Relapsed or Refractory Acute Lymphoblastic LeukemiaPhase 2NCT04684147
Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia
A Phase 2 study testing single dose of CNCT19 in people with Relapsed or Refractory Acute Lymphoblastic Leukemia, run by Juventas Cell Therapy Ltd. at 11 sites in China.
Trial summary
The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsed or Refractory Acute Lymphoblastic Leukemia
- What is being tested?
- single dose of CNCT19
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 11 sitesChina
- Study dates
- 24 Dec 2020to 31 Dec 2026
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent is signed by the subject.
- Age 18 to 65.
- Relapsed or refractory acute lymphoblastic leukemia (ALL). (1) Relapse within 12 months of first remission; (2)a. Without remission after more than 6 weeks of induction chemotherapy or without remission after 2 cycles of induction chemotherapy regimen; c. 2nd or greater Bone Marrow (BM) relapse OR; d. First relapse after chemotherapy, without remission after at least 1 rescue treatment; e. Any BM relapse after autologous or allogeneic stem cell transplantation (SCT).
- Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months of study entry.
- Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 generation of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a T315I mutation.
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.
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- Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
- Adequate organ function defined as:
- aspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN);
- Serum alanine aminotransferase (ALT) ≤ 3 upper limit of normal (ULN);
- Total bilirubin ≤ 2 ULN, except in individuals with Gilbert's syndrome; Note: Patients with Gilbert's syndrome that bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN will be eligible;
- A serum creatinine≤ 1.5 ULN or Creatine removal rate ≥ 60mL/min (Cockcroft and Gault）;
- Must have a minimum level of pulmonary reserve as ≤ Grade 1 dyspnea and oxygen saturation > 91% on room air;
- International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (APTT) ≤ 1.5 ULN.
- Vascular conditions for apheresis.
- Women of childbearing age have a negative blood / urine pregnancy test within 3 days before apheresis and the CNCT19 infusion. Women of child-bearing potential and all male participants must use highly effective methods of contraception throughout the study and for a period of at least two years after the CNCT19 infusion.
Who cannot join
- Active Central Nervous System (CNS) involvement by malignancy.
- Isolated extra-medullary disease relapse.
- Patients who received chemotherapy within 2 weeks before CNCT19 infusion. The following situations are excluded:
- Lymphodepleting Chemotherapy prescribed by the protocol;
- Tyrosine kinase inhibitors (TKI) and hydroxyurea must be stopped > 72 hours prior to CNCT19 infusion;
- The following drugs must be stopped > 1 week prior to CNCT19 infusion: 6-mercaptopurine, 6-thioguanine, methotrexate (<25 mg / m2), cytosine arabinoside (<100 mg / m2 / d), vincristine, asparaginase;
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- CNS prophylaxis treatment must be stopped > 1 week prior to CNCT19 infusion;
- Pegylated-asparaginase must be stopped > 4 weeks prior to CNCT19 infusion.
- Radiotherapy before CNCT19 infusion:
- Non-CNS site of radiation completed < 2 weeks prior to CNCT19 Infusion; CNS directed radiation completed < 8 weeks prior to CNCT19 infusion.
- Therapeutic systemic doses of steroids were stopped < 72 hours prior to CNCT19 infusion. However, the following physiological replacement doses of steroids are allowed: < 10 mg/day hydrocortisone or equivalent.
- Has received anthracycline/anthraquinone drug treatment exceeding the maximum cumulative dose recommended by the guidelines, estimated by investigators before screening, as follows:
- Doxorubicin: 550mg/m2 (radiotherapy or combined medication, <(radiotherapy or combined medication, <350~400 mg/m2);
- Epirubicin: 900~1000 mg/m2 (Adriamycin used, <800 mg/m2);
- Pirarubicin: 950 mg/m2;
- Daunorubicin: 550 mg/m2;
- Demethoxydaunorubicin: 290 mg/m2;
- Aclarithromycin: 2000 mg/m2 (Adriamycin used, <800 mg/m2);
- Mitoxantrone: 160 mg/m2 (using doxorubicin, <120 mg/m2);
- Has had treatment with any prior CAR-T therapy.
- Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening; Patients who have received systemic drug therapy for GVHD within 4 weeks before CNCT19 infusion.
- Patients with systemic vasculitis.
- Patients complying with any of hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection, hepatitis C antibody (HCV-Ab) positive, anti-treponemia pallidum antibody (TP-Ab) positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection.
- Prior malignancy. Patients with Prior malignancy that has been cured for ≥ 5 years or has a low risk of relapse, judged by investigators are excluded.
- a. Left Ventricular Ejection Fraction (LVEF) ≤45%; b. III/IV congestive heart failure (NYHA); c. Severe arrhythmia, or clinically significant conduction abnormalities that can be seen on ECG, including QTc interval ≥480ms (QTcB=QT/RR1/2); d. Hypertension that has not been controlled after standard treatment (systolic ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg); e. Unstable angina; f. Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery < 6 months prior to CNCT19 infusion; f. Clinically significant valvular disease; g. Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy.
- Clinically significant pleural effusion.
- Patients with a history of epilepsy, cerebrovascular ischemia / hemorrhage, cerebellar disease or other active central nervous system diseases.
- History of deep vein thrombosis or pulmonary embolism within 6 months of screening.
- Known history of hypersensitivity to ingredients used in the drug.
- Has had treat with live vaccine within 6 weeks prior to screening.
- Patients with active infections in screening.
- Life expectancy < 3 months.
- Patient in other interventional clinical studies, who received live investigational product, including: Unlisted new drugs within 3 months before CNCT19 injection, marketed drug within 5 half-lives before CNCT19 injection, or who intend to participate in another clinical trial or receive anti-tumor therapy outside the protocol during the entire study.
- Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Beijing Boren Hospital
Beijing, Beijing Municipality, 100000
Chunrong Tong
- Recruiting
West China Hospital，Sichuan University
Chengdu, Sichuan, 610000
Ting Niu
- Recruiting
Xinqiao Hospital of TMMU
Chongqing, Chongqing Municipality, 400000
Xi Zhang
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong
Hongsheng Zhou
- Recruiting
The First Affiliated Hospital, Zhejiang University school of Medicine
Hangzhou, Zhejiang, 310000
Jie Jin
- Not yet recruiting
Yanda hospital, Hebei medical university
Sanhe, Hebei, 065200
Min Jiang
- Recruiting
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200000
Aibin Liang
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
Jianxiang Wang, Dr., +86-022-23909067, wangjx@ihcams.ac.cn
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
Heng Mei
- Recruiting
The affiliated hospital of Xuzhou medical university
Xuzhou, Jiangsu, 221006
Kailin Xu
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Xudong Wei
About this study
Official title: Phase Ⅱ Clinical Trial of CNCT19 Cell Injection in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia
The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.
Read the detailed description
The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period (8 weeks), treatment period (4 weeks), and follow-up period (2 years at most).
- Being tested
- single dose of CNCT19
- Medical subject headings
- Recurrence, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single dose of CNCT19Biological
Dose: 0.5 x 10^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Single dose of CNCT19 | Experimental | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19. Receives: Biological: single dose of CNCT19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) as determined by Independent Review Committee (IRC).
The Investigators' evaluation results of ORR will be subjected to sensitivity analysis.
Measured: At 3 months after infusion
Secondary outcomes (14)
Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow as determined by IRC and Investigators.
MRD negative status as determined using flow cytometry.
Measured: 3 months
Overall Remission Rate (ORR) as determined by IRC and Investigators.
The proportion of patients who have achieved CR or CRi.
Measured: 28 days
Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow as determined by IRC and Investigators.
MRD negative status as determined using flow cytometry.
Measured: 28 days
Relapse Free Survival (RFS) as determined by IRC and Investigators.
RFS means the duration from reaching the response CR or CRi to the first defined relapse, or death due to any cause, whichever comes first.
Measured: 2 years
Event free survival (EFS) as determined by IRC and Investigators.
EFS means duration from the CNCT19 Cell Injection infusion to death for any reason after remission, relapse, treatment failure, no response, or termination (because of death, adverse event, lack of efficacy, progression, new anti-tumor treatments.
Measured: 2 years
Duration of remission (DOR) as determined by IRC and Investigators.
DOR means the duration from reaching the response CR or CRi to the first defined relapse, or death due to any cause, whichever comes first.
Measured: 2 years
Best overall response (BOR) as determined by IRC and Investigators.
The proportion of patients who have achieved the best effect (CR or CRi) after the experimental treatment.
Measured: 2 years
Overall survival (OS) as determined by IRC and Investigators.
OS is defined as the time from the CNCT19 Cell Injection infusion to the date of death due to any cause.
Measured: 2 years
In vivo cellular Pharmacokinetic (PK) profile of CNCT19 in units of transgene copy number per genomic DNA (gDNA) amount.
Characterize the pharmacokinetic (PK) profile in blood, bone marrow (if available) and Cerebral Spinal Fluid (CSF) (if available) by qPCR.
Measured: 2 years
In vivo cellular Pharmacokinetic (PK) profile of CNCT19 in units of percent of CAR-positive cells.
Characterize the pharmacokinetic (PK) profile in blood, bone marrow (if available) and Cerebral Spinal Fluid (CSF) (if available) by Flow Cytometry.
Measured: 2 years
Concentration of Cytokines in Serum.
Collected as pharmacodynamic data, including IL-6 at list.
Measured: 28 days
Concentration of ferritin in Serum.
Collected as pharmacodynamic data.
Measured: 28 days
Concentration of C reactive protein in serum.
Collected as pharmacodynamic data.
Measured: 28 days
Prevalence and incidence of humoral immunogenicity (anti-drug antibodies) to CNCT19.
Collected as Immunogenicity data.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start24 Dec 2020
- Primary completion22 Sep 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Juventas Cell Therapy Ltd.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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juventas Cell Therapy Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianxiang Wang, Dr., Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684147
- Sponsor's protocol ID
- HY001201
- Status last verified
- Aug 2025
- First submitted
- 9 Dec 2020
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Lv L, Song Y, Wei X, Zhou H, Liu Q, Xu K, Yan D, Zhang C, Liu S, Jin J, Mei H, Niu T, Liang A, Gu R, Ren J, Feng Y, Jin W, Zhou Y, Deng Y, Wang J. Inaticabtagene autoleucel in adult relapsed or refractory B-cell acute lymphoblastic leukemia. Blood Adv. 2025 Feb 25;9(4):836-843. doi: 10.1182/bloodadvances.2024014182.
PubMed 39626300Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.
PubMed 35622074
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Clinical Trial of CNCT19 Cell Injection in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT04684147
- Acronym / sponsor ID
- HY001201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Juventas Cell Therapy Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Dec 2020 (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.
The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.
Detailed description
The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period (8 weeks), treatment period (4 weeks), and follow-up period (2 years at most).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose of CNCT19 | Experimental | Biological: single dose of CNCT19A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Informed consent is signed by the subject.
- Age 18 to 65.
- Relapsed or refractory acute lymphoblastic leukemia (ALL). (1) Relapse within 12 months of first remission; (2)a. Without remission after more than 6 weeks of induction chemotherapy or without remission after 2 cycles of induction chemotherapy regimen; c. 2nd or greater Bone Marrow (BM) relapse OR; d. First relapse after chemotherapy, without remission after at least 1 rescue treatment; e. Any BM relapse after autologous or allogeneic stem cell transplantation (SCT).
- Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months of study entry.
- Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 generation of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a T315I mutation.
Key exclusion criteria (34 listed)
- Active Central Nervous System (CNS) involvement by malignancy.
- Isolated extra-medullary disease relapse.
- Patients who received chemotherapy within 2 weeks before CNCT19 infusion. The following situations are excluded:
- Radiotherapy before CNCT19 infusion:
- Non-CNS site of radiation completed < 2 weeks prior to CNCT19 Infusion; CNS directed radiation completed < 8 weeks prior to CNCT19 infusion.
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 |
|---|---|---|
| single dose of CNCT19Dose: 0.5 x 10^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide | Biological | Single dose of CNCT19 |
Primary outcome
Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) as determined by Independent Review Committee (IRC).
Time frame: At 3 months after infusion
The Investigators' evaluation results of ORR will be subjected to sensitivity analysis.
14 secondary outcomes
Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow as determined by IRC and Investigators.
Time frame: 3 months
Overall Remission Rate (ORR) as determined by IRC and Investigators.
Time frame: 28 days
Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow as determined by IRC and Investigators.
Time frame: 28 days
Relapse Free Survival (RFS) as determined by IRC and Investigators.
Time frame: 2 years
Event free survival (EFS) as determined by IRC and Investigators.
Time frame: 2 years
Duration of remission (DOR) as determined by IRC and Investigators.
Time frame: 2 years
Best overall response (BOR) as determined by IRC and Investigators.
Time frame: 2 years
Overall survival (OS) as determined by IRC and Investigators.
Time frame: 2 years
In vivo cellular Pharmacokinetic (PK) profile of CNCT19 in units of transgene copy number per genomic DNA (gDNA) amount.
Time frame: 2 years
In vivo cellular Pharmacokinetic (PK) profile of CNCT19 in units of percent of CAR-positive cells.
Time frame: 2 years
Concentration of Cytokines in Serum.
Time frame: 28 days
Concentration of ferritin in Serum.
Time frame: 28 days
Concentration of C reactive protein in serum.
Time frame: 28 days
Prevalence and incidence of humoral immunogenicity (anti-drug antibodies) to CNCT19.
Time frame: 2 years
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 8 Aug 2025.
- Derived from this study: PubMed 39626300Wang Y, Lv L, Song Y, Wei X, Zhou H, Liu Q, Xu K, Yan D, Zhang C, Liu S, Jin J, Mei H, Niu T, Liang A, Gu R, Ren J, Feng Y, Jin W, Zhou Y, Deng Y, Wang J. Inaticabtagene autoleucel in adult relapsed or refractory B-cell acute lymphoblastic leukemia. Blood Adv. 2025 Feb 25;9(4):836-843. doi: 10.1182/bloodadvances.2024014182.
- Derived from this study: PubMed 35622074Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.
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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.
Jianxiang Wang, Dr. principal investigator
Institute of Hematology & Blood Diseases Hospital, China
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing single dose of CNCT19 in people with Relapsed or Refractory Acute Lymphoblastic Leukemia, run by Juventas Cell Therapy Ltd. at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 34 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: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Contact Yan Zhou (+86-15010390127, zhouyan@juventas.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) as determined by Independent Review Committee (IRC). (time frame: At 3 months after infusion). 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 NCT04684147, which also lists 2 linked publications.
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 8 Aug 2025.