Autoimmune DiseasesEarly Phase 1NCT07604792
FIT-(BCMA+CD19)-CAR-T Cells in Recurrent/Refractory Autoimmune Diseases Patients.
A Early Phase 1 study testing FIT-(BCMA+CD19)-CAR-T Cells in people with Autoimmune Diseases, run by Beijing Boren Hospital at 1 site in China.
Trial summary
This study is a single-center, open-label, single-dose exploration clinical trial for treating patients with partially relapsed/refractory autoimmune diseases by infusing FIT-(BCMA+CD19)-CAR-T cells after pre-treatment with cleansing therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- FIT-(BCMA+CD19)-CAR-T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 30 Apr 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in the clinical study, with the subject or their legally authorized representative fully understanding and providing written informed consent (ICF) for this study, and willingness to comply with and complete all trial procedures.
- Aged 18 to 70 years.
- ECOG performance status ≤ 2.
- Life expectancy of at least 12 weeks.
- Adequate venous access for apheresis and no other contraindications to blood cell separation.
- Laboratory parameters at screening must meet the following requirements, with no receipt of cell growth factors within 7 days (or 2 weeks for long-acting formulations) prior to the screening hematology assessment:
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- Absolute neutrophil count ≥ 1.0 × 10⁹/L. Hemoglobin ≥ 60 g/L (without red blood cell transfusion within 14 days). Platelet count ≥ 50 × 10⁹/L (thrombocytopenia due to autoimmune disease may be excluded at the investigator's discretion).
- Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (acute elevations due to autoimmune disease may be excluded at the investigator's discretion).
- Creatinine clearance (Cockcroft-Gault formula) ≥ 30 mL/min.
- Cardiac ejection fraction ≥ 45%, no pericardial effusion (excluding minimal or physiological effusion) confirmed by echocardiography (ECHO), and no clinically significant findings on electrocardiogram (ECG).
- Baseline oxygen saturation > 92% while breathing room air.
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential).
- Male and female subjects willing to practice contraception from the time of signing the ICF until 12 months after the last dose of study drug.
Who cannot join
- Active central nervous system (CNS) disease, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
- Presence or suspicion of fungal, bacterial (including but not limited to Mycobacterium tuberculosis), viral, or other infection that is uncontrolled or requires intravenous antifungal, antibacterial, or antiviral therapy; uncomplicated urinary tract infection and uncomplicated bacterial pharyngitis are permitted.
- Hepatitis B (positive for hepatitis B surface antigen [HBsAg] with HBV DNA > 1000 copies/mL), hepatitis C (positive for hepatitis C antibody), syphilis infection (positive for antibody), or human immunodeficiency virus (HIV) infection.
- Prior or concomitant medication:
- Prior use of any CAR-T cell product or other genetically modified T-cell therapy.
- History of CD19-targeted therapy. Receipt of live vaccine within 4 weeks before enrollment. Use of another investigational medicinal product within 30 days before screening.
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- Receipt of biologic macromolecular drugs (e.g., rituximab, belimumab, telitacicept, adalimumab, etanercept, etc.) that have therapeutic effects on the target indication within 4 weeks or 5 half-lives before enrollment.
- Receipt of > 20 mg/day of prednisone or equivalent doses of other corticosteroids within 2 weeks before enrollment.
- Receipt of conventional synthetic disease-modifying drugs (e.g., cyclophosphamide, methotrexate, leflunomide, sulfasalazine, etc.) that have therapeutic effects on the target indication within 2 weeks before enrollment.
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months before enrollment.
- History of genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Kostmann syndrome, Schwachman-Diamond syndrome, etc.
- History of lymphoproliferative disease or malignancy (except for basal cell carcinoma of the skin, in situ carcinoma of the breast/cervix, and other diseases that are disease-free and have not been treated within the past five years).
- Women of childbearing potential who are pregnant or breastfeeding.
- Any medical activity that may interfere with the evaluation of study safety or efficacy.
- In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up, or to comply with the requirements for study participation.
- Specific Inclusion/Exclusion Criteria
- Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
- Meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE.
- Disease activity score (SLEDAI-2000) ≥ 6 and at least one British Isles Lupus Assessment Group (BILAG-2004) category A (severe manifestation) or two category B (moderate manifestation) organ scores, or both; OR SLEDAI-2000 ≥ 8.
- Definition of relapsed/refractory: persistent disease activity despite conventional therapy for more than 6 months, or recurrence of disease activity after remission. Conventional therapy is defined as the use of corticosteroids and cyclophosphamide, plus any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.
- Relapsed/Refractory Sjögren's Syndrome
- Meet the 2002 AECG criteria or the 2016 ACR/EULAR classification criteria for primary Sjögren's syndrome.
- Disease activity score (ESSDAI) ≥ 6.
- Positive anti-SSA/Ro antibody.
- Definition of relapsed/refractory: persistent disease activity despite conventional therapy for more than 6 months, or recurrence of disease activity after remission. Conventional therapy is defined as the use of corticosteroids and cyclophosphamide, plus any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.
- Relapsed/Refractory/Progressive Diffuse Scleroderma
- Meet the 2013 ACR classification criteria for scleroderma.
- Positive scleroderma-associated antibodies.
- Diffuse cutaneous sclerosis manifestations or active interstitial lung disease (ground-glass opacities on HRCT).
- Definition of relapsed/refractory: persistent disease activity despite conventional therapy for more than 6 months, or recurrence of disease activity after remission. Conventional therapy is defined as the use of corticosteroids and cyclophosphamide, plus any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.
- Definition of progressive: rapid skin progression (increase in mRSS > 25%); or progression of lung disease (FVC reduction ≥ 10%, or FVC reduction > 5% accompanied by DLCO reduction ≥ 15%).
- Note: Fulfillment of either criterion 4 or criterion 5 is sufficient.
- Relapsed/Refractory/Progressive Inflammatory Myopathy
- Meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (including DM, PM, ASS, and NM).
- Positive myositis antibodies.
- For patients with muscle involvement: MMT-8 score < 142 and at least two of the following five core set measures are abnormal (PhGA, PtGA, or extra-muscular disease activity score ≥ 2; total HAQ score ≥ 0.25; muscle enzyme levels ≥ 1.5 times the upper limit of normal); OR MMT-8 score ≥ 142 but with active interstitial lung disease (ground-glass opacities on HRCT).
- Definition of relapsed/refractory: persistent disease activity despite conventional therapy for more than 6 months, or recurrence of disease activity after remission. Conventional therapy is defined as the use of corticosteroids and cyclophosphamide, plus any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.
- Definition of progressive: rapidly progressive interstitial pneumonia within a short period of time.
- Note: Fulfillment of either criterion 4 or criterion 5 is sufficient.
- Relapsed/Refractory ANCA-Associated Vasculitis
- Meet the 2022 ACR/EULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.
- Positive ANCA-associated antibodies (MPO-ANCA or PR3-ANCA positive).
- Birmingham Vasculitis Activity Score (BVAS) ≥ 15 (total score 63), indicating active vasculitis.
- BVAS assessment must include at least one major item, at least three minor items, or at least two renal items (hematuria and proteinuria).
- Definition of relapsed/refractory: persistent disease activity despite conventional therapy for more than 6 months, or recurrence of disease activity after remission. Conventional therapy is defined as the use of corticosteroids and cyclophosphamide, plus any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.
- Relapsed/Refractory/Catastrophic Antiphospholipid Syndrome
- Meet the 2006 Sydney revised diagnostic criteria for primary antiphospholipid syndrome.
- Positive medium-to-high titer antiphospholipid antibodies (IgG/IgM of LA, β2GP1, or aCL), with positivity detected more than twice within 12 weeks.
- Definition of relapsed/refractory: recurrent thrombosis despite standard treatment with warfarin or alternative vitamin K antagonists (i.e., INR within therapeutic range) or standard therapeutic dose low molecular weight heparin (LMWH), and prior use of corticosteroids and cyclophosphamide.
- Catastrophic antiphospholipid syndrome must meet all four of the following criteria: (1) involvement of three or more organs, systems, and/or tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) positive aPL.
- Note: Fulfillment of either criterion 3 or criterion 4 is sufficient.
- Relapsed/Refractory Autoimmune Hemolytic Anemia
- Meet the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Autoimmune Hemolytic Anemia in Adults (2023 Edition).
- Hemoglobin level meeting the criteria for anemia; (ii) decreased serum haptoglobin (< 250 mg/L), elevated total bilirubin (≥ 17.1 μmol/L, predominantly unconjugated bilirubin), elevated lactate dehydrogenase, and reticulocyte percentage > 4% or absolute reticulocyte count > 120 × 10⁹/L; (iii) detection of red blood cell autoantibodies.
- Definition of relapsed/refractory: failure, intolerance, or contraindication to at least 3 months of therapy with corticosteroids in combination with at least one immunosuppressant (cyclophosphamide, azathioprine, vinca alkaloids, calcineurin inhibitors, mycophenolate mofetil) and/or rituximab (second-line therapy for patients with corticosteroid resistance, relapse, intolerance, dependence, or contraindications: rituximab), with persistent anemia and hemolytic symptoms of varying degrees, and laboratory findings not meeting partial remission criteria (HGB increase > 20 g/L, or HGB normalized but hemolytic biochemical parameters not fully normalized [including reticulocytes, haptoglobin, bilirubin, and lactate dehydrogenase], and transfusion-free for at least 7 days); OR achievement of complete remission (disappearance of clinical symptoms, normalization of red blood cell count, hemoglobin level, reticulocyte percentage, serum bilirubin level, and negative direct and indirect Coombs test) after the above therapy but relapse during maintenance therapy or after drug discontinuation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Clinical Study Evaluating the Safety and Efficacy of Infusing the Non-virally Prepared BCMA/CD19 Bispecific CAR-T Cell Injection in Patients With Partially Relapsed/Refractory Autoimmune Diseases.
This study is a single-center, open-label, single-dose exploration clinical trial for treating patients with partially relapsed/refractory autoimmune diseases by infusing FIT-(BCMA+CD19)-CAR-T cells after pre-treatment with cleansing therapy.
In this study phase, a traditional "3+3" trial design is employed for dose escalation.
Read the detailed description
This study intends to include some patients with relapsed/refractory autoimmune diseases. The subjects will undergo single infusion of FIT-(BCMA+CD19)-CAR-T cells after undergoing screening, collection of peripheral blood mononuclear cells (PBMC), and pre-treatment with conditioning chemotherapy. Apart from the baseline period, the time points for evaluating the therapeutic efficacy of the subjects after treatment are the 1st、2nd、3rd、6th、9th and 12th month after infusion, until disease progression (PD), relapse, change of treatment regimen, death, intolerable toxicity, at the discretion of the investigator, or voluntary withdrawal by the patient (whichever occurs first).
Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Safety of FIT-(BCMA+CD19)-CAR-T cell therapy will be evaluated through laboratory tests, 12-lead electrocardiograms, vital signs, physical examinations, etc. Blood samples will be collected from subjects to assess cellular pharmacokinetics and explore the effects of cellular drugs on ferritin, C-reactive protein, and related cytokines.
- Conditions
- Autoimmune Diseases
- Being tested
- FIT-(BCMA+CD19)-CAR-T Cells
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT-(BCMA+CD19)-CAR-T CellsBiological
Before cell infusion, researchers may decide, based on necessity, whether to administer prophylactic medication, which may include options such as acetaminophen and diphenhydramine, or H1 antihistamines, among others. Subjects are allowed to receive adequate supportive care after FIT-(BCMA+CD19)-CAR-T cells infusion, including blood transfusions and blood products, antibiotic therapy, antiemetics, antidiarrheals, analgesics, etc.
| Study group | Role | What they receive |
|---|---|---|
| FIT-(BCMA+CD19)-CAR-T Cells | Experimental | FIT-(BCMA+CD19)-CAR-T cells infusion. Infusion doses: The planned infusion doses are as follows: the first dose group at 1×10^5 cells/kg; the second dose group at 3×10^5 cells/kg; the third dose group at 1×10^6 cells/ kg. Infusion doses refer to the number of CAR-positive cells. Receives: Biological: FIT-(BCMA+CD19)-CAR-T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity
The proportion of patients receiving CAR-T cells who encounter dose-limiting toxicities (DLTs). Safety evaluations are performed in accordance with the NCI-CTCAE version 5.0 standards (Cytokine Release Syndrome and neurotoxicity will be graded based on ASTCT/ASBMT grading criteria).
Measured: Up to 28 days from CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start25 Sep 2025
- Primary completion7 Nov 2025
- Study completion30 Apr 2026
Why it stopped: No participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Boren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604792
- Sponsor's protocol ID
- BCMA/CD19-CN-A1
- Status last verified
- Oct 2026
- First submitted
- 17 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study Evaluating the Safety and Efficacy of Infusing the Non-virally Prepared BCMA/CD19 Bispecific CAR-T Cell Injection in Patients With Partially Relapsed/Refractory Autoimmune Diseases.
- ClinicalTrials.gov ID
- NCT07604792
- Acronym / sponsor ID
- BCMA/CD19-CN-A1
- Conditions
- Autoimmune Diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beijing Boren HospitalUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 22 May 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-center, open-label, single-dose exploration clinical trial for treating patients with partially relapsed/refractory autoimmune diseases by infusing FIT-(BCMA+CD19)-CAR-T cells after pre-treatment with cleansing therapy.
In this study phase, a traditional "3+3" trial design is employed for dose escalation.
Detailed description
This study intends to include some patients with relapsed/refractory autoimmune diseases. The subjects will undergo single infusion of FIT-(BCMA+CD19)-CAR-T cells after undergoing screening, collection of peripheral blood mononuclear cells (PBMC), and pre-treatment with conditioning chemotherapy. Apart from the baseline period, the time points for evaluating the therapeutic efficacy of the subjects after treatment are the 1st、2nd、3rd、6th、9th and 12th month after infusion, until disease progression (PD), relapse, change of treatment regimen, death, intolerable toxicity, at the discretion of the investigator, or voluntary withdrawal by the patient (whichever occurs first).
Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Safety of FIT-(BCMA+CD19)-CAR-T cell therapy will be evaluated through laboratory tests, 12-lead electrocardiograms, vital signs, physical examinations, etc. Blood samples will be collected from subjects to assess cellular pharmacokinetics and explore the effects of cellular drugs on ferritin, C-reactive protein, and related cytokines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIT-(BCMA+CD19)-CAR-T Cells | Experimental | Biological: FIT-(BCMA+CD19)-CAR-T CellsFIT-(BCMA+CD19)-CAR-T cells infusion. Infusion doses: The planned infusion doses are as follows: the first dose group at 1×10^5 cells/kg; the second dose group at 3×10^5 cells/kg; the third dose group at 1×10^6 cells/ kg. Infusion doses refer to the number of CAR-positive cells. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntary participation in the clinical study, with the subject or their legally authorized representative fully understanding and providing written informed consent (ICF) for this study, and willingness to comply with and complete all trial procedures.
- Aged 18 to 70 years.
- ECOG performance status ≤ 2.
- Life expectancy of at least 12 weeks.
- Adequate venous access for apheresis and no other contraindications to blood cell separation.
Key exclusion criteria (55 listed)
- Active central nervous system (CNS) disease, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
- Presence or suspicion of fungal, bacterial (including but not limited to Mycobacterium tuberculosis), viral, or other infection that is uncontrolled or requires intravenous antifungal, antibacterial, or antiviral therapy; uncomplicated urinary tract infection and uncomplicated bacterial pharyngitis are permitted.
- Hepatitis B (positive for hepatitis B surface antigen [HBsAg] with HBV DNA > 1000 copies/mL), hepatitis C (positive for hepatitis C antibody), syphilis infection (positive for antibody), or human immunodeficiency virus (HIV) infection.
- Prior or concomitant medication:
- Prior use of any CAR-T cell product or other genetically modified T-cell therapy.
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 |
|---|---|---|
| FIT-(BCMA+CD19)-CAR-T CellsBefore cell infusion, researchers may decide, based on necessity, whether to administer prophylactic medication, which may include options such as acetaminophen and diphenhydramine, or H1 antihistamines, among others. Subjects are allowed to receive adequate supportive care after FIT-(BCMA+CD19)-CAR-T cells infusion, including blood transfusions and blood products, antibiotic therapy, antiemetics, antidiarrheals, analgesics, etc. | Biological | FIT-(BCMA+CD19)-CAR-T Cells |
Primary outcome
Incidence of dose-limiting toxicity
Time frame: Up to 28 days from CAR-T infusion
The proportion of patients receiving CAR-T cells who encounter dose-limiting toxicities (DLTs). Safety evaluations are performed in accordance with the NCI-CTCAE version 5.0 standards (Cytokine Release Syndrome and neurotoxicity will be graded based on ASTCT/ASBMT grading criteria).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing FIT-(BCMA+CD19)-CAR-T Cells in people with Autoimmune Diseases, run by Beijing Boren Hospital 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 13 inclusion and 55 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: withdrawn, as of the sponsor's last update on 15 Oct 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (time frame: Up to 28 days from CAR-T infusion). 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 15 Oct 2026.