Relapsing Multiple SclerosisPhase 1/2NCT06617793
An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis
A Phase 1/2 study testing rapcabtagene autoleucel (YTB323) in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 18 sites in 6 countries.
Trial summary
This is an open-label, multi-center, non-confirmatory study to assess the safety, efficacy, and cellular kinetics of YTB323 in approximately 28 participants with Relapsing Multiple Sclerosis (RMS) with breakthrough disease activity during previous treatment with a highly efficacious therapy (BD-HET). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- rapcabtagene autoleucel (YTB323)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 24 Feb 2025to 7 Aug 2030
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent, and able to communicate well with the investigator and comply with the requirements of the study
- Adequate renal, hepatic, cardiac, hematological, and pulmonary function
- Male or female participants, ≥18 years to ≤60 years at screening, with diagnosis of RMS according to the 2017 McDonald diagnostic criteria Evidence of recent (i.e. within 1 year) breakthrough disease activity while at least 6 months on a highly efficacious therapy (any of the following): rituximab (Rituxan®), ocrelizumab (Ocrevus®), natalizumab (Tysabri®), ofatumumab (Kesimpta®), ublituximab (Briumvi®) or evidence of breakthrough disease activity within 2 years after the latest alemtuzumab infusion (Lemtrada®).
- Evidence of breakthrough disease activity is defined as one or more of the following:
- Confirmed Clinical MS relapse
- Persistent radiological activity defined by one of the following:
Show all 12Show fewer
- ≥2 T1 gadolinium-enhancing lesions on a single MRI scan
- ≥1 T1 gadolinium-enhancing lesions on two or more separate MRI scans
- ≥2 new T2 lesions compared to a previous scan within a period ≤1 year
- Ambulatory patients (EDSS of 3 to 6 points, inclusive assessed outside of relapse)
- Disease duration less than 15 years
- Participants must receive or be current on all recommended vaccinations according to institutional, local, or global guidelines for immunocompromised patients at least 6-weeks prior to lymphodepletion
Who cannot join
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria at screening
- History of or current clinically significant CNS disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS or ICANS at screening
- Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 6 months prior to screening), neurological disorders other than MS (including seizure disorders even when well controlled), psychiatric, pulmonary (including, history of or active severe respiratory disease, including Chronic Obstructive Pulmonary Disease, interstitial lung disease or pulmonary fibrosis), renal, hepatic, endocrine, metabolic (e.g. severe hypoproteinemia due to nephrotic syndrome), hematological disorders or gastrointestinal disease that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant, prior to screening
- Have donated blood or experienced a loss of blood > 400 mL within 3 months prior screening, or longer if required by local regulations
- Any prior stem cell therapy or organ transplantation or gene therapy
- Any contraindications to LP, including but not limited to:
Show all 11Show fewer
- Known or suspected structural abnormality of the lumbar spine that, in the opinion of the Investigator, may interfere with the performance of the LP, or increase the risk of the procedure for the participant
- Presence of risk for increased or uncontrolled bleeding including, but not limited to, vascular abnormalities or neoplasms at or near the LP site, disorders of the coagulation cascade, platelet function, or platelet count
- Participants on anticoagulants (e.g., warfarin) or antiplatelets [except for low-dose aspirin (100 mg/day or lower) and low-dose ibuprofen (600 mg/day or lower) which are allowable], are not eligible to participate
- Participants not willing or able to take MRI scans as per protocol. Unable to undergo MRI due to for example claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Germany4 sites
Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Ulm, 89081
Spain4 sites
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Córdoba, 14004
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Valencia, 46026
France3 sites
Novartis Investigative Site
Montpellier, 34090
Novartis Investigative Site
Nancy, 54035
Novartis Investigative Site
Rennes, 35033
Switzerland3 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Lausanne, 1011
Novartis Investigative Site
Zurich, 8091
Australia2 sites
Novartis Investigative Site
Darlinghurst, New South Wales, 2010
Novartis Investigative Site
Melbourne, Victoria, 3004
Italy2 sites
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Milan, MI, 20132
About this study
Official title: An Open-label, Multi-center, Phase 1/2 Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Participants With Relapsing Multiple Sclerosis With Breakthrough Disease Activity During Previous Treatment With a Highly Efficacious Therapy
This is an open-label, multi-center, non-confirmatory study to assess the safety, efficacy, and cellular kinetics of YTB323 in approximately 28 participants with Relapsing Multiple Sclerosis (RMS) with breakthrough disease activity during previous treatment with a highly efficacious therapy (BD-HET). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort.
Read the detailed description
All participants in this study will receive YTB323. Both the participant and the study doctor will know the participant is getting YTB323. Participants will be given one dose of YTB323. Different groups of participants may receive a higher dose of YTB323, if proven to be safe for every participant at the lower dose. Participants are in this study for 2 years and will be followed for an additional 13 years in a long-term follow up study. The main question this trial is designed to answer: Is YTB323 treatment safe for participants with relapsing MS?
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- rapcabtagene autoleucel (YTB323)
- Keywords
- Chimeric Antigen Receptor T cells, CAR-T, YTB323, Multiple Sclerosis, MS, Relapsing Multiple Sclerosis, RMS, breakthrough disease activity during previous treatment with a highly efficacious therapy, BD-HET
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapcabtagene autoleucel (YTB323)Biological
CAR-T cell suspension for intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| YTB323 Cohort 1 | Experimental | Participants will receive one dose of YTB323 Receives: Biological: rapcabtagene autoleucel (YTB323) |
| YTB323 Cohort 2 | Experimental | Participants will receive one dose of YTB323 Receives: Biological: rapcabtagene autoleucel (YTB323) |
| YTB323 Cohort 3 | Experimental | Participants will receive one dose of YTB323 Receives: Biological: rapcabtagene autoleucel (YTB323) |
| YTB323 Cohort 4 | Experimental | Participants will receive one dose of YTB323 Receives: Biological: rapcabtagene autoleucel (YTB323) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence of dose limiting toxicities (DLTs), AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs), laboratory parameters, neurological status and magnetic resonance (MRI) of the brain and spinal cord qualifying and reported as AEs.
Measured: Day 1 through Year 2
Secondary outcomes (15)
Measure of Disability: Expanded Disability Status Scale (EDSS).
EDSS is used to measure the change in disability level in participants using a scale from 0 to 10. The higher the score, the greater the degree of disability.
Measured: Day 1 through Year 2
Measure of Disability: Short Form Health Survey (SF-36 v2)
The Short Form Health Survey (SF-36 v2) is a widely used and extensively studied instrument to measure health-related quality of life among healthy participants and participants with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The SF 36 has proven useful in monitoring general and specific populations, comparing the relative burden of different diseases, differentiating the health benefits produced by different treatments, and in screening individual participants.
Measured: Day 1 through Year 2
Measure of Disability: Timed 25 Foot Walk (T25FW)
The T25FW is a mobility test based on a timed walk of 25 feet that is administered by a trained administrator. The participant is directed to walk the clearly marked 25-foot distance as quickly as possible. Longer completion time corresponds with decreased mobility.
Measured: Day 1 through Year 2
Measure of Disability: 9 Hole Peg Test (9HPT)
The 9HPT is a finger dexterity test that is administered by a trained administrator. The participant is directed to put 9 pegs, one by one, onto and then off the holder board as quickly as possible starting with using only the dominant hand, and then repeated with the non-dominant hand. Longer completion times are associated with decreased finger dexterity.
Measured: Day 1 through Year 2
Measure of Disability: Symbol Digit Modalities Test (SDMT)
The SDMT is a timed cognition test administered by a trained administrator. The test assesses sustained attention, processing speed, visual scanning, and motor speed to determine cognitive impairment. Participants are given a coding key which contains abstract symbols that correspond to specific numbers. Participants are timed how quickly and accurately they are able to substitute the symbols for the numbers and is scored by the number of correctly coded items.
Measured: Day 1 through Year 2
Measure of Disability: Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS)
The FSIQ-RMS is a questionnaire to assess fatigue-related symptoms in patients with RMS. Participants will indicate the severity of fatigue experienced for each question that examines different aspects of fatigue.
Measured: Day 1 through Year 2
Number of new and enlarging T2 lesions and Gd-enhancing T1 Lesions
Measured in the brain by Magnetic Residence Imaging (MRI)
Measured: Day 1 through Year 2
Plasma Pharmacokinetics (PK) of YTB323 - CMAX
Measured by Cmax - The maximum plasma concentration of YTB323
Measured: Day 1 through Year 2
Plasma Pharmacokinetics (PK) of YTB323 - AUC
Measured by AUC - Area under the curve of YTB323
Measured: Day 1 through Year 2
Plasma Pharmacokinetics (PK) of YTB323 - Tmax
Measured by Tmax - Time to Reach the Maximum Concentration After Drug Administration of YTB323
Measured: Day 1 through Year 2
Plasma Pharmacokinetics (PK) of YTB323 - Clast
Clast is defined as the Last observed (quantifiable) plasma concentration (Clast)
Measured: Day 1 through Year 2
Plasma Pharmacokinetics (PK) of YTB323 - Tlast
Tlast is defined as Time of Last Measurable Concentration
Measured: Day 1 through Year 2
Safety data including dose limiting toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs) from each dose level
Safety data from each dose level will be used to assess safe dose-level(s) to be continued in phase 2 and later clinical studies
Measured: Day 1 through Year 2
Humoral Immunogenicity of YTB323
Incidence and prevalence of pre-existing and treatment induced humoral immunogenicity of YTB323
Measured: Day 1 through Year 2
Cellular Immunogenicity of YTB323
Incidence and prevalence of pre-existing and treatment induced cellular immunogenicity of YTB323
Measured: Day 1 through Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start24 Feb 2025
- Primary completion7 Aug 2030 (estimated)
- Study completion7 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617793
- Sponsor's protocol ID
- CYTB323N12101
- Other IDs
- 2024-512714-18
- Status last verified
- Aug 2026
- First submitted
- 26 Sep 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Phase 1/2 Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Participants With Relapsing Multiple Sclerosis With Breakthrough Disease Activity During Previous Treatment With a Highly Efficacious Therapy
- ClinicalTrials.gov ID
- NCT06617793
- Acronym / sponsor ID
- CYTB323N12101
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- Chimeric Antigen Receptor T cells, CAR-T, YTB323, Multiple Sclerosis, MS, Relapsing Multiple Sclerosis, RMS, breakthrough disease activity during previous treatment with a highly efficacious therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 7 Aug 2030 (estimated)
- Study completion
- 7 Aug 2030 (estimated)
- First posted
- 27 Sep 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, multi-center, non-confirmatory study to assess the safety, efficacy, and cellular kinetics of YTB323 in approximately 28 participants with Relapsing Multiple Sclerosis (RMS) with breakthrough disease activity during previous treatment with a highly efficacious therapy (BD-HET). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort.
Detailed description
All participants in this study will receive YTB323. Both the participant and the study doctor will know the participant is getting YTB323. Participants will be given one dose of YTB323. Different groups of participants may receive a higher dose of YTB323, if proven to be safe for every participant at the lower dose. Participants are in this study for 2 years and will be followed for an additional 13 years in a long-term follow up study. The main question this trial is designed to answer: Is YTB323 treatment safe for participants with relapsing MS?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YTB323 Cohort 1 | Experimental | Biological: rapcabtagene autoleucel (YTB323)Participants will receive one dose of YTB323 |
| YTB323 Cohort 2 | Experimental | Biological: rapcabtagene autoleucel (YTB323)Participants will receive one dose of YTB323 |
| YTB323 Cohort 3 | Experimental | Biological: rapcabtagene autoleucel (YTB323)Participants will receive one dose of YTB323 |
| YTB323 Cohort 4 | Experimental | Biological: rapcabtagene autoleucel (YTB323)Participants will receive one dose of YTB323 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Signed informed consent, and able to communicate well with the investigator and comply with the requirements of the study
- Adequate renal, hepatic, cardiac, hematological, and pulmonary function
- Male or female participants, ≥18 years to ≤60 years at screening, with diagnosis of RMS according to the 2017 McDonald diagnostic criteria Evidence of recent (i.e. within 1 year) breakthrough disease activity while at least 6 months on a highly efficacious therapy (any of the following): rituximab (Rituxan®), ocrelizumab (Ocrevus®), natalizumab (Tysabri®), ofatumumab (Kesimpta®), ublituximab (Briumvi®) or evidence of breakthrough disease activity within 2 years after the latest alemtuzumab infusion (Lemtrada®).
- Confirmed Clinical MS relapse
- Persistent radiological activity defined by one of the following:
Key exclusion criteria (11 listed)
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria at screening
- History of or current clinically significant CNS disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS or ICANS at screening
- Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 6 months prior to screening), neurological disorders other than MS (including seizure disorders even when well controlled), psychiatric, pulmonary (including, history of or active severe respiratory disease, including Chronic Obstructive Pulmonary Disease, interstitial lung disease or pulmonary fibrosis), renal, hepatic, endocrine, metabolic (e.g. severe hypoproteinemia due to nephrotic syndrome), hematological disorders or gastrointestinal disease that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant, prior to screening
- Have donated blood or experienced a loss of blood > 400 mL within 3 months prior screening, or longer if required by local regulations
- Any prior stem cell therapy or organ transplantation or gene 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 |
|---|---|---|
| rapcabtagene autoleucel (YTB323)CAR-T cell suspension for intravenous infusion | Biological | YTB323 Cohort 1, YTB323 Cohort 2, YTB323 Cohort 3, YTB323 Cohort 4 |
Primary outcome
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 through Year 2
Incidence of dose limiting toxicities (DLTs), AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs), laboratory parameters, neurological status and magnetic resonance (MRI) of the brain and spinal cord qualifying and reported as AEs.
15 secondary outcomes
Measure of Disability: Expanded Disability Status Scale (EDSS).
Time frame: Day 1 through Year 2
Measure of Disability: Short Form Health Survey (SF-36 v2)
Time frame: Day 1 through Year 2
Measure of Disability: Timed 25 Foot Walk (T25FW)
Time frame: Day 1 through Year 2
Measure of Disability: 9 Hole Peg Test (9HPT)
Time frame: Day 1 through Year 2
Measure of Disability: Symbol Digit Modalities Test (SDMT)
Time frame: Day 1 through Year 2
Measure of Disability: Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS)
Time frame: Day 1 through Year 2
Number of new and enlarging T2 lesions and Gd-enhancing T1 Lesions
Time frame: Day 1 through Year 2
Plasma Pharmacokinetics (PK) of YTB323 - CMAX
Time frame: Day 1 through Year 2
Plasma Pharmacokinetics (PK) of YTB323 - AUC
Time frame: Day 1 through Year 2
Plasma Pharmacokinetics (PK) of YTB323 - Tmax
Time frame: Day 1 through Year 2
Plasma Pharmacokinetics (PK) of YTB323 - Clast
Time frame: Day 1 through Year 2
Plasma Pharmacokinetics (PK) of YTB323 - Tlast
Time frame: Day 1 through Year 2
Safety data including dose limiting toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs) from each dose level
Time frame: Day 1 through Year 2
Humoral Immunogenicity of YTB323
Time frame: Day 1 through Year 2
Cellular Immunogenicity of YTB323
Time frame: Day 1 through Year 2
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 Sep 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing rapcabtagene autoleucel (YTB323) in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 18 sites in 6 countries.
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 12 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, Spain, France, Switzerland, Australia and 1 more country. 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?
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Day 1 through Year 2). 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 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.