Refractory Immune-mediated Necrotizing MyopathyPhase 1/2NCT07752264
A Phase I/II Study of Eque-cel in Subjects Withimmune-mediated Necrotizing Myopathy
A Phase 1/2 study testing Equecabtagene Autoleucel Injection (Eque-cel) in people with Refractory Immune-mediated Necrotizing Myopathy, run by Nanjing IASO Biotechnology Co., Ltd. at 4 sites in China.
Trial summary
This is an open-label, single-arm Phase I/II clinical study to evaluate the efficacy and safety of Eque-cel Injection in patients with refractory immune-mediated necrotizing myopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Immune-mediated Necrotizing Myopathy
- What is being tested?
- Equecabtagene Autoleucel Injection (Eque-cel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesChina
- Study dates
- 15 Aug 2026to 15 Aug 2043
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. At the time of signing the informed consent form, the age is ≥ 18 years old.
- 2.Based on the 2016 ENMC classification criteria, the clinical diagnosis is IMNM.
- 3.At the time of screening, the anti-SRP antibody or anti-HMGCR antibody is positive.
- 4. Refractory IMNM that failed or relapsed after standard treatment, and the disease is still active at the time of screening.
- 5.The subjects must have appropriate organ functions.
- 6.The subjects and their spouses agree to take effective contraceptive measures (excluding safe period contraception) from the time of the subject signing the informed consent form until one year after the CAR-T cell infusion.
- 7. The subjects must agree to sign or personally write and present the informed consent form approved by the ethics committee before starting any screening procedures.
Who cannot join
- 1. Having end-stage myositis with involvement of terminal organs may pose additional risks or interfere with the study assessment.
- 2.Presence of irreversible muscle involvement and/or severe atrophy may bring additional risks or interfere with the study assessment.
- 3.Uncontrolled interstitial lung disease or any other uncontrolled manifestations of IIM, as judged by the investigator, may require the use of prohibited drugs during the study period.
- 4. Diagnosed with other inflammatory or non-inflammatory myopathies.
- 5.Any other known autoimmune disease that the investigator considers to interfere with the accurate assessment of clinical symptoms of IMNM or place the patient at excessive risk.
- 6. Those with a history of solid organ transplantation.
Show all 21Show fewer
- 7. History of autologous or allogeneic stem cell transplantation.
- 8. Previous history of BCMA-targeted drug treatment.
- 9.Having occurred or planned to undergo major surgery or surgical treatment within 4 weeks before enrollment or within 12 weeks after infusion.
- 10. Known primary immunodeficiency (congenital or acquired).
- 11. Having a clear history of mental disorder or a history of substance abuse for mental disorders that cannot be quit.
- 12.The subject has uncontrollable active fungal， viral， bacterial or other infections (having persistent infection-related signs/symptoms， without improvement after appropriate anti-infection treatment) or infections requiring intravenous anti-infection drug treatment.
- 13.Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and abnormal peripheral blood hepatitis B virus (HBV) DNA test (defined as HBV DNA quantification ≥ 100IU/ml or ≥ 1000 copies /ml or above the normal reference range of the testing center or positive for qualitative HBV DNA detection) ; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive (defined as ≥ 1000 IU/mL); human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive (defined as ≥ 1000 IU/mL); Treponema pallidum specific antibody positive and positive for the rapid plasma reagin test for syphilis.
- 14.Severe heart disease: including but not limited to unstable angina pectoris and/or myocardial infarction within 12 months of the screening period, any congestive heart failure (NYHA classification ≥ III), and a history of severe arrhythmia.
- 15.Severe asthma or chronic obstructive pulmonary disease (COPD). Note: Mild or moderate asthma or COPD patients with stable conditions, after assessment and approval by the investigator and the sponsor, can be enrolled.
- 16.Acute cerebrovascular disease events occurred within 6 months before enrollment, including transient ischemic attack or stroke history.
- 17.Any serious and/or uncontrolled comorbid diseases as determined by the investigator to potentially interfere with the study assessment.
- 18.Malignant tumors within 5 years before screening, excluding cured cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, locally advanced prostate cancer after radical surgery, breast duct carcinoma in situ after radical surgery, or thyroid papillary carcinoma after radical surgery.
- 19. Known history of allergy to cyclophosphamide, fludarabine, components of Eque-cel injection or supportive drugs required for toxicity management of CAR-T cell therapy (such as tocilizumab).
- 21.Pregnant or lactating women.
- 21. Other situations as determined by the investigator to be unsuitable for enrollment.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Xin Lu
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040
Wenhua Zhu
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Shengyun Liu
About this study
Official title: An Open-label, Single-arm Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Equecabtagene Autoleucel Injection (Eque-cel) in Subjects With Immune-mediated Necrotizing Myopathy
This is an open-label, single-arm Phase I/II clinical study to evaluate the efficacy and safety of Eque-cel Injection in patients with refractory immune-mediated necrotizing myopathy.
Read the detailed description
This study is an open-label, single-arm Phase I/II clinical trial evaluating the safety and efficacy of Eque-cel in subjects with immune-mediated necrotizing myopathy (IMNM). The study consists of two phases: Phase I and Phase II. The Phase I component will evaluate the safety, tolerability and preliminary efficacy of Eque-cel to identify the recommended Phase 2 dose (RP2D). Following RP2D determination from Phase I, the Phase II stage will enroll additional subjects at this dose level to confirm the efficacy of Eque-cel injection in patients with IMNM. All subjects will undergo a primary follow-up period of 2 years after infusion of Eque-cel injection, followed by long-term follow-up extending up to 15 years.
- Being tested
- Equecabtagene Autoleucel Injection (Eque-cel)
- Keywords
- Immune-mediated necrotizing myopathy, Refractory, Eque-cel, anti-SRP antibody, anti-HMGCR antibody, MMT-8
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equecabtagene Autoleucel Injection (Eque-cel)Drug
Also called FUCASO
Eque-cel is a personalized, BCMA-targeted gene-modified autologous T-cell immunotherapy product capable of recognizing and eliminating both malignant and normal cells expressing BCMA. The CAR specifically identifies BCMA via a fully human single-chain variable fragment (scFv) with low immunogenicity, activates, proliferates, secretes cytokines, and kills target cells through the CD3ζ domain, while enhancing CAR-T expansion and persistence via 4-1BB costimulation signaling. Eque-cel demonstrates high affinity for the BCMA antigen both in vitro and in vivo, as well as efficient killing of antigen-loaded cells.
| Study group | Role | What they receive |
|---|---|---|
| Equecabtagene Autoleucel Injection（Eque-cel） | Experimental | Eligible subjects will receive single intravenous infusion of Eque-cel Injection after successful screening and baseline assessment. Eque-cel Injection will be infused at 1.0 x 10^6 CAR-T cells/kg or 0.5 x 10^6 CAR-T cells/kg。 Receives: Drug: Equecabtagene Autoleucel Injection (Eque-cel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Safety endpoint - Adverse Events (AEs)
Incidence and severity of adverse events as assessed by NCI-CTCAE v5.0 (except CRS and ICANS assessed according to the criteria of 2019 ASTCT criteria).
Measured: up to 2 years from Eque-cel Injection infusion
Phase I: Safety endpoint-incidence of Dose-limiting toxicity (DLT)
Percentage of participants who experienced DLT within 28 days after Eque-cel administration.
Measured: Time Frame: up to 28 days from Eque-cel Injection infusion
Phase II: Efficacy endpoint- TIS response
Proportion of participants achieving TIS response
Measured: up to the 2 years after Eque-cel Injection infusion
Secondary outcomes (20)
Phase I: Efficacy endpoint -TIS response
Proportion of participants achieving TIS response
Measured: up to the 2 years after Eque-cel Injection Infusion
Phase II:Efficacy endpoint -Proportion of participants achieving minimal improvement response (TIS ≥ 20 points)
Defined as achieving The Total Improvement Score (TIS)≥ 20 points (minimum improvement)
Measured: From baseline to 12 months after Eque-cel Injection Infusion
Phase I/II:Efficacy endpoint -Change in mean Total Improvement Score (TIS) value
Defined as achieving the Total Improvement Score (TIS)
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -The changes in PtGA scores
The PhGA scale will be completed by patients at each study visit.
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -The changes in PhGA scores
The PhGA scale will be completed by investigators at each study visit.
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint-MMT-8
The changes in Manual Muscle Testing-8 (MMT-8) As measured by testing proximal muscles.
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -HAO Scale
HAQ will be completed by subjects at each study visit.
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -CK
Changes in the levels of Creatine Kinase (CK)
Measured: up to 2 years from Eque-cel Injection infusion
The changes in MDAAT scores
MDAAT will be completed by investigators at each study visit.
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -hormone dosage reduction
The proportion of subjects whose hormone dosage reduction.
Measured: From baseline to 6 and 12 months after Eque-cel Injection Infusion
Phase II:Safety endpoint - Adverse Events (AEs)
Incidence and severity of adverse events as assessed by NCI-CTCAE v5.0 (except CRS and ICANS assessed according to the criteria of 2019 ASTCT criteria)
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - Cmax (CAR-T cells)
The maximum concentration (Cmax) of BCMA CAR-T in peripheral blood after CAR-T infusion.
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - Tmax (CAR-T cells)
The time for BCMA CAR-T to reach the maximum concentration (Tmax) after CAR-T infusion.
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - AUC (CAR-T cells)
Area under the curve of 28 days, 90 days and the last time point. (AUC0-28d, AUC0-90,AUC0-last) for BCMA CAR-T.
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - Cmax (VCN)
The maximum concentration (Cmax) of lentiviral vector copy number (VCN) in peripheral blood after infusion.
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - Tmax (VCN)
The time for VCN to reach the maximum concentration (Tmax) after infusion.
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - AUC (VCN)
Area under the curve of 28 days, 90 days and the last time point (AUC0-28d, AUC0-90d, AUC0-last) for VCN.
Measured: up to 2 years from Eque-cel Injection infusion
hase I/II Pharmacodynamic Endpoint - inflammatory markers
Changes in levels of inflammatory markers, including CRP, Ferritin, and IL-6.
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacodynamic Endpoint - Serum immunoglobulin
Changes in serum immunoglobulin (IgG, IgA, IgM) levels from baseline.
Measured: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacodynamic Endpoint-sBCMA
The concentration of soluble BCMA in peripheral blood of experimental group at each time point.
Measured: up to 2 years from Eque-cel Injection infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Aug 2030 (estimated)
- Study completion15 Aug 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Immune-mediated Necrotizing MyopathyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752264
- Sponsor's protocol ID
- CT103AC006
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Equecabtagene Autoleucel Injection (Eque-cel) in Subjects With Immune-mediated Necrotizing Myopathy
- ClinicalTrials.gov ID
- NCT07752264
- Acronym / sponsor ID
- CT103AC006
- Keywords
- Immune-mediated necrotizing myopathy, Refractory, Eque-cel, anti-SRP antibody, anti-HMGCR antibody, MMT-8
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2030 (estimated)
- Study completion
- 15 Aug 2043 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-arm Phase I/II clinical study to evaluate the efficacy and safety of Eque-cel Injection in patients with refractory immune-mediated necrotizing myopathy.
Detailed description
This study is an open-label, single-arm Phase I/II clinical trial evaluating the safety and efficacy of Eque-cel in subjects with immune-mediated necrotizing myopathy (IMNM). The study consists of two phases: Phase I and Phase II. The Phase I component will evaluate the safety, tolerability and preliminary efficacy of Eque-cel to identify the recommended Phase 2 dose (RP2D). Following RP2D determination from Phase I, the Phase II stage will enroll additional subjects at this dose level to confirm the efficacy of Eque-cel injection in patients with IMNM. All subjects will undergo a primary follow-up period of 2 years after infusion of Eque-cel injection, followed by long-term follow-up extending up to 15 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Equecabtagene Autoleucel Injection（Eque-cel） | Experimental | Drug: Equecabtagene Autoleucel Injection (Eque-cel)Eligible subjects will receive single intravenous infusion of Eque-cel Injection after successful screening and baseline assessment. Eque-cel Injection will be infused at 1.0 x 10^6 CAR-T cells/kg or 0.5 x 10^6 CAR-T cells/kg。 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. At the time of signing the informed consent form, the age is ≥ 18 years old.
- 2.Based on the 2016 ENMC classification criteria, the clinical diagnosis is IMNM.
- 3.At the time of screening, the anti-SRP antibody or anti-HMGCR antibody is positive.
- 4. Refractory IMNM that failed or relapsed after standard treatment, and the disease is still active at the time of screening.
- 5.The subjects must have appropriate organ functions.
Key exclusion criteria (21 listed)
- 1. Having end-stage myositis with involvement of terminal organs may pose additional risks or interfere with the study assessment.
- 2.Presence of irreversible muscle involvement and/or severe atrophy may bring additional risks or interfere with the study assessment.
- 3.Uncontrolled interstitial lung disease or any other uncontrolled manifestations of IIM, as judged by the investigator, may require the use of prohibited drugs during the study period.
- 4. Diagnosed with other inflammatory or non-inflammatory myopathies.
- 5.Any other known autoimmune disease that the investigator considers to interfere with the accurate assessment of clinical symptoms of IMNM or place the patient at excessive risk.
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 |
|---|---|---|
| Equecabtagene Autoleucel Injection (Eque-cel)Also: FUCASOEque-cel is a personalized, BCMA-targeted gene-modified autologous T-cell immunotherapy product capable of recognizing and eliminating both malignant and normal cells expressing BCMA. The CAR specifically identifies BCMA via a fully human single-chain variable fragment (scFv) with low immunogenicity, activates, proliferates, secretes cytokines, and kills target cells through the CD3ζ domain, while enhancing CAR-T expansion and persistence via 4-1BB costimulation signaling. Eque-cel demonstrates high affinity for the BCMA antigen both in vitro and in vivo, as well as efficient killing of antigen-loaded cells. | Drug | Equecabtagene Autoleucel Injection（Eque-cel） |
Primary outcome
Phase I: Safety endpoint - Adverse Events (AEs)
Time frame: up to 2 years from Eque-cel Injection infusion
Incidence and severity of adverse events as assessed by NCI-CTCAE v5.0 (except CRS and ICANS assessed according to the criteria of 2019 ASTCT criteria).
Phase I: Safety endpoint-incidence of Dose-limiting toxicity (DLT)
Time frame: Time Frame: up to 28 days from Eque-cel Injection infusion
Percentage of participants who experienced DLT within 28 days after Eque-cel administration.
Phase II: Efficacy endpoint- TIS response
Time frame: up to the 2 years after Eque-cel Injection infusion
Proportion of participants achieving TIS response
20 secondary outcomes
Phase I: Efficacy endpoint -TIS response
Time frame: up to the 2 years after Eque-cel Injection Infusion
Phase II:Efficacy endpoint -Proportion of participants achieving minimal improvement response (TIS ≥ 20 points)
Time frame: From baseline to 12 months after Eque-cel Injection Infusion
Phase I/II:Efficacy endpoint -Change in mean Total Improvement Score (TIS) value
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -The changes in PtGA scores
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -The changes in PhGA scores
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint-MMT-8
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -HAO Scale
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -CK
Time frame: up to 2 years from Eque-cel Injection infusion
The changes in MDAAT scores
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -hormone dosage reduction
Time frame: From baseline to 6 and 12 months after Eque-cel Injection Infusion
Phase II:Safety endpoint - Adverse Events (AEs)
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - Cmax (CAR-T cells)
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - Tmax (CAR-T cells)
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - AUC (CAR-T cells)
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - Cmax (VCN)
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - Tmax (VCN)
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - AUC (VCN)
Time frame: up to 2 years from Eque-cel Injection infusion
hase I/II Pharmacodynamic Endpoint - inflammatory markers
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacodynamic Endpoint - Serum immunoglobulin
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacodynamic Endpoint-sBCMA
Time frame: up to 2 years from Eque-cel Injection infusion
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 7 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Equecabtagene Autoleucel Injection (Eque-cel) in people with Refractory Immune-mediated Necrotizing Myopathy, run by Nanjing IASO Biotechnology Co., Ltd. at 4 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 7 inclusion and 21 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Phase I: Safety endpoint - Adverse Events (AEs) (time frame: up to 2 years from Eque-cel Injection infusion). The study lists 3 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 7 Aug 2026.