Multiple MyelomaPhase 1/2NCT04935580
Study of FasT CAR-T GC012F Injection in High Risk TE NDMM Patients
A Phase 1/2 study testing GC012F injection in people with Multiple Myeloma, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
This is a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of GC012F in high-risk, transplant eligible patients with NDMM. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- GC012F injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2021to 1 Jul 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should meet all of the following criteria:
- ≥18 years of age at the time of signing informed consent-upper age limit 70;
- High-risk defined as meet one or more of the following criteria at screen:
- R-ISS stage II or III;
- LDH > the upper limit of normal;
- Meet one or more of cytogenetic high risk defined by: del 17p, t(4:14), t(14:16); Gain 1q21≥ 4 copies;
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- Patients with extramedullary disease;
- IgD or IgE subtype;
- Meet one or more high-risk definition of mSMART3.0;
- Documented evidence of multiple myeloma at diagnosis as defined by IMWG guidelines CRAB (calcium elevation, renal insufficiency, anemia, and bone abnormalities)/SLiM criteria, monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytomas, and measurable secretory disease according to IMWG criteria meet one or more of the following criteria at screening:
- Serum M protein ≥ 1 g/dL;
- Urine M protein ≥ 200 mg/24h;
- Serum free light chain sFLC ≥ 10 mg/dL with abnormal serum immunoglobulin κ/λ free light chain ratio.
- ECOG score was 0-2 at screen;
- Estimated life expectancy ≥3 months;
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L without use of growth factors;
- Platelet count ≥ 75×10^9/L without transfusion support within 7 days before the screen;
- Hemoglobin≥ 80 g/L;
- Adequate functional reserve of organs:
- ALT/AST ≤ 2.5× UNL (upper normal limit);
- Creatinine clearance ≥ 40mL/min, or serum creatinine level ≤177μmol/L，may be calculated or measured according to local practice;
- Serum total bilirubin ≤ 1.5× UNL, except in subjects with congenital bilirubinemia, such as Gilbert syndrome, then direct bilirubin ≤ 1.5× UNL;
- The left ventricular ejection fraction (LVEF)≥50%, and no clinically significant ecg abnormalities were found;
- Basic oxygen saturation in natural indoor air: SPO2>92%.
- Adequate venous access for apheresis collection, and no other contraindications to apheresis;
- Subjects and sexual partner with fertility are willing to use effective and reliable method of contraception for at least 1 year after CART cell infusion, serum HCG should be negative in females with fertility both at screening andbaseline;
- Subjects must sign a written informed consent.
Who cannot join
- Patients should be excluded if they meet any one of the following criteria:
- Patients with purely non-secretory MM;
- Subject has had radiation therapy within 14 days of screening;
- Subjects has plasma cell leukemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);
- Subjects has a diagnosis of primary amyloidosis, Waldenstroem's disease, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma;
- Having other tumors (excluding non-melanoma skin cancer and cervical cancer in situ bladder cancer and breast cancer that have been disease-free for more than 5 years);
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- Overt clinical evidence of dementia or altered mental status; any history of central nervous system (CNS) disease or neurodegenerative disorder, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain damage, dementia, Parkinson's disease, psychosis;
- History of hereditary diseases such as Fanconi anemia, Schrader syndrome, Costerman syndrome, or any other known bone marrow failure syndrome;
- Clinically significant cardiac disease including: uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities, grade III-IV heart failure or myocardial infarction cardiac angioplasty or stenting unstable angina or other clinically significant cardiac conditions within one year prior to enrollment;
- Presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy catheter indwelling catheter bile drainage tube or pleural/peritoneal/pericardial catheter) permits the use of a dedicated central venous catheter;
- Subjects is exhibiting clinical signs of meningeal involvement of multiple myeloma;
- A positive virological result for any of the following: HIV, HCV, HBsAg, TPPA;
- Other severe viral or bacterial infections or uncontrolled systemic fungal infections are present;
- Subjects with a history of severe hypersensitivity;
- There is a history of an autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that has resulted in terminal organ damage or requires systemic immunosuppressive/disease modulating drugs in the past 2 years;
- Presence of lung disease (such as pulmonary fibrosis);
- Subjects has had major surgery within 2 weeks before screen or has not fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study;
- Poor compliance due to factors such as physiological family, social geography, etc., and inability to comply with the research program and follow-up plan;
- Pregnant or lactating women, or men who are planned to have babies during the period of participation in the study or within 1 year of receiving treatment;
- Investigator assessment deemed to be ineligible.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Juan Du, MD, +86215021598406, juan_du@live.com
About this study
Official title: Frontline Therapy of GC012F Injection in Transplant Eligible Newly Diagnosed Multiple Myeloma Patients With High-Risk Profile
This is a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of GC012F in high-risk, transplant eligible patients with NDMM.
Read the detailed description
Twenty evaluable subjects are planned to be enrolled in this study. Apheresis will be carried out in subjects who meet eligible criteria, and total 2 cycles of induction therapy (three-drug combination regimen based on bortezomib with details determined by the investigator according to the patient's condition) will be selectively given to subjects before or after apheresis. Next, subjects will receive a single infusion of GC012F, and the efficacy assessments will be performed at 1 month, 3 months, and every 3 months within 2 years until the end of the trial (MRD testing is required for each efficacy assessment),
1.Efficacy assessments performed at the 1st and 3rd months after infusion:
- <PR: Protocol change or transplantation or follow-up decided by the investigator.
- ≥PR: MRD positive: Protocol change or transplantation or follow-up decided by the investigator.
MRD negative: Wait for next follow-up.
2.Efficacy assessments performed at the 6th month after infusion and every 3 months thereafter:
- MRD positive: Protocol change or transplantation or follow-up decided by the investigator.
- MRD negative: Whether to carry out maintenance treatment using lenalidomide until the end of the trial will be determined by the investigator.
After signing the informed consent form (ICF), subjects will be followed up for efficacy and safety until 2 years after GC012F infusion, or disease progression, or death, or withdrawal of consent, or any intolerable toxicity, whichever comes first. All AEs in subjects, especially infection related symptoms and signs, will be closely monitored during follow-up, and prophylactic treatment will be administered according to clinical practice when necessary. In case of disease progression within 2 years after GC012F infusion, treatment will be administered according to clinical practice, and the survival follow-up (only for the survival status) will be performed every 12 weeks±14 days (2 weeks) until 2 years after infusion, or death, or withdrawal of consent, whichever comes first. For subjects who have undergone transportation or any other clinical routine treatments after GC012F infusion, survival follow-up will be also performed as described above.
- Conditions
- Multiple Myeloma
- Being tested
- GC012F injection
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC012F injectionBiological
GC012F injection is an autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| GC012F treatment | Experimental | GC012F will be infused at a dose of1- 3 x 10^5 CAR+ T cells/kg after receiving lymphodepleting chemotherapy. Lenalidomide maintenance therapy will be given post month 6 at physicians' choice. Receives: Biological: GC012F injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE) after GC012F infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), with the exception of cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). CRS and ICANS should be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Measured: Up to 1 year after patients infused with GC012F injection
Overall response rate (ORR) as measured by International Myeloma Working Group (IMWG) criteria after GC012F infusion
ORR defined as proportion of patients achieving PR or better based on IMWG defined response criteria
Measured: Up to 2 years after patients infused with GC012F injection
Percentage of patients with minimal residual disease (MRD) negative(tested by NGF at sensitivity of 10e-5 to 10e-4) at landmark analysis of 1/3/6/12/18/24 months post GC012F infusion
MRD negative rate is defined as the proportion of participants who achieve MRD negative status by the respective time point
Measured: Up to 2 years after patients infused with GC012F injection
Progress free survival (PFS) at 6 months, 12 months and 24 months after GC012F infusion
PFS defined as time from date of GC012F infusion to date of first documented disease progression, or death due to any cause, whichever occurs first. DOR defined as time form Month 1 after GC012F infusion to date of 1st documented PD if patients' response deeper or keeping sCR after CAR-T infusion.
Measured: Up to 2 years after patients infused with GC012F injection
Duration of response (DOR) at 6 months, 12 months and 24 months after GC012F infusion
DOR defined as time form Month 1 after GC012F infusion to date of 1st documented PD if patients' response deeper or keeping sCR after CAR-T infusion.
Measured: Up to 2 years after patients infused with GC012F injection
Secondary outcomes (11)
Overall survival (OS) after GC012F infusion
Response is defined as participant has met all criteria for PR or better according to IMWG criteria
Measured: Up to 2 years after patients infused with GC012F injection
Time to first response (TTR) after GC012F infusion
Response is defined as participant has met all criteria for PR or better according to IMWG criteria
Measured: Up to 2 years after patients infused with GC012F injection
Time to best response (TBR) after GC012F infusion
Response is defined as participant has met all criteria for PR or better according to IMWG criteria
Measured: Up to 2 years after patients infused with GC012F injection
Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by EORTC QLQ-C30
HRQoL will be assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQC30) items. Subscale and single item scores are reported on a 0-100 scale with higher scores representing better global health status, better functioning, and worst symptoms.
Measured: Baseline up to study completion ( 2 years after GC012F Infusion on Day 0
Change from Baseline in HRQoL as Measured by EORTC QLQ-MY20
HRQoL will be assessed by the EORTC QLQ-Multiple Myeloma ((MY20) module items. Subscale and single item scores are reported on a 0-100 scale with higher scores representing better global health status, better functioning, and worst symptoms.
Measured: Baseline up to study completion ( 2 years after GC012F Infusion on Day 0
Change from Baseline in Participant-reported Health Status Measured by EQ-5D- 5L
Participant-reported health status measured by the EuroQol Group 5-dimension, 5-level (EQ-5D-5L) questionnaire. A total utility score is reported based on the health status, ranging from 0 to 1, where higher values indicate better health utility. The visual analog scale ranges from 0 to 100 where higher values indicate better overall health status.
Measured: Baseline up to study completion ( 2 years after GC012F Infusion on Day 0
Change from Baseline in Pain Measured by PGIS Scale [Time Frame: Baseline up to study completion
Participant reported pain measured by Patient Global Impression of Severity (PGIS) Scale. The PGIS is a single item to assess pain severity. The 5-point verbal rating scale ranged from 1 (none) to 5 (very severe).
Measured: Baseline up to study completion ( 2 years after GC012F Infusion on Day 0
Level of CAR-T Cell Expansion (proliferation), and Persistence
Levels of GC012F cell expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.
Measured: Up to 2 years after patients infused with GC012F injection
Cytokines in the peripheral blood after GC012F infusion
Serum concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF), interleukin (IL)-6, IL-10, interferon-gamma (IFN-γ), soluble BCMA (sBCMA) and TNF-α after GC012F infusion
Measured: Up to 2 years after patients infused with GC012F injection
Serum concentrations of C-reaction protein (CRP)
Serum concentrations of C-reaction protein (CRP)
Measured: Up to 2 years after patients infused with GC012F injection
Number of patients with Anti-GC012F Antibodies, replication-competent lentivirus (RCL) after GC012F infusion
Number of patients exhibiting anti-drug antibodies for GC012F and RCL will be reported
Measured: Up to 2 years after patients infused with GC012F injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start28 Jun 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd.
- Responsible party
- Principal investigator, Juan Du, Shanghai Changzheng Hospital
- Investigators
- Juan Du, MD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935580
- Sponsor's protocol ID
- GC012F-32
- Status last verified
- Aug 2022
- First submitted
- 13 Jun 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontline Therapy of GC012F Injection in Transplant Eligible Newly Diagnosed Multiple Myeloma Patients With High-Risk Profile
- ClinicalTrials.gov ID
- NCT04935580
- Acronym / sponsor ID
- GC012F-32
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd.
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 23 Jun 2021 (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 a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of GC012F in high-risk, transplant eligible patients with NDMM.
Detailed description
Twenty evaluable subjects are planned to be enrolled in this study. Apheresis will be carried out in subjects who meet eligible criteria, and total 2 cycles of induction therapy (three-drug combination regimen based on bortezomib with details determined by the investigator according to the patient's condition) will be selectively given to subjects before or after apheresis. Next, subjects will receive a single infusion of GC012F, and the efficacy assessments will be performed at 1 month, 3 months, and every 3 months within 2 years until the end of the trial (MRD testing is required for each efficacy assessment),
1.Efficacy assessments performed at the 1st and 3rd months after infusion:
- <PR: Protocol change or transplantation or follow-up decided by the investigator.
- ≥PR: MRD positive: Protocol change or transplantation or follow-up decided by the investigator.
MRD negative: Wait for next follow-up.
2.Efficacy assessments performed at the 6th month after infusion and every 3 months thereafter:
- MRD positive: Protocol change or transplantation or follow-up decided by the investigator.
- MRD negative: Whether to carry out maintenance treatment using lenalidomide until the end of the trial will be determined by the investigator.
After signing the informed consent form (ICF), subjects will be followed up for efficacy and safety until 2 years after GC012F infusion, or disease progression, or death, or withdrawal of consent, or any intolerable toxicity, whichever comes first. All AEs in subjects, especially infection related symptoms and signs, will be closely monitored during follow-up, and prophylactic treatment will be administered according to clinical practice when necessary. In case of disease progression within 2 years after GC012F infusion, treatment will be administered according to clinical practice, and the survival follow-up (only for the survival status) will be performed every 12 weeks±14 days (2 weeks) until 2 years after infusion, or death, or withdrawal of consent, whichever comes first. For subjects who have undergone transportation or any other clinical routine treatments after GC012F infusion, survival follow-up will be also performed as described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC012F treatment | Experimental | Biological: GC012F injectionGC012F will be infused at a dose of1- 3 x 10^5 CAR+ T cells/kg after receiving lymphodepleting chemotherapy. Lenalidomide maintenance therapy will be given post month 6 at physicians' choice. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Patients should meet all of the following criteria:
Key exclusion criteria (20 listed)
- Patients should be excluded if they meet any one of the following criteria:
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 |
|---|---|---|
| GC012F injectionGC012F injection is an autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously. | Biological | GC012F treatment |
Primary outcome
Adverse Events (AE) after GC012F infusion
Time frame: Up to 1 year after patients infused with GC012F injection
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), with the exception of cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). CRS and ICANS should be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Overall response rate (ORR) as measured by International Myeloma Working Group (IMWG) criteria after GC012F infusion
Time frame: Up to 2 years after patients infused with GC012F injection
ORR defined as proportion of patients achieving PR or better based on IMWG defined response criteria
Percentage of patients with minimal residual disease (MRD) negative(tested by NGF at sensitivity of 10e-5 to 10e-4) at landmark analysis of 1/3/6/12/18/24 months post GC012F infusion
Time frame: Up to 2 years after patients infused with GC012F injection
MRD negative rate is defined as the proportion of participants who achieve MRD negative status by the respective time point
Progress free survival (PFS) at 6 months, 12 months and 24 months after GC012F infusion
Time frame: Up to 2 years after patients infused with GC012F injection
PFS defined as time from date of GC012F infusion to date of first documented disease progression, or death due to any cause, whichever occurs first. DOR defined as time form Month 1 after GC012F infusion to date of 1st documented PD if patients' response deeper or keeping sCR after CAR-T infusion.
Duration of response (DOR) at 6 months, 12 months and 24 months after GC012F infusion
Time frame: Up to 2 years after patients infused with GC012F injection
DOR defined as time form Month 1 after GC012F infusion to date of 1st documented PD if patients' response deeper or keeping sCR after CAR-T infusion.
11 secondary outcomes
Overall survival (OS) after GC012F infusion
Time frame: Up to 2 years after patients infused with GC012F injection
Time to first response (TTR) after GC012F infusion
Time frame: Up to 2 years after patients infused with GC012F injection
Time to best response (TBR) after GC012F infusion
Time frame: Up to 2 years after patients infused with GC012F injection
Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by EORTC QLQ-C30
Time frame: Baseline up to study completion ( 2 years after GC012F Infusion on Day 0
Change from Baseline in HRQoL as Measured by EORTC QLQ-MY20
Time frame: Baseline up to study completion ( 2 years after GC012F Infusion on Day 0
Change from Baseline in Participant-reported Health Status Measured by EQ-5D- 5L
Time frame: Baseline up to study completion ( 2 years after GC012F Infusion on Day 0
Change from Baseline in Pain Measured by PGIS Scale [Time Frame: Baseline up to study completion
Time frame: Baseline up to study completion ( 2 years after GC012F Infusion on Day 0
Level of CAR-T Cell Expansion (proliferation), and Persistence
Time frame: Up to 2 years after patients infused with GC012F injection
Cytokines in the peripheral blood after GC012F infusion
Time frame: Up to 2 years after patients infused with GC012F injection
Serum concentrations of C-reaction protein (CRP)
Time frame: Up to 2 years after patients infused with GC012F injection
Number of patients with Anti-GC012F Antibodies, replication-competent lentivirus (RCL) after GC012F infusion
Time frame: Up to 2 years after patients infused with GC012F injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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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.
Juan Du, MD principal investigator
Shanghai Changzheng Hospital
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 GC012F injection in people with Multiple Myeloma, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Du, MD (+86-21-81885423, changzheng_pg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) after GC012F infusion (time frame: Up to 1 year after patients infused with GC012F injection). The study lists 5 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 3 Aug 2022.