System Lupus Erythematosus(SLE)Phase 1NCT07512947
Study of YKST02 Alone or in Combination With YK012 in Patients With Active or Refractory Systemic Lupus Erythematosus
A Phase 1 study testing YKST02 and YK012 in people with System Lupus Erythematosus(SLE), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YKST02 administered alone or in combination with YK012 in participants with active or refractory systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- System Lupus Erythematosus(SLE)
- What is being tested?
- YKST02 and YK012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2026to 30 Jun 2028
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria, with active disease defined as SLEDAI-2K ≥6 at screening, and considered to have inadequate response, intolerance, or ineligibility to standard therapy.
- Have received standard therapy for SLE for at least 12 weeks prior to screening (including corticosteroids and at least one immunosuppressant and/or biologic agent), or are intolerant to or unsuitable for such therapies.
- Receiving stable background therapy prior to enrollment, including stable doses of corticosteroids (within 2 weeks prior to enrollment), and/or antimalarial agents or one immunosuppressant (within 4 weeks prior to enrollment).
- Positive for at least one lupus-related autoantibody at screening (e.g., anti-dsDNA, antinuclear antibody, or anti-Smith antibody).
- Able and willing to provide written informed consent and comply with study procedures.
Who cannot join
- Known hypersensitivity to monoclonal antibodies, immunoglobulins, or any component of the study drug.
- Prior treatment with B cell-depleting therapies, B cell-targeting biologics, or other biologic or targeted therapies within protocol-defined washout periods.
- Receipt of intravenous immunoglobulin or plasma exchange within protocol-defined washout periods.
- Receipt of live or attenuated vaccines within 4 weeks prior to enrollment.
- Presence of other active autoimmune diseases or inflammatory conditions (except secondary Sjögren's syndrome) that may interfere with assessment of SLE disease activity.
- History of major organ transplantation.
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- History of malignancy within the past 5 years (except adequately treated low-risk cancers).
- Clinically significant or uncontrolled cardiovascular, cerebrovascular, neurological, hepatic, renal, hematologic, or metabolic diseases.
- Active or uncontrolled infections, including tuberculosis (active or untreated latent), hepatitis B or C, human immunodeficiency virus (HIV), or other clinically significant infections.
- Active or severe neuropsychiatric conditions that may interfere with study participation.
- Uncontrolled hypertension or clinically significant electrocardiogram abnormalities (including prolonged QT interval).
- Clinically significant abnormal laboratory findings at screening (e.g., severe cytopenias, impaired liver or renal function, or coagulation abnormalities).
- Recent major surgery or planned surgery during the study period.
- Recent use of investigational agents or participation in another clinical study within 4 weeks prior to enrollment.
- Pregnant or breastfeeding women, or women of childbearing potential unwilling to use effective contraception during the study and for an appropriate period after the last dose.
- Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Qiubai Li, MD, PhD, +86 27 85726338, qiubaili@hust.edu.cn
Qiubai Li, MD, PhD
About this study
Official title: A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of YKST02 as Monotherapy or in Combination With YK012 in Patients With Active or Refractory Systemic Lupus Erythematosus
The purpose of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YKST02 administered alone or in combination with YK012 in participants with active or refractory systemic lupus erythematosus (SLE).
The main questions this study aims to address are:
Read more
- Whether YKST02 alone or in combination with YK012 is safe and well tolerated in participants with active or refractory SLE
- Whether YKST02 alone or in combination with YK012 demonstrates preliminary efficacy in treating SLE
- What the PK and PD characteristics of YKST02 are when administered alone or in combination with YK012
- Whether treatment with YKST02 induces anti-drug antibody responses
Participants will:
- Receive intravenous infusions of YKST02 alone or in combination with YK012 according to the assigned cohort
- Undergo safety assessments, including monitoring for adverse events
- Provide blood samples for PK, PD, and immunogenicity analyses
- Be followed for approximately 49 weeks to assess safety and efficacy
Read the detailed description
This is a single-center, open-label clinical trial evaluating YKST02 administered alone or in combination with YK012 in participants with active or refractory systemic lupus erythematosus (SLE). The study is designed to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy.
The study consists of two cohorts:
Cohort 1 (YKST02 Monotherapy):
Participants will receive YKST02 as a single agent to evaluate its safety, tolerability, and preliminary efficacy.
Cohort 2 (Combination Therapy):
Participants will receive YKST02 in combination with YK012. This cohort includes a dose-escalation phase to evaluate safety and tolerability across dose levels, followed by a dose-expansion phase to further evaluate safety and preliminary efficacy at selected dose levels.
The study includes a screening period, a treatment period during which participants receive study drugs by intravenous infusion, and a follow-up period for safety and efficacy assessments.
Safety evaluations include monitoring of adverse events, clinical laboratory tests, and other safety parameters. PK and PD assessments will be performed to characterize drug exposure and biological activity. Immunogenicity will be evaluated by assessing anti-drug antibody responses.
Exploratory analyses may include evaluation of immune cell populations, cytokines, and other biomarkers to further characterize the biological effects of the study treatments.
- Conditions
- System Lupus Erythematosus(SLE)
- Being tested
- YKST02, YK012
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YKST02Drug
YKST02 is administered by intravenous (IV) infusion.
YK012Drug
YK012 is administered by intravenous (IV) infusion in combination with YKST02.
| Study group | Role | What they receive |
|---|---|---|
| YKST02 Monotherapy | Experimental | Participants receive YKST02 as monotherapy via intravenous (IV) infusion. Treatment includes induction doses followed by target dose administration. Receives: Drug: YKST02 |
| YKST02 + YK012 Combination Therapy | Experimental | Participants receive YKST02 in combination with YK012 via intravenous (IV) infusion. Treatment includes induction dosing followed by continued administration at protocol-defined dose levels. Receives: Drug: YKST02; Drug: YK012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
Number and proportion of participants experiencing dose-limiting toxicities (DLTs) as defined in the protocol.
Measured: From first dose through Day 35
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and proportion of participants experiencing adverse events (AEs) and serious adverse events (SAEs), graded according to CTCAE criteria.
Measured: From first dose up to Week 49
Secondary outcomes (19)
Pharmacokinetic (PK) Parameters
Pharmacokinetic parameters of study drug, including maximum observed concentration and overall exposure.
Measured: From first dose up to Week 49
Changes in Peripheral B Cell and T Cell Populations
Changes from baseline in peripheral blood B cells, T cells, and their subsets.
Measured: From baseline up to Week 49
Change from Baseline in Urinary Protein
Change from baseline in urinary protein (24-hour urine protein) in participants with baseline proteinuria (>0.5 g/24h).
Measured: From baseline up to Week 49
Change from Baseline in Anti-dsDNA Antibodies
Change from baseline in anti-double stranded DNA (anti-dsDNA) antibody levels.
Measured: From baseline up to Week 49
Change from Baseline in Complement Levels (C3 and C4)
Change from baseline in complement component C3 and C4 levels, analyzed and reported separately.
Measured: From baseline up to Week 49
Change from Baseline in Immunoglobulin Levels (IgG, IgM, IgA)
Change from baseline in immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels
Measured: From baseline up to Week 49
Incidence of Anti-Drug Antibodies (ADA)
Proportion of participants with treatment-emergent anti-drug antibodies (ADA); neutralizing antibodies may be assessed in ADA-positive participants.
Measured: From first dose up to Week 49
Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response Rate
Proportion of participants achieving a response defined by the Systemic Lupus Erythematosus Responder Index-4 (SRI-4), a composite responder endpoint based on improvement in disease activity as assessed by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), with no worsening in the British Isles Lupus Assessment Group 2004 index (BILAG-2004) and no clinically significant worsening in the Physician's Global Assessment (PGA).
Measured: Weeks 12, 24, and 48
British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response Rate
Proportion of participants achieving a response based on the British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA), a composite responder endpoint based on predefined criteria including improvement in disease activity as assessed by the BILAG-2004 index, no worsening in other organ systems, and no clinically significant worsening in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and Physician's Global Assessment (PGA).
Measured: Weeks 12, 24, and 48
Definitions Of Remission In Systemic Lupus Erythematosus (DORIS) Remission Rate
Proportion of participants achieving remission according to the Definitions Of Remission In Systemic Lupus Erythematosus (DORIS) criteria, based on predefined clinical criteria including absence of clinical disease activity and low Physician's Global Assessment (PGA), with stable background therapy.
Measured: Weeks 12, 24, and 48
Lupus Low Disease Activity State (LLDAS) Achievement Rate
Proportion of participants achieving low disease activity according to the Lupus Low Disease Activity State (LLDAS) criteria, based on predefined criteria including low overall disease activity, no new or worsening disease activity, and stable treatment.
Measured: Weeks 12, 24, and 48
Cutaneous Lupus Erythematosus Disease Area and Severity Index 50 (CLASI-50) Response Rate
Proportion of participants with at least 50% improvement from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score among participants with baseline CLASI score ≥10.
Measured: Up to Week 49
Joint Response Rate
Proportion of participants achieving improvement in joint counts.
Measured: From baseline up to Week 49
Glucocorticoid Dose Reduction
Proportion of participants achieving reduction to ≤5 mg/day prednisone (or equivalent).
Measured: Weeks 12, 24, and 48
Time to Disease Flare After Achieving LLDAS
Time from first achievement of LLDAS to disease flare.
Measured: Up to Week 49
Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Change from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, a validated composite measure of disease activity ranging from 0 to 105, where higher scores indicate greater disease activity.
Measured: From baseline up to Week 49
Change from Baseline in British Isles Lupus Assessment Group 2004 Index (BILAG-2004)
Change from baseline in disease activity as assessed by the British Isles Lupus Assessment Group 2004 Index (BILAG-2004), a validated organ-based disease activity index that categorizes disease severity across organ systems using ordinal grades (A, B, C, D, and E), where A represents the highest level of disease activity and E represents no current disease activity.
Measured: From baseline up to Week 49
Change from Baseline in Physician's Global Assessment (PGA)
Change from baseline in the Physician's Global Assessment (PGA) score, assessed using a 0 to 3 visual analogue scale, where higher scores indicate greater disease activity.
Measured: From baseline up to Week 49
Change from Baseline in Patient-Reported Outcomes (Quality of Life and Fatigue)
Change from baseline in patient-reported outcomes, including:
the 36-Item Short Form Health Survey (SF-36), a validated measure of health-related quality of life across multiple domains, with scores ranging from 0 to 100, where higher scores indicate better health status; the Fatigue Severity Scale (FSS), a validated measure of fatigue severity, with scores typically ranging from 1 to 7, where higher scores indicate greater fatigue.
Measured: From baseline up to Week 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study startMay 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for System Lupus Erythematosus(SLE)Studies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Qiubai Li, MD, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512947
- Sponsor's protocol ID
- YKST02-YK012-1
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of YKST02 as Monotherapy or in Combination With YK012 in Patients With Active or Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07512947
- Acronym / sponsor ID
- YKST02-YK012-1
- Conditions
- System Lupus Erythematosus(SLE)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 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.
The purpose of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YKST02 administered alone or in combination with YK012 in participants with active or refractory systemic lupus erythematosus (SLE).
The main questions this study aims to address are:
- Whether YKST02 alone or in combination with YK012 is safe and well tolerated in participants with active or refractory SLE
- Whether YKST02 alone or in combination with YK012 demonstrates preliminary efficacy in treating SLE
- What the PK and PD characteristics of YKST02 are when administered alone or in combination with YK012
- Whether treatment with YKST02 induces anti-drug antibody responses
Participants will:
- Receive intravenous infusions of YKST02 alone or in combination with YK012 according to the assigned cohort
- Undergo safety assessments, including monitoring for adverse events
- Provide blood samples for PK, PD, and immunogenicity analyses
- Be followed for approximately 49 weeks to assess safety and efficacy
Detailed description
This is a single-center, open-label clinical trial evaluating YKST02 administered alone or in combination with YK012 in participants with active or refractory systemic lupus erythematosus (SLE). The study is designed to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy.
The study consists of two cohorts:
Cohort 1 (YKST02 Monotherapy):
Participants will receive YKST02 as a single agent to evaluate its safety, tolerability, and preliminary efficacy.
Cohort 2 (Combination Therapy):
Participants will receive YKST02 in combination with YK012. This cohort includes a dose-escalation phase to evaluate safety and tolerability across dose levels, followed by a dose-expansion phase to further evaluate safety and preliminary efficacy at selected dose levels.
The study includes a screening period, a treatment period during which participants receive study drugs by intravenous infusion, and a follow-up period for safety and efficacy assessments.
Safety evaluations include monitoring of adverse events, clinical laboratory tests, and other safety parameters. PK and PD assessments will be performed to characterize drug exposure and biological activity. Immunogenicity will be evaluated by assessing anti-drug antibody responses.
Exploratory analyses may include evaluation of immune cell populations, cytokines, and other biomarkers to further characterize the biological effects of the study treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YKST02 Monotherapy | Experimental | Drug: YKST02Participants receive YKST02 as monotherapy via intravenous (IV) infusion. Treatment includes induction doses followed by target dose administration. |
| YKST02 + YK012 Combination Therapy | Experimental | Drug: YKST02, Drug: YK012Participants receive YKST02 in combination with YK012 via intravenous (IV) infusion. Treatment includes induction dosing followed by continued administration at protocol-defined dose levels. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria, with active disease defined as SLEDAI-2K ≥6 at screening, and considered to have inadequate response, intolerance, or ineligibility to standard therapy.
- Have received standard therapy for SLE for at least 12 weeks prior to screening (including corticosteroids and at least one immunosuppressant and/or biologic agent), or are intolerant to or unsuitable for such therapies.
- Receiving stable background therapy prior to enrollment, including stable doses of corticosteroids (within 2 weeks prior to enrollment), and/or antimalarial agents or one immunosuppressant (within 4 weeks prior to enrollment).
- Positive for at least one lupus-related autoantibody at screening (e.g., anti-dsDNA, antinuclear antibody, or anti-Smith antibody).
- Able and willing to provide written informed consent and comply with study procedures.
Key exclusion criteria (16 listed)
- Known hypersensitivity to monoclonal antibodies, immunoglobulins, or any component of the study drug.
- Prior treatment with B cell-depleting therapies, B cell-targeting biologics, or other biologic or targeted therapies within protocol-defined washout periods.
- Receipt of intravenous immunoglobulin or plasma exchange within protocol-defined washout periods.
- Receipt of live or attenuated vaccines within 4 weeks prior to enrollment.
- Presence of other active autoimmune diseases or inflammatory conditions (except secondary Sjögren's syndrome) that may interfere with assessment of SLE disease activity.
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 |
|---|---|---|
| YKST02YKST02 is administered by intravenous (IV) infusion. | Drug | YKST02 + YK012 Combination Therapy, YKST02 Monotherapy |
| YK012YK012 is administered by intravenous (IV) infusion in combination with YKST02. | Drug | YKST02 + YK012 Combination Therapy |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: From first dose through Day 35
Number and proportion of participants experiencing dose-limiting toxicities (DLTs) as defined in the protocol.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose up to Week 49
Number and proportion of participants experiencing adverse events (AEs) and serious adverse events (SAEs), graded according to CTCAE criteria.
19 secondary outcomes
Pharmacokinetic (PK) Parameters
Time frame: From first dose up to Week 49
Changes in Peripheral B Cell and T Cell Populations
Time frame: From baseline up to Week 49
Change from Baseline in Urinary Protein
Time frame: From baseline up to Week 49
Change from Baseline in Anti-dsDNA Antibodies
Time frame: From baseline up to Week 49
Change from Baseline in Complement Levels (C3 and C4)
Time frame: From baseline up to Week 49
Change from Baseline in Immunoglobulin Levels (IgG, IgM, IgA)
Time frame: From baseline up to Week 49
Incidence of Anti-Drug Antibodies (ADA)
Time frame: From first dose up to Week 49
Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response Rate
Time frame: Weeks 12, 24, and 48
British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response Rate
Time frame: Weeks 12, 24, and 48
Definitions Of Remission In Systemic Lupus Erythematosus (DORIS) Remission Rate
Time frame: Weeks 12, 24, and 48
Lupus Low Disease Activity State (LLDAS) Achievement Rate
Time frame: Weeks 12, 24, and 48
Cutaneous Lupus Erythematosus Disease Area and Severity Index 50 (CLASI-50) Response Rate
Time frame: Up to Week 49
Joint Response Rate
Time frame: From baseline up to Week 49
Glucocorticoid Dose Reduction
Time frame: Weeks 12, 24, and 48
Time to Disease Flare After Achieving LLDAS
Time frame: Up to Week 49
Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Time frame: From baseline up to Week 49
Change from Baseline in British Isles Lupus Assessment Group 2004 Index (BILAG-2004)
Time frame: From baseline up to Week 49
Change from Baseline in Physician's Global Assessment (PGA)
Time frame: From baseline up to Week 49
Change from Baseline in Patient-Reported Outcomes (Quality of Life and Fatigue)
Time frame: From baseline up to Week 49
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 6 Apr 2026.
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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.
Qiubai Li, MD, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YKST02 and YK012 in people with System Lupus Erythematosus(SLE), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 5 inclusion and 16 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 6 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 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.
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 Qiubai Li, MD, PhD (+86 27 85726338, qiubaili@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: From first dose through Day 35). The study lists 2 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 6 Apr 2026.