COVID-19Phase 1/2NCT05370040

THEMBA II T-Cell Vaccine: Vaccination With saRNA COVID-19 Vaccines

A Phase 1/2 study testing AAHI-SC2 Vaccine, AAHI-SC3 Vaccine and EUA or approved vaccine in people with COVID-19, run by ImmunityBio, Inc. at 1 site in South Africa.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This is a phase 1/2 open-label study assessing the safety, reactogenicity, and immunogenicity of saRNA COVID-19 boost vaccines in participants that have been previously vaccinated against or previously infected with COVID-19. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: AAHI-SC2 Vaccine, AAHI-SC3 Vaccine and EUA or approved vaccine
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteSouth Africa
Study dates: 5 May 2022to 11 Mar 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults ≥ 18 years of age at time of enrollment.
Vaccinated with an EUA or approved vaccine against COVID-19 ≥ 3 months prior to enrollment on study or infection with COVID-19 ≥ 3 months prior to enrollment on study.
Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
Agrees to the collection of biospecimens (eg, nasopharyngeal [NP] swabs) and venous blood per protocol.
Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
Temperature < 38°C.
Agreement to practice effective contraception for female participants of childbearing potential and non-sterile males. Female participants of childbearing potential must agree to use effective contraception while on study until at least 1 month after the last dose of vaccine. Non-sterile male participants must agree to use a condom while on study until at least 1 month after the last dose of vaccine. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm), intrauterine devices (IUDs), oral contraceptives, injectable contraceptives, patches, implants and abstinence.
HIV-positive participants must have been on anti-retroviral therapy for ≥ 4 weeks and have HIV-1 viral load < 1,000 copies/mL at the time of enrollment.

Who cannot join

Serious adverse reaction to any vaccine, any unrelated medication or any component of the investigational vaccine, including a history of anaphylaxis and symptoms of a severe allergic reaction and history of allergies in the past.
Confirmed current COVID-19, previous SARS-CoV-2 infection in the last < 3 months, or PCR positive for SARS-CoV-2 at screening.
Vaccinated with an EAU-approved vaccine against COVID-19 in the last < 3 months.
Pregnant or breastfeeding women.
Chronic lung disease (included COPD) as evidenced by one or more exacerbations requiring a course of steroids in the last year, or the requiring chronic low dose oral steroids to prevent exacerbations. Uncontrolled asthma, defined as requiring reliever inhaler (short-acting beta agonist or ipratromium bromide) more than twice a week is also excluded.
Bone marrow or organ transplant recipient

Show all 17Show fewer

Extreme obesity (defined as BMI of 40 kg/m2 or higher).
Chronic kidney disease requiring dialysis.
History of liver disease.
Any disease associated with acute fever, or any infection.
Participants with acquired or hereditary immunodeficiencies other than well-controlled HIV are excluded from enrollment.
Current diagnosis of active tuberculosis.
History of hereditary, idiopathic or acquired angioedema.
No spleen or functional asplenia.
Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, or immunomodulators. The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.
According to the judgement of the investigator any medical, psychiatric, psychological, social, occupational or other conditions that could affect the participants ability to sign informed consent, provide safety assessment data or comply with the requirements of the study protocol.
Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Wits Vida
Johannesburg

Other trials in South Africa

About this study

Official title: THEMBA II T-CELL Vaccine: A Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of Vaccination With saRNA COVID-19 Vaccines

Conditions: COVID-19
Being tested: AAHI-SC2 Vaccine, AAHI-SC3 Vaccine, EUA or approved vaccine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AAHI-SC2 VaccineBiological
AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
AAHI-SC3 VaccineBiological
AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
EUA or approved vaccineBiological
Janssen or Pfizer vaccines (control arm)

Study groups in NCT05370040
Study group	Role	What they receive
Phase 1 Cohort 1A	Experimental	AAHI-SC2 on Day 1 at dosage 25 μg IM Receives: Biological: AAHI-SC2 Vaccine
Phase 1 Cohort 1B	Experimental	AAHI-SC2 on Day 1 at dosage 50 μg IM Receives: Biological: AAHI-SC2 Vaccine
Phase 1 Cohort 1C	Experimental	AAHI-SC2 on Day 1 at dosage 70 μg IM Receives: Biological: AAHI-SC2 Vaccine
Phase 1 Cohort 2A	Experimental	AAHI-SC3 on Day 1 at dosage 25 μg IM Receives: Biological: AAHI-SC3 Vaccine
Phase 1 Cohort 2B	Experimental	AAHI-SC3 on Day 1 at dosage 50 μg IM Receives: Biological: AAHI-SC3 Vaccine
Phase 1 Cohort 2C	Experimental	AAHI-SC3 on Day 1 at dosage 85 μg IM Receives: Biological: AAHI-SC3 Vaccine
Phase 2 Control arm	Placebo comparator	EUA or approved vaccine on Day 1 Receives: Biological: EUA or approved vaccine
Phase 2 Experimental arm 1	Experimental	AAHI-SC2 on Day 1 Dose TBD as determined in phase 1 study Receives: Biological: AAHI-SC2 Vaccine
Phase 2 Experimental arm 2	Experimental	AAHI-SC3 on Day 1 Dose TBD as determined in phase 1 study Receives: Biological: AAHI-SC3 Vaccine
Phase 2 Experimental arm 3	Experimental	AAHI-SC3 on Day 1 and 29 Dose TBD as determined in phase 1 study Receives: Biological: AAHI-SC3 Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1 Safety - Incidence of MAAEs Through 1 Week
Incidence of medically-attended adverse events (MAAEs)
Measured: through 1 week post final vaccine administration
Phase 1 Safety - Incidence of MAAEs Through 30 Days
Incidence of MAAEs
Measured: through 30 days post final vaccine administration
Phase 1 Safety - Incidence of MAAEs Through 6 Months
Incidence of MAAEs
Measured: through 6 months post final vaccine administration
Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs
Incidence and severity of solicited local reactogenicity AEs
Measured: through 1 week after each vaccine dose
Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs
Incidence and severity of solicited systemic reactogenicity AEs
Measured: through 1 week after each vaccine dose
Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week
Incidence and severity of unsolicited AEs
Measured: through 1 week post final vaccine administration
Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days
Incidence and severity of unsolicited AEs
Measured: through 30 days post final vaccine administration
Phase 1 Safety - Incidence of SAEs Through 1 Week
Incidence of serious adverse events (SAEs)
Measured: through 1 week post final vaccine administration
Phase 1 Safety - Incidence of SAEs Through 30 Days
Incidence of SAEs
Measured: through 30 days post final vaccine administration
Phase 1 Safety - Incidence of SAEs Through 6 Months
Incidence of SAEs
Measured: through 6 months post final vaccine administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 202211 Mar 2024

First posted11 May 2022
Study start5 May 2022
Primary completion11 Mar 2024
Study completion11 Mar 2024

Why it stopped: Discontinued prior to enroll in Phase 2

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by ImmunityBio, Inc.The 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: Randomised
Intervention model: Sequential
Model description: Open label 6 Cohort Phase 1 Study leading to Randomized 4 Cohort Phase 2 Study
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05370040
Sponsor's protocol ID: COVID-4.015
Status last verified: Feb 2025
First submitted: 9 May 2022
Last updated: 11 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: THEMBA II T-CELL Vaccine: A Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of Vaccination With saRNA COVID-19 Vaccines
ClinicalTrials.gov ID: NCT05370040
Acronym / sponsor ID: COVID-4.015
Conditions: COVID-19
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Discontinued prior to enroll in Phase 2
Enrolment: 60 participants (actual)
Lead sponsor: ImmunityBio, Inc.Industry (pharma, biotech, devices)
Study start: 5 May 2022 (actual)
Primary completion: 11 Mar 2024 (actual)
Study completion: 11 Mar 2024 (actual)
First posted: 11 May 2022 (actual)
Results: Posted 1 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 10
Model description: Open label 6 Cohort Phase 1 Study leading to Randomized 4 Cohort Phase 2 Study

Arm	Type	Receives
Phase 1 Cohort 1A	Experimental	Biological: AAHI-SC2 VaccineAAHI-SC2 on Day 1 at dosage 25 μg IM
Phase 1 Cohort 1B	Experimental	Biological: AAHI-SC2 VaccineAAHI-SC2 on Day 1 at dosage 50 μg IM
Phase 1 Cohort 1C	Experimental	Biological: AAHI-SC2 VaccineAAHI-SC2 on Day 1 at dosage 70 μg IM
Phase 1 Cohort 2A	Experimental	Biological: AAHI-SC3 VaccineAAHI-SC3 on Day 1 at dosage 25 μg IM
Phase 1 Cohort 2B	Experimental	Biological: AAHI-SC3 VaccineAAHI-SC3 on Day 1 at dosage 50 μg IM
Phase 1 Cohort 2C	Experimental	Biological: AAHI-SC3 VaccineAAHI-SC3 on Day 1 at dosage 85 μg IM
Phase 2 Control arm	Placebo comparator	Biological: EUA or approved vaccineEUA or approved vaccine on Day 1
Phase 2 Experimental arm 1	Experimental	Biological: AAHI-SC2 VaccineAAHI-SC2 on Day 1 Dose TBD as determined in phase 1 study
Phase 2 Experimental arm 2	Experimental	Biological: AAHI-SC3 VaccineAAHI-SC3 on Day 1 Dose TBD as determined in phase 1 study
Phase 2 Experimental arm 3	Experimental	Biological: AAHI-SC3 VaccineAAHI-SC3 on Day 1 and 29 Dose TBD as determined in phase 1 study

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Healthy adults ≥ 18 years of age at time of enrollment.
Vaccinated with an EUA or approved vaccine against COVID-19 ≥ 3 months prior to enrollment on study or infection with COVID-19 ≥ 3 months prior to enrollment on study.
Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
Agrees to the collection of biospecimens (eg, nasopharyngeal [NP] swabs) and venous blood per protocol.
Ability to attend required study visits and return for adequate follow-up, as required by this protocol.

Key exclusion criteria (17 listed)

Serious adverse reaction to any vaccine, any unrelated medication or any component of the investigational vaccine, including a history of anaphylaxis and symptoms of a severe allergic reaction and history of allergies in the past.
Confirmed current COVID-19, previous SARS-CoV-2 infection in the last < 3 months, or PCR positive for SARS-CoV-2 at screening.
Vaccinated with an EAU-approved vaccine against COVID-19 in the last < 3 months.
Pregnant or breastfeeding women.
Chronic lung disease (included COPD) as evidenced by one or more exacerbations requiring a course of steroids in the last year, or the requiring chronic low dose oral steroids to prevent exacerbations. Uncontrolled asthma, defined as requiring reliever inhaler (short-acting beta agonist or ipratromium bromide) more than twice a week is also excluded.

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
AAHI-SC2 VaccineAAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine	Biological	Phase 1 Cohort 1A, Phase 1 Cohort 1B, Phase 1 Cohort 1C, Phase 2 Experimental arm 1
AAHI-SC3 VaccineAAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine	Biological	Phase 1 Cohort 2A, Phase 1 Cohort 2B, Phase 1 Cohort 2C, Phase 2 Experimental arm 2, Phase 2 Experimental arm 3
EUA or approved vaccineJanssen or Pfizer vaccines (control arm)	Biological	Phase 2 Control arm

Primary outcome

Phase 1 Safety - Incidence of MAAEs Through 1 Week
Time frame: through 1 week post final vaccine administration
Incidence of medically-attended adverse events (MAAEs)
Phase 1 Safety - Incidence of MAAEs Through 30 Days
Time frame: through 30 days post final vaccine administration
Incidence of MAAEs
Phase 1 Safety - Incidence of MAAEs Through 6 Months
Time frame: through 6 months post final vaccine administration
Incidence of MAAEs
Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs
Time frame: through 1 week after each vaccine dose
Incidence and severity of solicited local reactogenicity AEs
Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs
Time frame: through 1 week after each vaccine dose
Incidence and severity of solicited systemic reactogenicity AEs
Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week
Time frame: through 1 week post final vaccine administration
Incidence and severity of unsolicited AEs
Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days
Time frame: through 30 days post final vaccine administration
Incidence and severity of unsolicited AEs
Phase 1 Safety - Incidence of SAEs Through 1 Week
Time frame: through 1 week post final vaccine administration
Incidence of serious adverse events (SAEs)
Phase 1 Safety - Incidence of SAEs Through 30 Days
Time frame: through 30 days post final vaccine administration
Incidence of SAEs
Phase 1 Safety - Incidence of SAEs Through 6 Months
Time frame: through 6 months post final vaccine administration
Incidence of SAEs

Results and safety

Results posted to the registry on 1 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1 Cohort 1A	10	10
Phase 1 Cohort 1B	10	10
Phase 1 Cohort 1C	10	9
Phase 1 Cohort 2A	10	10
Phase 1 Cohort 2B	10	9
Phase 1 Cohort 2C	10	10

Primary outcome: Phase 1 Safety - Incidence of MAAEs Through 1 Week

Time frame: through 1 week post final vaccine administration. Count of participants. Unit: Participants

Measure	Phase 1 Cohort 1A n = 10	Phase 1 Cohort 1B n = 10	Phase 1 Cohort 1C n = 10	Phase 1 Cohort 2A n = 10	Phase 1 Cohort 2B n = 10	Phase 1 Cohort 2C n = 10
Value	1	2	1	0	0	0

Primary outcome: Phase 1 Safety - Incidence of MAAEs Through 30 Days

Time frame: through 30 days post final vaccine administration. Count of participants. Unit: Participants

Measure	Phase 1 Cohort 1A n = 10	Phase 1 Cohort 1B n = 10	Phase 1 Cohort 1C n = 10	Phase 1 Cohort 2A n = 10	Phase 1 Cohort 2B n = 10	Phase 1 Cohort 2C n = 10
Value	2	2	2	2	0	1

Primary outcome: Phase 1 Safety - Incidence of MAAEs Through 6 Months

Time frame: through 6 months post final vaccine administration. Count of participants. Unit: Participants

Measure	Phase 1 Cohort 1A n = 10	Phase 1 Cohort 1B n = 10	Phase 1 Cohort 1C n = 10	Phase 1 Cohort 2A n = 10	Phase 1 Cohort 2B n = 10	Phase 1 Cohort 2C n = 10
Value	5	3	2	2	2	2

Primary outcome: Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs

Time frame: through 1 week after each vaccine dose. Count of participants. Unit: Participants

Measure	Phase 1 Cohort 1A n = 10	Phase 1 Cohort 1B n = 10	Phase 1 Cohort 1C n = 10	Phase 1 Cohort 2A n = 10	Phase 1 Cohort 2B n = 10	Phase 1 Cohort 2C n = 10
Value	9	9	9	8	9	9

Adverse events

Time frame: For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1 Cohort 1A	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Phase 1 Cohort 1B	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Phase 1 Cohort 1C	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Phase 1 Cohort 2A	1 of 10 (10%)	0 of 10 (0%)	0 of 10
Phase 1 Cohort 2B	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Phase 1 Cohort 2C	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Group 1: Cohort 1A	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Group 1: Cohort 1B	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Group 1: Cohort 1C	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Group 1: Cohort 2A	0 of 10 (0%)	8 of 10 (80%)	0 of 10
Group 1: Cohort 2B	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Group 1: Cohort 2C	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Group 2: Cohort 1A	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Group 2: Cohort 1B	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Group 2: Cohort 1C	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Group 2: Cohort 2A	0 of 10 (0%)	8 of 10 (80%)	0 of 10
Group 2: Cohort 2B	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Group 2: Cohort 2C	0 of 10 (0%)

Limitations and caveats (from the sponsor): The study was terminated early. Only the safety data is provided. Only one adverse event table per AE category was presented to reduce data entry redundancy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Phase 1/2 study testing AAHI-SC2 Vaccine, AAHI-SC3 Vaccine and EUA or approved vaccine in people with COVID-19, run by ImmunityBio, Inc. at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 11 Mar 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 South Africa. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 1 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 1 Safety - Incidence of MAAEs Through 1 Week (time frame: through 1 week post final vaccine administration). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05370040.

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 11 Mar 2025.