Relapsed Multiple MyelomaPhase 1/2NCT04083534
First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)
A Phase 1/2 study testing REGN5459 in people with Relapsed Multiple Myeloma and Refractory Multiple Myeloma, run by Regeneron Pharmaceuticals at 7 sites in United States.
Trial summary
In the phase 1 portion of the study, the primary objectives are to assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) of REGN5459 as monotherapy in patients with relapsed or refractory multiple myeloma (MM) who have exhausted all therapeutic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- REGN5459
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Sep 2019to 1 May 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Patients must have myeloma that is response-evaluable according to the 2016 International Myeloma Working Group (IMWG) response criteria
- Measurable disease is defined as 1 or more of the following:
- Serum M-protein ≥1 g/dL,
- Urine M-protein ≥200 mg/24-hour, and/or
- Free light chain (FLC) assay with involved FLC level ≥10 mg/dL with an abnormal serum FLC ratio
Show all 23Show fewer
- A patient with Immunoglobulin A (IgA) myeloma but without measurable M-protein may be enrolled if quantitative IgA levels are ≥400 mg/dL and can be followed longitudinally
- A patient with non-secretory MM may be considered for enrollment after discussion with the sponsor that includes the feasibility of an individualized plan for response assessment
- Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease, or intolerance of the therapy, and including either:
- Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory imide drug (IMiD), and an anti-CD38 antibody, OR
- Progression on or after an anti-CD38 antibody and having disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor. Refractory disease is defined as lack of response or relapse within 60 days of last treatment.
- Adequate hematologic function as measured by:
- Platelet count > 50 x 109/L. A patient may not have received a platelet transfusion within 7 days to meet this platelet eligibility requirement.
- ANC > 1.0 x 109/L. A patient may not have received granulocyte colony stimulating factor (G-CSF) within 2 days to meet this absolute neutrophil count eligibility requirement.
- Hemoglobin > 8.0 g/dL
- Adequate hepatic function, defined as:
- Total bilirubin ≤1.5 x ULN
- Transaminase (ALT, AST) ≤2.5 x ULN
- Alkaline phosphatase ≤2.5 x ULN
- Patients with Gilbert syndrome do not need to meet this total bilirubin requirement provided that the total bilirubin is unchanged from the baseline value.
- Serum creatinine clearance by Cockcroft-Gault >30 mL/min
- A patient with a creatinine clearance by Cockcroft-Gault who does not meet eligibility criteria may be considered for enrollment if a measured creatinine clearance (based on 24-hour urine collection or other reliable method) is >30 mL/min
- Life expectancy of at least 6 months
Who cannot join
- Patients with known MM brain lesions or meningeal involvement
- History of neurodegenerative condition or central nervous system (CNS) movement disorder, or patients with a history of seizure within 12 months before study enrollment are excluded
- Cardiac ejection fraction <40% by echocardiogram or multi-gated acquisition scan (MUGA)
- Prior treatment with any anti-BCMA antibody (including antibody-drug conjugate or bispecific antibody) or BCMA-directed CAR T therapy
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; or other uncontrolled infection
- Patients with HIV who have controlled infection (undetectable viral load and CD4 count above 350 cells/microliter either spontaneously or on a stable antiviral regimen) are permitted.
Show all 10Show fewer
- Patients with hepatitis B (Hepatitis B Surface Antigen Test positive [HepBsAg+]) who have controlled infection (serum HBV DNA polymerase chain reaction [PCR] that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted.
- Patients who are HCV antibody-positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by polymerase chain reaction (PCR) either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.
- History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment
- NOTE: Other protocol defined Inclusion/Exclusion Criteria apply.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Regeneron Study Site
Ann Arbor, Michigan, 48109
Regeneron Study Site
Dallas, Texas, 75390
Regeneron Study Site
Houston, Texas, 77030
Regeneron Study Site
Indianapolis, Indiana, 46202
Regeneron Study Site
Milwaukee, Wisconsin, 53226
Regeneron Study Site
New York, New York, 10029
Regeneron Study Site
Rochester, Minnesota, 55905
About this study
Official title: Phase 1/2 FIH Study of REGN5459 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma
In the phase 1 portion of the study, the primary objectives are to assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) of REGN5459 as monotherapy in patients with relapsed or refractory multiple myeloma (MM) who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit.
In the phase 2 portion of the study, the primary objective is to assess the preliminary anti-tumor activity of REGN5459 as measured by objective response rate (ORR).
Read more
In the phase 1 and phase 2 portion, the secondary objectives of the study are:
- To assess the preliminary anti-tumor activity of REGN5459 as measured by duration of response (DOR), progression-free survival (PFS), rate of minimal residual disease (MRD) negative status, and overall survival (OS)
- To evaluate the pharmacokinetic (PK) properties of REGN5459
- To characterize the immunogenicity of REGN5459
- To evaluate the effects of REGN5459 on patient-reported quality of life (QoL), symptoms, functioning and general health status
In the phase 1 portion of the study only, the secondary objective of the study is to assess the preliminary anti-tumor activity of REGN5459 as measured by ORR.
In the phase 2 portion of the study only, the secondary objective of the study is to evaluate the safety and tolerability of REGN5459.
- Being tested
- REGN5459
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN5459Drug
Administered by intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| REGN5459 | Experimental | Cohorts of multiple REGN5459 dose levels Receives: Drug: REGN5459 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Phase 1
Measured: Up to 35 Days
Incidence and severity of treatment-emergent adverse events (TEAEs) during REGN5459 treatment period
Phase 1
Measured: Up to 12 Weeks After the Last Dose
Incidence and severity of adverse events of special interest (AESI) with REGN5459 treatment period
Phase 1
Measured: Up to 12 Weeks After the Last Dose
Objective response rate (ORR) as measured using the International Myeloma Working Group (IMWG) criteria
Phase 2
Measured: Up to Approximately 104 Weeks
Secondary outcomes (15)
Concentrations of REGN5459 in the serum over time
Phase 1 and phase 2
Measured: Up to 12 Weeks After the Last Dose
Incidence over time of anti-drug antibodies (ADAs) to REGN5459
Phase 1 and phase 2
Measured: Up to 12 Weeks After the Last Dose
Duration of response (DOR) using the IMWG criteria
Phase 1 and phase 2
Measured: Up to Approximately 104 Weeks
Progression-free survival (PFS) as measured using the IMWG criteria
Phase 1 and phase 2
Measured: Up to Approximately 104 Weeks
Rate of minimal residual disease (MRD) negative status using the IMWG criteria
Phase 1 and phase 2
Measured: Up to Approximately 104 Weeks
Overall survival (OS)
Phase 1 and phase 2
Measured: Up to Approximately 104 Weeks
Patient-reported Quality of Life (QOL) per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Phase 1 and phase 2
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Measured: Up to 12 Weeks After the Last Dose
Patient-reported QOL per EORTC Quality of Life Questionnaire-Multiple Myeloma module 20 (EORTC QLQ-MY20)
Phase 1 and phase 2
The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.
Measured: Up to 12 Weeks After the Last Dose
Patient-reported QOL per EuroQoL-5 Dimension-3 Level Scale (EQ-5D-3L)
Phase 1 and phase 2
The EQ-5D-3L is a self-administered generic standardized health status measure, consisting of an EQ-5D descriptive system and an EQ visual analog scale. The EQ-5D-3L descriptive system assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 3-level scale: no problems, some problems, and extreme problems. The EQ visual analog scale component is a vertical visual analog scale used by patients to rate their health.
Measured: Up to 12 Weeks After the Last Dose
Change in patient-reported global health status/QOL per EORTC QLQ-C30
Phase 1 and phase 2
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Measured: Baseline up to 12 Weeks After the Last Dose
Time to definitive deterioration in patient-reported global health status/QOL per EORTC QLQ-C30
Phase 1 and phase 2
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Measured: Up to 12 Weeks After the Last Dose
Change in patient-reported general health status per EQ-5D-3L
Phase 1 and phase 2
The EQ-5D-3L is a self-administered generic standardized health status measure, consisting of an EQ-5D descriptive system and an EQ visual analog scale. The EQ-5D-3L descriptive system assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 3-level scale: no problems, some problems, and extreme problems. The EQ visual analog scale component is a vertical visual analog scale used by patients to rate their health.
Measured: Baseline up to 12 Weeks After the Last Dose
ORR as measured using the IMWG criteria
Phase 1 Only
Measured: Up to Approximately 104 Weeks
Incidence and severity of TEAEs during REGN5459 treatment period
Phase 2 Only
Measured: Up to 12 Weeks After the Last Dose
Incidence and severity of AESI during REGN5459 treatment period
Phase 2 Only
Measured: Up to 12 Weeks After the Last Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start26 Sep 2019
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Regeneron 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials Investigator, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083534
- Sponsor's protocol ID
- R5459-ONC-1888
- Other IDs
- 2019-001108-39, 2019
- Status last verified
- Feb 2026
- First submitted
- 29 Aug 2019
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual patient data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 FIH Study of REGN5459 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04083534
- Acronym / sponsor ID
- R5459-ONC-1888
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 10 Sep 2019 (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.
In the phase 1 portion of the study, the primary objectives are to assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) of REGN5459 as monotherapy in patients with relapsed or refractory multiple myeloma (MM) who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit.
In the phase 2 portion of the study, the primary objective is to assess the preliminary anti-tumor activity of REGN5459 as measured by objective response rate (ORR).
In the phase 1 and phase 2 portion, the secondary objectives of the study are:
- To assess the preliminary anti-tumor activity of REGN5459 as measured by duration of response (DOR), progression-free survival (PFS), rate of minimal residual disease (MRD) negative status, and overall survival (OS)
- To evaluate the pharmacokinetic (PK) properties of REGN5459
- To characterize the immunogenicity of REGN5459
- To evaluate the effects of REGN5459 on patient-reported quality of life (QoL), symptoms, functioning and general health status
In the phase 1 portion of the study only, the secondary objective of the study is to assess the preliminary anti-tumor activity of REGN5459 as measured by ORR.
In the phase 2 portion of the study only, the secondary objective of the study is to evaluate the safety and tolerability of REGN5459.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REGN5459 | Experimental | Drug: REGN5459Cohorts of multiple REGN5459 dose levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Patients must have myeloma that is response-evaluable according to the 2016 International Myeloma Working Group (IMWG) response criteria
- Measurable disease is defined as 1 or more of the following:
- A patient with Immunoglobulin A (IgA) myeloma but without measurable M-protein may be enrolled if quantitative IgA levels are ≥400 mg/dL and can be followed longitudinally
- A patient with non-secretory MM may be considered for enrollment after discussion with the sponsor that includes the feasibility of an individualized plan for response assessment
Key exclusion criteria (10 listed)
- Patients with known MM brain lesions or meningeal involvement
- History of neurodegenerative condition or central nervous system (CNS) movement disorder, or patients with a history of seizure within 12 months before study enrollment are excluded
- Cardiac ejection fraction <40% by echocardiogram or multi-gated acquisition scan (MUGA)
- Prior treatment with any anti-BCMA antibody (including antibody-drug conjugate or bispecific antibody) or BCMA-directed CAR T therapy
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; or other uncontrolled infection
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 |
|---|---|---|
| REGN5459Administered by intravenous (IV) infusion | Drug | REGN5459 |
Primary outcome
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Time frame: Up to 35 Days
Phase 1
Incidence and severity of treatment-emergent adverse events (TEAEs) during REGN5459 treatment period
Time frame: Up to 12 Weeks After the Last Dose
Phase 1
Incidence and severity of adverse events of special interest (AESI) with REGN5459 treatment period
Time frame: Up to 12 Weeks After the Last Dose
Phase 1
Objective response rate (ORR) as measured using the International Myeloma Working Group (IMWG) criteria
Time frame: Up to Approximately 104 Weeks
Phase 2
15 secondary outcomes
Concentrations of REGN5459 in the serum over time
Time frame: Up to 12 Weeks After the Last Dose
Incidence over time of anti-drug antibodies (ADAs) to REGN5459
Time frame: Up to 12 Weeks After the Last Dose
Duration of response (DOR) using the IMWG criteria
Time frame: Up to Approximately 104 Weeks
Progression-free survival (PFS) as measured using the IMWG criteria
Time frame: Up to Approximately 104 Weeks
Rate of minimal residual disease (MRD) negative status using the IMWG criteria
Time frame: Up to Approximately 104 Weeks
Overall survival (OS)
Time frame: Up to Approximately 104 Weeks
Patient-reported Quality of Life (QOL) per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: Up to 12 Weeks After the Last Dose
Patient-reported QOL per EORTC Quality of Life Questionnaire-Multiple Myeloma module 20 (EORTC QLQ-MY20)
Time frame: Up to 12 Weeks After the Last Dose
Patient-reported QOL per EuroQoL-5 Dimension-3 Level Scale (EQ-5D-3L)
Time frame: Up to 12 Weeks After the Last Dose
Change in patient-reported global health status/QOL per EORTC QLQ-C30
Time frame: Baseline up to 12 Weeks After the Last Dose
Time to definitive deterioration in patient-reported global health status/QOL per EORTC QLQ-C30
Time frame: Up to 12 Weeks After the Last Dose
Change in patient-reported general health status per EQ-5D-3L
Time frame: Baseline up to 12 Weeks After the Last Dose
ORR as measured using the IMWG criteria
Time frame: Up to Approximately 104 Weeks
Incidence and severity of TEAEs during REGN5459 treatment period
Time frame: Up to 12 Weeks After the Last Dose
Incidence and severity of AESI during REGN5459 treatment period
Time frame: Up to 12 Weeks After the Last Dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. All individual patient data (IPD) that underlie publicly available results will be considered for sharing
Related trials for Relapsed Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 3
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1/2
A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Multiple Myeloma
RecruitingObservational study
Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
Graft-versus-leukemia, Graft vs Host Disease
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.
Clinical Trials Investigator study director
Regeneron Pharmaceuticals
7 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 REGN5459 in people with Relapsed Multiple Myeloma and Refractory Multiple Myeloma, run by Regeneron Pharmaceuticals at 7 sites in United States.
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 23 inclusion and 10 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: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period (time frame: Up to 35 Days). The study lists 4 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 4 May 2026.