Autoimmune DiseasesSCAR02NCT06503224
An Exploratory Clinical Study of SCAR02 Targeting BCMA and CD19 for the Treatment of Refractory Autoimmune Diseases
A study testing Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis. in people with Autoimmune Diseases, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
Trial summary
This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2024to 30 Apr 2028
- Phase
- Interventional
- 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
- Sign the informed consent form.
- At the time of signing the informed consent form, the age of 18 years old or above, both male and female.
- Bone marrow hematopoietic function is satisfied: white blood cell count ≥3×10^9/L; neutrophil count ≥1×10^9/L (not receiving colony-stimulating factor within 2 weeks prior to screening); hemoglobin ≥60g/L.
- Liver function fulfillment: ALT≤3×ULN; AST≤3×ULN; TBIL≤3×ULN.
- Renal function fulfillment: creatinine clearance CrCl ≥ 60mL/min.
- Coagulation function meets: international standard ratio INR <1.5 times ULN, prothrombin time PT <1.5 times ULN.
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- Patients with rheumatoid arthritis must also meet the following enrollment criteria:
- Diagnosis of rheumatoid arthritis according to the 2010 ACR / EULAR diagnostic criteria.
- Fulfillment of one of the following conditions: DAS28-ESR >3.2 or CDAI >10 at 3 months after use of a standard treatment regimen prior to screening; inability to taper hormones (prednisone) to less than 7.5 mg/day; and number of swollen joints and/or number of joints with tenderness ≥3. Standard treatment regimen is defined as the stable use of any of the following (alone or in combination): corticosteroids, nonsteroidal anti-inflammatory drugs ( NSAIDs) and csDMARDs, including methotrexate, leflunomide, hydroxychloroquine, salazosulfapyridine, elamodex, tretinoin, and paeonia lactiflora total, as well as biological agents (including TNF inhibitors, non-TNF inhibitors, and JAK inhibitors).
- Stable treatment with 1 or 2 cs DMARD(s) prior to enrollment as follows: at least 12 weeks of methotrexate and at least 4 weeks of administration at a dose of 7.5-25 mg/week; at least 4 weeks of stable hydroxychloroquine doses of ≤400 mg/d; at least 4 weeks of stable oral salicylazosulfapyridine 1 to 3 g/d; at least 4 weeks of stable oral leflunomide 10-20 mg /d.
- Patients with SLE will also be required to meet the following enrollment criteria:
- Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria for SLE.
- A history of SLE for at least 6 months prior to screening, with the disease remaining active 2 months after the use of a standard treatment regimen prior to screening. Standard treatment regimen is defined as stable use of any of the following (alone or in combination): corticosteroids, antimalarials, nonsteroidal anti-inflammatory drugs (NSAIDs), and other immunosuppressive or biologic agents, including azathioprine, mertiomaxolide, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine, belimumab, rituximab, and tetracycline.
- BILAG-2004 assessment of the presence of at least 1 grade A or 2 grade B organ scores.
- Positive for at least one of the following antibodies: anti-nuclear antibody, anti-ds-DNA antibody, anti-Sm antibody.
- SLEDAI-2000 score ≥ 8 during the screening period.
- Patients with dry syndrome were also required to meet the following enrollment criteria:
- Diagnosis of dry syndrome according to the 2002 International Classification Criteria for Primary Dry Syndrome or the 2016 ACR/EULAR classification criteria.
- Diagnosis of pSS-TP with platelet count <30 x 10^9/L.
- History of dry syndrome for at least 6 months prior to screening and disease still active 2 months after use of conventional treatment regimen prior to screening. Definition of conventional therapy:Use of glucocorticoids (above 1 mg/Kg/d) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, and cyclosporine, as well as biologics, such as rituximab, belimumab, and tetraciprazole.
- Patients with systemic sclerosis were also required to meet the following enrollment criteria:
- Diagnosis of systemic sclerosis according to the 2013 ACR classification criteria for systemic sclerosis.
- Positive antinuclear antibodies at screening.
- Presence of clear evidence of HRCT progression.
- History of systemic sclerosis for at least 6 months prior to screening, and active disease 2 months after use of a conventional treatment regimen prior to screening. Definition of conventional therapy:Use of glucocorticoids (above 0.5 mg/Kg/d) and cyclophosphamide for more than 6 months, as well as any of the following immunomodulatory medications: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, and cyclosporine, as well as biologics, such as rituximab and belimumab.
Who cannot join
- pre-screening presence of clinically significant CNS disease or pathological changes not caused by the disease itself, including, but not limited to: stroke, apoplexy, aneurysm, epilepsy, convulsions, aphasia, severe craniocerebral injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or insanity.
- Those suffering from relatively serious heart diseases such as angina pectoris, myocardial infarction, heart failure and arrhythmia.
- History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
- vaccination, B-cell targeted therapy within 4 weeks prior to screening.
- History of any malignant disease.
- Patients with end-stage renal failure.
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- Presence or suspected presence of uncontrolled fungal, bacterial, viral or other infections.
- History of severe allergy to drugs used in clinical studies or raw materials of test drugs, such as cyclophosphamide, fludarabine, DMSO.
- The patient is positive for HBV surface antigen, or HBV core antibody and positive for DNA by RT-PCR; positive for HCV antibody or positive for HIV antibody or positive for syphilis or positive for CMV DNA or positive for EBV DNA.
- Females who are pregnant or breastfeeding or who plan to have a pregnancy within 2 years of return infusion of the test drug; partners of male patients who plan to become pregnant within 2 years of treatment with the test drug.
- Evidence of active tuberculosis infection.
- other circumstances assessed by the investigator as unsuitable 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
Hunan Siweikang Therapeutic Co.Ltd
Changsha, Hunan, 410119
Zhu chen, M.D., 800-555-5555, doczchen@ustc.edu.cn
Zhu Chen Professor
About this study
Official title: An Exploratory Clinical Study of a Fourth-generation Autologous CAR-T Cell Injection (SCAR02) Targeting BCMA and CD19 for the Treatment of Refractory Autoimmune Diseases
This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART
- Conditions
- Autoimmune Diseases
- Being tested
- Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis.
- Keywords
- rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, systemic sclerosis
- Medical subject headings
- Autoimmune Diseases, Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis.Drug
A single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 0.5-3 x10^6 CART cells/kg）.
| Study group | Role | What they receive |
|---|---|---|
| Anti-BCMA and CD19 CART | Experimental | Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CART infusion. A dose of Anti-BCMA and CD19 CART will be infused on day 0. Receives: Drug: Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Total number, incidence and severity of adverse events (AEs) in patients of SCAR02 infusion. The AEs will be assessed according to the 2019 Consensus on Cytokine Release Syndrome and Immune-cell-associated Neurotoxicity published by the American Society of Transplantation and Cell Therapy (ASTCT), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and EBMT 2019 consensus.
Measured: up to 2 years
Secondary outcomes (19)
The persistence, accumulation, and migration of Anti-BCMA and CD19 CART cells
Assessing the trafficking of Anti-BCMA and CD19 CART cells in the peripheral blood at the time of each infusion as well as at each time of follow-up by Quantitative Real-time Polymerase Chain Reaction or flow cytometry. Peripheral blood will be collected prior to the initial infusion and will be set as baseline.
Measured: up to 2 years
Erythrocyte Sedimentation Rate
To evaluate disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
American College of Rheumatology (ACR) criteria 20, 50, 70 response rate
To evaluate RA disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Swollen and tender joint count
To evaluate RA disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Visual Analogue Scale
To evaluate RA disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2000) from baseline
Range [0, 105]，higher score represents worse disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in the Physician Global Assessment (PGA) score from baseline
Range [0, 3]，higher score represents worse disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in the BILAG-2004 score from baseline
Range [0, 72]，higher score represents worse disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in immunological indexes from baseline
Serum IgA, IgG and IgM will be evaluated
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in level of anti-nuclear antibody (ANA) in peripheral blood from baseline
To evaluate disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in level of anti-double stranded DNA (dsDNA) antibody in peripheral blood from baseline
To evaluate disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in levels of complement in peripheral blood from baseline
To evaluate SLE disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
To evaluate SLE disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in levels of anti-Ro/SSA antibodies in peripheral blood from baseline
To evaluate disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in levels of Changes in levels of anti-Ro/SSA antibodies in peripheral blood from baseline in peripheral blood from baseline
To evaluate disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in levels of Changes in levels of RF in peripheral blood from baseline in peripheral blood from baseline
To evaluate disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in levels of Changes in levels of anti-topoisomerase I antibody in peripheral blood from baseline in peripheral blood from baseline
To evaluate disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score from baseline
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) describes the patient's self-assessed degree of disability. HAQ-DI comprises 8 categories of questions rated from 0 to 3, where 3 indicates the worst degree of disability.
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in levels of Changes in levels of anti-RNA polymerase III antibody in peripheral blood from baseline in peripheral blood from baseline
To evaluate disease activity
Measured: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start9 Apr 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2028 (estimated)
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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zhu chen, M.D, Principal investigator, The First Affiliated Hospital of University of Science and Technology of Chinaxingbing wang, M.D, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503224
- Sponsor's protocol ID
- SWKCART24031101
- Acronym
- SCAR02
- Status last verified
- Apr 2025
- First submitted
- 7 Jul 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of a Fourth-generation Autologous CAR-T Cell Injection (SCAR02) Targeting BCMA and CD19 for the Treatment of Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT06503224
- Acronym / sponsor ID
- SCAR02 / SWKCART24031101
- Conditions
- Autoimmune Diseases
- Keywords
- rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, systemic sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of ChinaUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 16 Jul 2024 (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 an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-BCMA and CD19 CART | Experimental | Drug: Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis.Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CART infusion. A dose of Anti-BCMA and CD19 CART will be infused on day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Sign the informed consent form.
- At the time of signing the informed consent form, the age of 18 years old or above, both male and female.
- Bone marrow hematopoietic function is satisfied: white blood cell count ≥3×10^9/L; neutrophil count ≥1×10^9/L (not receiving colony-stimulating factor within 2 weeks prior to screening); hemoglobin ≥60g/L.
- Liver function fulfillment: ALT≤3×ULN; AST≤3×ULN; TBIL≤3×ULN.
- Renal function fulfillment: creatinine clearance CrCl ≥ 60mL/min.
Key exclusion criteria (12 listed)
- pre-screening presence of clinically significant CNS disease or pathological changes not caused by the disease itself, including, but not limited to: stroke, apoplexy, aneurysm, epilepsy, convulsions, aphasia, severe craniocerebral injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or insanity.
- Those suffering from relatively serious heart diseases such as angina pectoris, myocardial infarction, heart failure and arrhythmia.
- History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
- vaccination, B-cell targeted therapy within 4 weeks prior to screening.
- History of any malignant disease.
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 |
|---|---|---|
| Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis.A single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 0.5-3 x10^6 CART cells/kg）. | Drug | Anti-BCMA and CD19 CART |
Primary outcome
Adverse events
Time frame: up to 2 years
Total number, incidence and severity of adverse events (AEs) in patients of SCAR02 infusion. The AEs will be assessed according to the 2019 Consensus on Cytokine Release Syndrome and Immune-cell-associated Neurotoxicity published by the American Society of Transplantation and Cell Therapy (ASTCT), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and EBMT 2019 consensus.
19 secondary outcomes
The persistence, accumulation, and migration of Anti-BCMA and CD19 CART cells
Time frame: up to 2 years
Erythrocyte Sedimentation Rate
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
American College of Rheumatology (ACR) criteria 20, 50, 70 response rate
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Swollen and tender joint count
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Visual Analogue Scale
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2000) from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in the Physician Global Assessment (PGA) score from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in the BILAG-2004 score from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in immunological indexes from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in level of anti-nuclear antibody (ANA) in peripheral blood from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in level of anti-double stranded DNA (dsDNA) antibody in peripheral blood from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in levels of complement in peripheral blood from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in levels of anti-Ro/SSA antibodies in peripheral blood from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in levels of Changes in levels of anti-Ro/SSA antibodies in peripheral blood from baseline in peripheral blood from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in levels of Changes in levels of RF in peripheral blood from baseline in peripheral blood from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in levels of Changes in levels of anti-topoisomerase I antibody in peripheral blood from baseline in peripheral blood from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
Changes in levels of Changes in levels of anti-RNA polymerase III antibody in peripheral blood from baseline in peripheral blood from baseline
Time frame: Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24
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 24 Apr 2025.
- Individual participant dataSharing planned: Yes
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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.
zhu chen, M.D principal investigator
The First Affiliated Hospital of University of Science and Technology of China
xingbing wang, M.D principal investigator
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis. in people with Autoimmune Diseases, run by The First Affiliated Hospital of University of Science and Technology of China 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 25 inclusion and 12 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 24 Apr 2025. 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.
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 zhu chen, M.D (860551-62283843, doczchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: up to 2 years). 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 24 Apr 2025.