody and at least one line with adequate treatment using a novel agent (including but not limited to PI3K inhibitors, CD3×CD20 bispecific antibodies, BTK inhibitors, etc.):
- Adequate anti-CD20 mAb treatment: at least 4 cycles of continuous therapy or disease progression during treatment; subjects not meeting this criterion may be included only with a valid justification (e.g., intolerance).
- Adequate novel agent treatment: failure to achieve response, disease progression during treatment, or treatment discontinuation due to intolerance (intolerance defined as meeting treatment discontinuation criteria per the package insert).
- Relapsed disease: relapse ≥6 months after achieving response to any line of therapy.
Show all 28Show fewer
- Refractory disease, defined by any of the following:
- Response duration <6 months and ineligible for or unwilling to undergo autologous hematopoietic stem cell transplantation (auto-HSCT); Failure to achieve response after at least 4 cycles of treatment; Best response or treatment discontinuation due to progressive disease, regardless of number of cycles; Relapse after auto-HSCT.
- Prior radiotherapy is permitted; radiotherapy alone is not considered a systemic therapy.
- Availability of sufficient biological samples for EZH2 mutation testing.
- At least one measurable lesion: nodal lesion with longest diameter >1.5 cm; extranodal lesion with longest diameter >1.0 cm and FDG-PET positive.
- Life expectancy ≥12 weeks.
- ECOG performance status 0 or 1.
- Adequate organ function:
- Hematologic function:
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L (≥1.0×10⁹/L if bone marrow involvement); no G-CSF within 1 week or long-acting G-CSF within 2 weeks before screening CBC.
- Platelets ≥90×10⁹/L (≥75×10⁹/L if bone marrow involvement); no platelet transfusion or TPO receptor agonist within 1 week before screening CBC.
- Hemoglobin ≥90 g/L (≥80 g/L if bone marrow involvement); no red blood cell transfusion or EPO within 1 week before screening CBC.
- Hepatic function:
- Total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert's syndrome); ALT and AST ≤2.5×ULN; ≤5×ULN with liver involvement; ALP ≤5×ULN with liver and/or bone involvement.
- Renal function:
- Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL/min by Cockcroft-Gault equation.
- Left ventricular ejection fraction (LVEF) ≥50%. INR ≤1.5×ULN, or PT and APTT ≤1.5×ULN.
- Women of childbearing potential must have a negative serum pregnancy test at study entry and agree to use highly effective contraception from study start until at least 6 months after last dose of study drug.
- Non-childbearing potential is defined as:
- Amenorrhea ≥12 months with confirmation of menopausal status by hormonal testing and specialist assessment; OR Bilateral oophorectomy, hysterectomy, or tubal ligation ≥6 weeks before screening.
- Male subjects must agree to use effective contraception and refrain from sperm donation from study start until at least 6 months after last dose of study drug.
- Signed and dated written informed consent prior to any study-specific procedures, and ability to comply with study visits and protocol-required assessments.
Who cannot join
- Follicular lymphoma grade 3b, mixed histology, potential for transformation, or documented histologic transformation.
- Prior treatment with an EZH2 inhibitor or EZH1/2 inhibitor (including but not limited to tazemetostat).
- Known hypersensitivity to the investigational product, its active ingredients, or excipients.
- Received chemotherapy, immunotherapy, radiotherapy, targeted therapy, antitumor traditional Chinese medicine, or other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; received CAR-T therapy within 12 weeks prior to the first dose; underwent autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months prior to the first dose.
- Received investigational antitemporal agents not approved in China within 28 days prior to initiation of study treatment.
- Underwent major surgery within 4 weeks prior to initiation of study treatment, or planning major surgery during the study period (excluding procedures such as puncture or lymph node biopsy).
Show all 34Show fewer
- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Disease requiring systemic therapy with corticosteroids (> 10 mg prednisone daily or equivalent) or other immunosuppressive agents within 14 days prior to study drug administration. Inhaled or topical steroids and adrenal replacement therapy with ≤ 10 mg prednisone daily or equivalent are permitted in the absence of active autoimmune disease.
- Received moderate or strong CYP3A4 inhibitors/inducers within 14 days prior to the first dose (see Appendix 4 for details).
- Received live or live-attenuated viral vaccines within 28 days prior to dosing. Inactivated vaccines are permitted.
- History of psychoactive substance abuse or drug addiction (except for insomnia with stable, long-term therapy as assessed by the investigator).
- Toxicities from prior antitumor therapy not recovered to ≤ Grade 1 per NCI-CTCAE version 5.0, except for toxicities deemed by the investigator not to affect patient safety evaluation (e.g., alopecia).
- History of another malignancy within 3 years prior to enrollment that does not meet criteria for clinical cure, except for adequately treated and cured basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
- Previous or current central nervous system involvement by lymphoma.
- Previous or current testicular or breast involvement by lymphoma.
- Previous or current hemophagocytic lymphohistiocytosis.
- Previous or current primary or secondary hematologic disorders other than the primary malignant neoplasm that may affect bone marrow function, including immune thrombocytopenia, autoimmune hemolytic anemia, and aplastic anemia.
- Previous or current acute myeloid leukemia (AML).
- Previous or current T-lymphoblastic lymphoma (T-LBL) or T-lymphoblastic leukemia (T-ALL).
- History of any myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal laboratory findings associated with MDS or myeloproliferative neoplasms (MPN).
- Previous or current central nervous system disorders including, but not limited to: epilepsy, paralysis, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, etc. (excluding stroke with adequate treatment and stable disease for ≥12 months before first dose, or asymptomatic lacunar infarction not requiring treatment).
- Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- Acute myocardial infarction within 12 months prior to first dose; Unstable angina; Congestive heart failure (NYHA Class III or IV, see Appendix 5); Uncontrolled serious arrhythmia, hypertension ≥ 150/100 mmHg; Prolonged QTcF interval (> 450 ms in males, > 470 ms in females) calculated by Fredericia's formula (see Appendix 6); History of other major cardiovascular disease (e.g., valve replacement, coronary artery bypass grafting, etc.).
- Tumor invasion of adjacent vital organs, gastrointestinal tract, or blood vessels (e.g., heart and pericardium, trachea, esophagus, aorta, superior vena cava) with risk of hemorrhage, or risk of esophagotracheal fistula, esophagopleural fistula, gastrointestinal perforation, etc.
- Clinically symptomatic pleural effusion, ascites, or pericardial effusion poorly controlled despite repeated treatment.
- Unexplained fever with body temperature > 38.0 °C (including tumor fever); body temperature must be within normal range for 2 weeks prior to first dose.
- Systemic active severe infection: at least 2 weeks washout after completion of antifungal therapy (intravenous or oral), at least 1 week washout after completion of other intravenous antimicrobial therapy, and oral antimicrobial therapy must be discontinued prior to first dose.
- History of tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year prior without adequate anti-tuberculosis treatment.
- Positive HIV test or positive syphilis (Anti-TP) test (patients with negative non-treponemal test and syphilis deemed cured by the investigator are not excluded).
- Positive HBsAg with HBV-DNA above the lower limit of detection, or anti-HBc positive with HBV-DNA above the lower limit of detection; positive HCV antibody with HCV-RNA above the lower limit of detection.
- Inability to swallow, or active gastrointestinal inflammation, chronic diarrhea, known diverticular disease, or history of gastrectomy, gastric banding, or other conditions affecting drug absorption. Proton pump inhibitor-treated gastroesophageal reflux is permitted if no potential drug-drug interaction exists.
- Known bleeding disorders such as von Willebrand disease or hemophilia.
- Female patients who are pregnant or breastfeeding.
- Patients who may be unable to complete the study for any other reason, or whom the investigator deems ineligible for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospitial
Beijing, Beijing Municipality, 100142
About this study
Official title: Phase II Study of XNW5004 in the Treatment of Patients With Relapsed or Refractory Follicular Lymphoma (EZH2 Wild-type)
This is a single-arm, open-label, multicenter Phase II clinical study designed to enroll 65 subjects with relapsed or refractory follicular lymphoma (EZH2 wild-type).
The study procedures include a pre-screening phase, screening phase, treatment phase, and follow-up phase.Eligible subjects will enter the treatment phase and receive 1200 mg of XNW5004 tablets twice daily, with a 10-14-hour interval between doses. Each treatment cycle consists of 28 consecutive days of dosing, and pharmacokinetic (PK) blood samples will be collected at the designated time points.Safety assessments and quality-of-life (QoL) assessments will be performed in accordance with the study follow-up schedule.Tumor assessments will be conducted every 8 weeks (every 2 cycles) for the first 48 weeks after the first dose (Cycles 1 to 12), and every 12 weeks (every 3 cycles) thereafter (from Cycle 13 onward).Subjects who discontinue treatment must complete an end-of-treatment visit and safety follow-up.
For long-term follow-up:Subjects who terminate treatment for reasons other than disease progression and do not initiate new antineoplastic therapy will continue tumor assessments per the original schedule until disease progression, initiation of new antineoplastic therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.For all patients (excluding those who withdraw informed consent, are lost to follow-up, or die), survival follow-up will be performed every 12 weeks (±7 days) starting from the date of the last tumor assessment, until withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.
- Conditions
- Follicular Lymphoma, Grade 1, Follicular Lymphoma, Grade 2, Follicular Lymphoma, Grade 3, Follicular Lymphoma Grade 3A
- Being tested
- XNW5004 tablets
- Keywords
- Follicular Lymphoma, Phrase II
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XNW5004 tabletsDrug
Oral administration of XNW5004 Tablets 1200 mg twice daily with a 10-14 hour interval for 28 consecutive days as one treatment cycle in patients with relapsed or refractory follicular lymphoma (EZH2 wild-type).
| Study group | Role | What they receive |
|---|---|---|
| XNW5004 | Experimental | XNW5004 Tablets 1200 mg, twice daily, at an interval of 10-14 hours, with 28 consecutive days of administration as one treatment cycle. Receives: Drug: XNW5004 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate (ORR) as assessed by Independent Review Committee (IRC) in patients with relapsed or refractory follicular lymphoma (EZH2 wild-type) treated with XNW5004 Tablets.
Measured: 24months
Secondary outcomes (14)
DCR
Other efficacy endpoints as assessed by IRC, including disease control rate (DCR)
Measured: 24 months
TTR
Other efficacy endpoints as assessed by IRC, including disease control rate (TTR)
Measured: 24 months
DOR
Other efficacy endpoints as assessed by IRC, including duration of response (DOR)
Measured: 24 months
PFS
Other efficacy endpoints as assessed by IRC, including disease control rate (PFS)
Measured: 24 months
OS
Evaluate the overall survival (OS) of the target patient.
Measured: 24 months
ORR
Efficacy endpoints based on investigator assessment, such as ORR.
Measured: 24months
DCR
Efficacy endpoints based on investigator assessment, such as DCR.
Measured: 24months
DOR
Efficacy endpoints based on investigator assessment, such as DOR.
Measured: 24months
TTR
Efficacy endpoints based on investigator assessment, such as TTR.
Measured: 24months
PFS
Efficacy endpoints based on investigator assessment, such as PFS.
Measured: 24months
Evaluate patients' quality of life
To evaluate patients' quality of life by EQ-5D-5L assessment
Measured: 24months
Evaluate patients' quality of life
To evaluate patients' quality of life by FACT-Lym assessment
Measured: 24months
Plasma concentration measurement
Measurement of plasma concentrations of the test drug and its metabolites
Measured: 24months
Safety endpoint
The incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as vital signs, electrocardiogram, and laboratory abnormalities were analyzed
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start14 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Lymphoma, Grade 1Studies of the same condition, open and under way.
- More trials run by Evopoint Biosciences Inc.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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evopoint Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuqin Song, PhD, Principal investigator, Beijing Cancer Hospitial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545603
- Sponsor's protocol ID
- XNW5004-II-01
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of XNW5004 in the Treatment of Patients With Relapsed or Refractory Follicular Lymphoma (EZH2 Wild-type)
- ClinicalTrials.gov ID
- NCT07545603
- Acronym / sponsor ID
- XNW5004-II-01
- Conditions
- Follicular Lymphoma, Grade 1, Follicular Lymphoma, Grade 2, Follicular Lymphoma, Grade 3, Follicular Lymphoma Grade 3A
- Keywords
- Follicular Lymphoma, Phrase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Evopoint Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Apr 2026 (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.
This is a single-arm, open-label, multicenter Phase II clinical study designed to enroll 65 subjects with relapsed or refractory follicular lymphoma (EZH2 wild-type).
The study procedures include a pre-screening phase, screening phase, treatment phase, and follow-up phase.Eligible subjects will enter the treatment phase and receive 1200 mg of XNW5004 tablets twice daily, with a 10-14-hour interval between doses. Each treatment cycle consists of 28 consecutive days of dosing, and pharmacokinetic (PK) blood samples will be collected at the designated time points.Safety assessments and quality-of-life (QoL) assessments will be performed in accordance with the study follow-up schedule.Tumor assessments will be conducted every 8 weeks (every 2 cycles) for the first 48 weeks after the first dose (Cycles 1 to 12), and every 12 weeks (every 3 cycles) thereafter (from Cycle 13 onward).Subjects who discontinue treatment must complete an end-of-treatment visit and safety follow-up.
For long-term follow-up:Subjects who terminate treatment for reasons other than disease progression and do not initiate new antineoplastic therapy will continue tumor assessments per the original schedule until disease progression, initiation of new antineoplastic therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.For all patients (excluding those who withdraw informed consent, are lost to follow-up, or die), survival follow-up will be performed every 12 weeks (±7 days) starting from the date of the last tumor assessment, until withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XNW5004 | Experimental | Drug: XNW5004 tabletsXNW5004 Tablets 1200 mg, twice daily, at an interval of 10-14 hours, with 28 consecutive days of administration as one treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Age ≥ 18 years; no gender restriction.
- Histologically confirmed follicular lymphoma (FL) grade 1-3a (classic FL per WHO 2022 classification) with wild-type EZH2, as assessed at the study site.
- Relapsed or refractory disease following at least 3 prior lines of systemic therapy, including at least one line with adequate treatment using a commercially available anti-CD20 monoclonal antibody and at least one line with adequate treatment using a novel agent (including but not limited to PI3K inhibitors, CD3×CD20 bispecific antibodies, BTK inhibitors, etc.):
- Adequate anti-CD20 mAb treatment: at least 4 cycles of continuous therapy or disease progression during treatment; subjects not meeting this criterion may be included only with a valid justification (e.g., intolerance).
- Adequate novel agent treatment: failure to achieve response, disease progression during treatment, or treatment discontinuation due to intolerance (intolerance defined as meeting treatment discontinuation criteria per the package insert).
Key exclusion criteria (34 listed)
- Follicular lymphoma grade 3b, mixed histology, potential for transformation, or documented histologic transformation.
- Prior treatment with an EZH2 inhibitor or EZH1/2 inhibitor (including but not limited to tazemetostat).
- Known hypersensitivity to the investigational product, its active ingredients, or excipients.
- Received chemotherapy, immunotherapy, radiotherapy, targeted therapy, antitumor traditional Chinese medicine, or other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; received CAR-T therapy within 12 weeks prior to the first dose; underwent autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months prior to the first dose.
- Received investigational antitemporal agents not approved in China within 28 days prior to initiation of study treatment.
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 |
|---|---|---|
| XNW5004 tabletsOral administration of XNW5004 Tablets 1200 mg twice daily with a 10-14 hour interval for 28 consecutive days as one treatment cycle in patients with relapsed or refractory follicular lymphoma (EZH2 wild-type). | Drug | XNW5004 |
Primary outcome
ORR
Time frame: 24months
Objective Response Rate (ORR) as assessed by Independent Review Committee (IRC) in patients with relapsed or refractory follicular lymphoma (EZH2 wild-type) treated with XNW5004 Tablets.
14 secondary outcomes
DCR
Time frame: 24 months
TTR
Time frame: 24 months
DOR
Time frame: 24 months
PFS
Time frame: 24 months
OS
Time frame: 24 months
ORR
Time frame: 24months
DCR
Time frame: 24months
DOR
Time frame: 24months
TTR
Time frame: 24months
PFS
Time frame: 24months
Evaluate patients' quality of life
Time frame: 24months
Evaluate patients' quality of life
Time frame: 24months
Plasma concentration measurement
Time frame: 24months
Safety endpoint
Time frame: 24 months
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 22 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Follicular Lymphoma, Grade 1
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
Active, not recruitingPhase 1/2
Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)
Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
RecruitingPhase 2
Acalabrutinib, Lenalidomide, and Rituximab for the Treatment of CD20 Positive Stage III-IV, Grade 1-3a Follicular Lymphoma
Ann Arbor Stage III Grade 1 Follicular Lymphoma, Ann Arbor Stage III Grade 2 Follicular Lymphoma
Recruiting
Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers
Cognitive Impairment, Mild, Dementia, Mild
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.
Yuqin Song, PhD principal investigator
Beijing Cancer Hospitial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XNW5004 tablets in people with Follicular Lymphoma, Grade 1 and Follicular Lymphoma, Grade 2, run by Evopoint Biosciences Inc. at 1 site in China.
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 28 inclusion and 34 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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 Yuqin Song (+86 010-88196118, songyuqin622@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 24months). 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 22 Apr 2026.