Systemic Lupus Erythematosus (SLE)Phase 1NCT07444307
A Clinical Study of Dual-Target, Universal CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
A Phase 1 study testing QT-019B Cell Injection in people with Systemic Lupus Erythematosus (SLE), run by Hangzhou Qihan Biotech Co., Ltd. at 3 sites in China.
Trial summary
This study is a single-arm, open-label clinical study designed to evaluate the safety and tolerability of QT-019B in subjects with refractory SLE and to determine the RD. The study has two phases: dose escalation and dose expansion, with a planned enrollment of 18-24 subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- QT-019B Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesChina
- Study dates
- 15 Dec 2025to 31 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥18 years and ≤65 years at screening, gender is not limited.
- 2. Subjects diagnosed with systemic lupus erythematosus according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria.
- 3. Meets the criteria for refractory SLE: a) Must have received adequate standard treatment prior to screening, including glucocorticoids, immunosuppressants, biologics. b) Refractory SLE is defined as a failure to respond, or a documented adverse event or intolerance to glucocorticoids combined with other immunosuppressive therapies. The patient should have had received treatment with courses of at least two different non glucocorticoid immunosuppressive therapies (not necessarily simultaneously), at least one of which is a B cell-depleting biological agent such as belimumab, rituximab (unless such drugs are deemed contraindicated by the investigator or such drugs are not readily available to the patient).
- 4. Positive serological test during the screening period, for at least one of the following autoantibodies: antinuclear antibodies (ANA) at a titer of ≥1:80, or anti dsDNA (above the ULN), or anti-Sm (above the ULN), or other disease related autoantibodies (abovethe ULN).
- 5. At screening: a) SLE with or without Lupus Nephritis with SLEDAI-2K≥6. b) Severe, refractory SLE-ITP which is characterized by platelet count < 30×109/L, or < 50×109/L accompanied by a bleeding tendency.
- 6. Important organ functions during the screening period must meet the following requirements (excluding abnormalities related to SLE): a) Bone marrow function must meet the following: a. Neutrophil count ≥0.5×109/L; b. Hemoglobin ≥ 60g/L. b) Liver function: Alanine aminotransferase (ALT) ≤ 2×ULN, Aspartate aminotransferase (AST) ≤ 2×ULN, Total bilirubin (TBil) ≤ 2×ULN. c) Renal function: Creatinine clearance (CrCl) ≥ 30 ml/min (Cockcroft/Gault formula).
- 7. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must use medically approved contraceptive measures or abstain from sex during the study treatment period and for at least 12 months after the end of the study treatment; female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding.
- 8. Voluntarily participate in this clinical study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Who cannot join
- 1. Presence or definite history of central nervous system disorders, such as seizures, epilepsy, cerebrovascular accident (ischemic/hemorrhagic), cerebral edema, paralysis, aphasia, severe brain injury, dementia, Parkinson's disease, cerebellar disease, encephalitis, central nervous system vasculitis, or mental illness. If epilepsy caused by lupus is stable without seizures for 1 year before screening, screening may be performed.
- 2. Need for hemodialysis or high-dose corticosteroid therapy (prednisone ≥1.5 mg/kg/day or equivalent corticosteroid therapy ≥14 days) within 2 months before screening.
- 3. A large amount of serous cavity effusion with compressive symptoms that cannot be controlled after treatment (such as pleural effusion, ascites).
- 4. In the two years prior to the screening, subjects with other active autoimmune diseases (such as Crohn's disease or rheumatoid arthritis), except for SLE and its related conditions (such as SLE-induced thrombocytopenic purpura or SLE-associated autoimmune hemolytic anemia), as well as autoimmune thyroid disease and secondary Sjögren's disease.
- 5. Hematopoietic dysfunction that does not fulfill the criteria for SLE and its related ITP as determined by a bone marrow aspirate and/or biopsy, or subjects who have received or are waiting for hematopoietic stem cell/bone marrow transplantation or organ transplantation.
- 6. Subjects who have previously received gene-modified cell therapy, such as TCR-T, CAR-T, CAR-NK cells, and others.
Show all 13Show fewer
- 7. Subjects who have used any other investigational drug for SLE within 4 weeks prior to screening.
- 8. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer above the upper limit of detection, subjects with positive hepatitis C virus (HCV) antibody and positive peripheral blood HCV RNA, subjects with positive human immunodeficiency virus (HIV) antibody, subjects with positive syphilis test.
- 9. Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg) within one month prior to screening, or any other serious cardiovascular diseases that could present potentially significant risks for participation in the study. Any of the following cardiovascular disease history within 6 months prior to screening: QTc prolongation syndrome or QTc interval >480 ms, complete left bundle branch block, second/third degree atrioventricular block, severe uncontrolled arrhythmia requiring medication, history of chronic congestive heart failure within 6 months prior to screening, NYHA≥3, cardiac ejection fraction <45%, myocardial infarction, cardiac angioplasty or stent implantation, unstable angina, severe pericardial disease, or other clinically significant heart disease within 6 months prior to screening.
- 10. A documented history of symptomatic deep vein thrombosis or pulmonary embolism within six months prior to the screening, or the presence of clinically significant pleural effusion, or an oxygen saturation level below 92% while breathing ambient air.
- 11. History of treated or untreated malignancy of any organ system within 5 years prior to screening (excluding basal cell carcinoma of the skin, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, follicular or papillary thyroid cancer, and other tumors with good prognosis).
- 12. Participants with any active infection, and any infection requiring systemic antimicrobial therapy within the past 30 days.
- 13. Any additional factors that the investigator thinks could put the subjects at risk, affect their adherence to treatment, disrupt the study's execution, or influence the study results.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Mengtao Li, PhD, +86 10 6915 1188, mengtao.li@cstar.org.cn
- Recruiting
The First Affiliated Hospital of Ustc Anhui Provincial Hospital
Hefei, Anhui
Zhu Chen, PhD, 0551-62283114, doczchen@ustc.edu.cn
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Qiubai Li, PhD, 027-85726375, qiubaili@hust.edu.cn
About this study
Official title: A Phase I/IIa Clinical Study to Evaluate Universal Allogeneic CAR-T Cells (QT-019B) Targeting CD19 and BCMA for the Treatment of Refractory Systemic Lupus Erythematosus
This study is a single-arm, open-label clinical study designed to evaluate the safety and tolerability of QT-019B in subjects with refractory SLE and to determine the RD. The study has two phases: dose escalation and dose expansion, with a planned enrollment of 18-24 subjects.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- QT-019B Cell Injection
- Keywords
- Refractory Systemic Lupus Erythematosus, Universal Allogeneic CAR-T Cells
- 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.
QT-019B Cell InjectionDrug
The study will begin by enrolling the first subject in Dose A (1×106/kg), followed by a 14-day interval before enrolling the following subjects at this dose level.
Upon completing the DLT observation period for Dose Group A: 1) if no DLTs are observed, the SRC may choose to proceed to Dose Group B (3×106/kg). 2) if one DLT is noted, the SRC may opt to add 3 more subjects to Dose A, and if a second DLT occurs, the SRC may consider ending the study or reducing the dose. 3) if two DLTs are observed at Dose A, the SRC may decide to terminate the study or reduce the dose.
| Study group | Role | What they receive |
|---|---|---|
| QT-019B Cell Injection | Experimental | The study will begin by enrolling the first subject in Dose A (1×106/kg), followed by a 14-day interval before enrolling the following subjects at this dose level.
Upon completing the DLT observation period for Dose Group A: 1) if no DLTs are observed, the SRC may choose to proceed to Dose Group B (3×106/kg). 2) if one DLT is noted, the SRC may opt to add 3 more subjects to Dose A, and if a second DLT occurs, the SRC may consider ending the study or reducing the dose. 3) if two DLTs are observed at Dose A, the SRC may decide to terminate the study or reduce the dose. Receives: Drug: QT-019B Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Dose-Limiting Toxicities (DLTs)
A Dose-Limiting Toxicity (DLT) is defined as a specific set of severe (Grade 3 or higher) treatment-related toxicities (including hematological and non-hematological toxicities) that occur during the DLT observation period. DLTs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. This measure is used to determine the Recommended Dose (RD).
Measured: Within 28 days following QT-019B administration.
Number of Subjects with Adverse Events (AEs)
This includes the frequency and severity of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs). Severity will be assessed using NCI-CTCAE v5.0. This includes systemic toxicities and cell-therapy-specific events such as Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
Measured: From QT-019B administration through Day 28 (Acute Safety Period).
Secondary outcomes (6)
Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) Score.
The Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) is a validated clinical instrument used to assess disease activity in SLE. The scale ranges from a minimum score of 0 to a maximum score of 105. Higher scores indicate a worse outcome (greater disease activity).
Measured: Day 28, 60, 90, 180, 270, 360, 450, 540, 630, and 730.
Change from Baseline in Physician's Global Assessment (PGA) Score
The Physician Global Assessment (PGA) is a visual analog scale used by the investigator to rate the patient's overall disease activity. The scale ranges from a minimum of 0 (no disease activity) to a maximum of 3 (severe disease activity). Higher scores indicate a worse outcome.
Measured: Day 28, 60, 90, 180, 270, 360, 450, 540, 630, and 730.
Change from Baseline in British Isles Lupus Assessment Group 2004 (BILAG-2004) Index.
The British Isles Lupus Assessment Group 2004 (BILAG-2004) index measures disease activity across 9 organ systems. For the purpose of numerical analysis, category scores (A-E) are often converted to a total numerical score. The scale ranges from a minimum of 0 to a maximum of 72. Higher scores indicate a worse outcome (higher disease activity).
Measured: Day 28, 60, 90, 180, 270, 360, 450, 540, 630, and 730
Peak Concentration (Cmax) of QT-019B in Peripheral Blood
The maximum observed concentration of QT-019B (CAR-transgene copies) in peripheral blood measured via qPCR/ddPCR after administration. This represents the peak expansion of the cell product.
Measured: From Day 0 through Day 28 post-administration.
Area Under the Concentration-Time Curve (AUC 0-28d) of QT-019B
The total systemic exposure of QT-019B in peripheral blood over the first 28 days post-infusion, calculated using the linear trapezoidal rule.
Measured: From Day 0 through Day 28 post-administration.
Time to Reach Peak Concentration (Tmax) of QT-019B
The time (in days) from the start of QT-019B infusion to the observation of the maximum concentration (Cmax) in peripheral blood.
Measured: From Day 0 through Day 28 post-administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start15 Dec 2025
- Primary completion31 Dec 2028 (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 Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Qihan Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mengtao Li, PhD, Principal investigator, Peking Union Medical College HospitalZhu Chen, PhD, Principal investigator, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)Qiubai Li, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyTing Zhang, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444307
- Sponsor's protocol ID
- QT-019B-001CN
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Clinical Study to Evaluate Universal Allogeneic CAR-T Cells (QT-019B) Targeting CD19 and BCMA for the Treatment of Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07444307
- Acronym / sponsor ID
- QT-019B-001CN
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- Refractory Systemic Lupus Erythematosus, Universal Allogeneic CAR-T Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hangzhou Qihan Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Mar 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 study is a single-arm, open-label clinical study designed to evaluate the safety and tolerability of QT-019B in subjects with refractory SLE and to determine the RD. The study has two phases: dose escalation and dose expansion, with a planned enrollment of 18-24 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QT-019B Cell Injection | Experimental | Drug: QT-019B Cell InjectionThe study will begin by enrolling the first subject in Dose A (1×106/kg), followed by a 14-day interval before enrolling the following subjects at this dose level. Upon completing the DLT observation period for Dose Group A: 1) if no DLTs are observed, the SRC may choose to proceed to Dose Group B (3×106/kg). 2) if one DLT is noted, the SRC may opt to add 3 more subjects to Dose A, and if a second DLT occurs, the SRC may consider ending the study or reducing the dose. 3) if two DLTs are observed at Dose A, the SRC may decide to terminate the study or reduce the dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Age ≥18 years and ≤65 years at screening, gender is not limited.
- 2. Subjects diagnosed with systemic lupus erythematosus according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria.
- 3. Meets the criteria for refractory SLE: a) Must have received adequate standard treatment prior to screening, including glucocorticoids, immunosuppressants, biologics. b) Refractory SLE is defined as a failure to respond, or a documented adverse event or intolerance to glucocorticoids combined with other immunosuppressive therapies. The patient should have had received treatment with courses of at least two different non glucocorticoid immunosuppressive therapies (not necessarily simultaneously), at least one of which is a B cell-depleting biological agent such as belimumab, rituximab (unless such drugs are deemed contraindicated by the investigator or such drugs are not readily available to the patient).
- 4. Positive serological test during the screening period, for at least one of the following autoantibodies: antinuclear antibodies (ANA) at a titer of ≥1:80, or anti dsDNA (above the ULN), or anti-Sm (above the ULN), or other disease related autoantibodies (abovethe ULN).
- 5. At screening: a) SLE with or without Lupus Nephritis with SLEDAI-2K≥6. b) Severe, refractory SLE-ITP which is characterized by platelet count < 30×109/L, or < 50×109/L accompanied by a bleeding tendency.
Key exclusion criteria (13 listed)
- 1. Presence or definite history of central nervous system disorders, such as seizures, epilepsy, cerebrovascular accident (ischemic/hemorrhagic), cerebral edema, paralysis, aphasia, severe brain injury, dementia, Parkinson's disease, cerebellar disease, encephalitis, central nervous system vasculitis, or mental illness. If epilepsy caused by lupus is stable without seizures for 1 year before screening, screening may be performed.
- 2. Need for hemodialysis or high-dose corticosteroid therapy (prednisone ≥1.5 mg/kg/day or equivalent corticosteroid therapy ≥14 days) within 2 months before screening.
- 3. A large amount of serous cavity effusion with compressive symptoms that cannot be controlled after treatment (such as pleural effusion, ascites).
- 4. In the two years prior to the screening, subjects with other active autoimmune diseases (such as Crohn's disease or rheumatoid arthritis), except for SLE and its related conditions (such as SLE-induced thrombocytopenic purpura or SLE-associated autoimmune hemolytic anemia), as well as autoimmune thyroid disease and secondary Sjögren's disease.
- 5. Hematopoietic dysfunction that does not fulfill the criteria for SLE and its related ITP as determined by a bone marrow aspirate and/or biopsy, or subjects who have received or are waiting for hematopoietic stem cell/bone marrow transplantation or organ transplantation.
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 |
|---|---|---|
| QT-019B Cell InjectionThe study will begin by enrolling the first subject in Dose A (1×106/kg), followed by a 14-day interval before enrolling the following subjects at this dose level. Upon completing the DLT observation period for Dose Group A: 1) if no DLTs are observed, the SRC may choose to proceed to Dose Group B (3×106/kg). 2) if one DLT is noted, the SRC may opt to add 3 more subjects to Dose A, and if a second DLT occurs, the SRC may consider ending the study or reducing the dose. 3) if two DLTs are observed at Dose A, the SRC may decide to terminate the study or reduce the dose. | Drug | QT-019B Cell Injection |
Primary outcome
Number of Subjects With Dose-Limiting Toxicities (DLTs)
Time frame: Within 28 days following QT-019B administration.
A Dose-Limiting Toxicity (DLT) is defined as a specific set of severe (Grade 3 or higher) treatment-related toxicities (including hematological and non-hematological toxicities) that occur during the DLT observation period. DLTs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. This measure is used to determine the Recommended Dose (RD).
Number of Subjects with Adverse Events (AEs)
Time frame: From QT-019B administration through Day 28 (Acute Safety Period).
This includes the frequency and severity of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs). Severity will be assessed using NCI-CTCAE v5.0. This includes systemic toxicities and cell-therapy-specific events such as Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
6 secondary outcomes
Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) Score.
Time frame: Day 28, 60, 90, 180, 270, 360, 450, 540, 630, and 730.
Change from Baseline in Physician's Global Assessment (PGA) Score
Time frame: Day 28, 60, 90, 180, 270, 360, 450, 540, 630, and 730.
Change from Baseline in British Isles Lupus Assessment Group 2004 (BILAG-2004) Index.
Time frame: Day 28, 60, 90, 180, 270, 360, 450, 540, 630, and 730
Peak Concentration (Cmax) of QT-019B in Peripheral Blood
Time frame: From Day 0 through Day 28 post-administration.
Area Under the Concentration-Time Curve (AUC 0-28d) of QT-019B
Time frame: From Day 0 through Day 28 post-administration.
Time to Reach Peak Concentration (Tmax) of QT-019B
Time frame: From Day 0 through Day 28 post-administration.
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 2 Mar 2026.
- 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.
Mengtao Li, PhD principal investigator
Peking Union Medical College Hospital
Zhu Chen, PhD principal investigator
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Qiubai Li, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QT-019B Cell Injection in people with Systemic Lupus Erythematosus (SLE), run by Hangzhou Qihan Biotech Co., Ltd. at 3 sites 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 8 inclusion and 13 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Zhijiang Wang (+86 151 5712 6379, zhijiang.wang@qihanbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Dose-Limiting Toxicities (DLTs) (time frame: Within 28 days following QT-019B administration.). 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 2 Mar 2026.