B-cell Acute Lymphoblastic LeukemiaPhase 1/2NCT06580301
Study of YK012 in B-cell Acute Lymphoblastic Leukemia
A Phase 1/2 study testing YK012 in people with B-cell Acute Lymphoblastic Leukemia, run by Excyte Biopharma Ltd at 12 sites in China.
Trial summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YK012 administered as monotherapy in participants with B-cell acute lymphoblastic leukemia (B-ALL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- YK012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 12 sitesChina
- Study dates
- 25 Sep 2024to 30 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study.
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
- An estimated survival time of more than 12 weeks.
- A definitive diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with any of the following conditions:
- Ph-negative B-ALL with any of the following: i. Failure to achieve complete remission after initial induction therapy. ii. Failure to achieve complete remission after salvage treatment. iii. Relapse with first remission duration ≤12 months. iv. Second or later relapse. v. Relapse after hematopoietic stem cell transplantation (HSCT).
- Ph-positive B-ALL: failure to 1 or more tyrosine kinase inhibitors (TKIs), or intolerance to treatment with TKIs, or with the T315I mutation.
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- ≥ 5% blasts in the bone marrow by morphologic assessment.
- Recovery to Grade 0-1 (Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0) from adverse events related to prior therapy except alopecia.
- Adequate hematological and organ function.
- Female participants of childbearing potential must have a negative serum pregnancy test at screening. Female patients who are sexually active must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
- Male participants must agree to use reliable methods of contraception (barrier methods or sexual abstinence) and avoid sperm donation throughout the study period and until 3 months after the last dose.
Who cannot join
- Burkitt´s Leukemia according to World Health Organization (WHO) classification.
- History of antitumor therapy as follows, before the first dose of study drug:
- Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer
- Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 3 weeks
- Radiotherapy or chemotherapy (except for intrathecal chemotherapy and dexamethasone), or treatment with Chinese traditional/patent medicine that has definite antitumor effect within 2 weeks
- Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter
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- Receipt of any live attenuated vaccines or live virus vaccine within 4 weeks
- Autologous stem cell transplantation within 6 weeks
- History of organ transplant, or allogeneic stem cell transplantation within 12 weeks.
- Any active acute graft-versus-host disease (GvHD), grade 2-4 (according to Glucksberg criteria) or active chronic GvHD requiring systemic treatment.
- Other malignancy within 5 years, except localized malignancies that have been adequately treated or free of the disease for ≥ 5 years, e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-muscle invasive bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast.
- Active central nervous system (CNS) involvement or meningeal involvement with clinical signs, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the investigator.
- a. History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis. b. Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI.
- History or evidence of cardiovascular disease, including:
- Acute coronary syndromes (e.g., myocardial infarction, unstable angina)
- Coronary angioplasty or stenting within 6 months prior to enrollment
- Clinically significant unstable arrhythmias (e.g., atrial fibrillation), however, atrial fibrillation has been controlled for over 30 days prior to the first dose of YK012 were allowed
- New York Heart Association (NYHA) stage III or higher congestive heart failure
- Left ventricular ejection fraction (LVEF) below lower limit of the study center, or LVEF<50% if there is no lower limit at the study center
- The Fridericia-corrected QT interval (QTcF, mean of triplicate measurements) ≥ 470 msec (female) or ≥ 450 msec (male)
- Implantable defibrillator
- Clinically uncontrollable hypertension (i.e., SBP≥160 mm Hg and/or DBP≥100 mm Hg).
- Known allergy to monoclonal antibody drugs or exogenous immunoglobulin.
- History of CD19 targeted therapy and positive test result for immunogenicity of YK012 at screening.
- Any major organ surgery or significant trauma within 4 weeks prior to the first dose of YK012, or those requiring elective surgeries during the study, and all AEs associated with surgery or significant trauma have not recovered to Grade ≤1 or baseline graded by CTCAE v5.0 before the first dose of the YK012.
- Regular dose of systemic corticosteroids during 4 weeks prior to initiation of study drug, or anticipated need of corticosteroids exceeding prednisone 20 mg/day or equivalent during the trial, or any other immunosuppressive therapy within 4 weeks prior to study entry.
- Virological tests: Hepatitis B virus surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) deoxyribonucleic acid (DNA)>ULN of the testing agency; Hepatitis C antibody (HCV-Ab) positive and hepatitis C virus-RNA (HCV-RNA)>ULN of the testing agency; Anti-human immunodeficiency virus (Anti-HIV) positive. Participants will be excluded from the study if any of the above criteria is met.
- Uncontrolled active infections requiring oral or intravenous systemic therapy, except for local treatment.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently).
- Pregnant or lactating women.
- Known mental disorder that may affect study compliance or poor compliance.
- Other serious systemic diseases or laboratory abnormalities or other reasons that the investigator believes are not appropriate for participating in the study.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Sujun Gao, MD
- Recruiting
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
Meiyun Fang, MD
Xiang Li
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000
Danian Nie
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Yang Liang, MD
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Peilong Lai, MD
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Jishi Wang, MD
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jie Jin, MD, +86-0571-87236898, jiej0503@163.com
- Recruiting
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650033
Zeping Zhou, MD
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Fei Li, MD
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000
Wei Yang, MD
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Zhenyu Li, MD
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Zunmin Zhu, MD
About this study
Official title: An Open-Label, Multi-Center, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YK012 in Participants With B-cell Acute Lymphoblastic Leukemia
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YK012 administered as monotherapy in participants with B-cell acute lymphoblastic leukemia (B-ALL).
Read the detailed description
YK012 is a bispecific antibody designed to link B cells and T cells resulting in T-cell activation and a cytotoxic T-cell response against cluster of differentiation (CD)19 expressing cells. Relapsed/refractory B-ALL in adult patients is an aggressive malignant disease with dismal prognosis. This study is designed in 2 parts as described below: Phase Ib (dose escalation) and Phase II (dose expansion). If in Phase Ib it is observed in adult subjects at doses with manageable risk and antitumor activity, studies in pediatric subjects can be initiated to explore safety and efficacy in pediatric subjects, as well as pharmacokinetic profiles.
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- YK012
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YK012Drug
Also called YK012 for Injection
The treatments include 2 cycles of induction treatment, 3 cycles of consolidation treatment, and up to 5 cycles of maintenance treatment.
| Study group | Role | What they receive |
|---|---|---|
| YK012 | Experimental | Participants will be assigned to a dose level of YK012 based on when the participants join this study.
Participants will receive YK012 by intravenous infusion (IV), once per week, four weeks per treatment cycle. Receives: Drug: YK012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence and Profile of Dose-limiting Toxicity (DLT)
The toxicities occurring within 28 days (i.e., DLT observation period) after the first dose will be defined as DLTs in the discretion of the investigator as related to the IMP (Investigational Medicinal Product).
This outcome measure is applicable for dose escalation phase only. The MTD dose will be calculated by the statistician upon completion of the dose escalation study.
Measured: 28 days after the first dose
Maximum Tolerated dose (MTD) or The Recommended Dose for Future Clinical Study
This outcome measure is applicable for dose escalation phase only. The MTD dose will be calculated by the statistician upon completion of the dose escalation study.
Measured: Through study completion, 20 weeks
Number of Participants with Adverse Events
An AE is defined as any untoward medical event that occurs after a subject receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.
Measured: From the time the participant signs the ICF until the end of the safety visit period, assessed up to 24weeks.
Number of Participants with Serious Adverse Events
An SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the subject receives the IMP, and congenital abnormalities or birth defects.
Measured: From the time the participant signs the ICF until the end of the safety visit period, assessed up to 24weeks.
Dose Expansion Phase: Objective Response Rate (ORR)
ORR is defined as percentage of participants achieving either a complete response (CR) or complete remission with partial hematological recovery (CRi).
The MTD dose will be calculated by the statistician upon completion of the dose escalation study.
This outcome measure is applicable for dose expansion phase only.
Measured: From the time the participant signs the ICF until hematological relapse, assessed up to 1 year
Secondary outcomes (11)
Area Under the Concentration-time Curve (AUC)
The PK (AUC) of YK012 will be evaluated.
Measured: Up to 20 weeks
Maximum Observed Concentration (Cmax)
The PK (Cmax) of YK012 will be evaluated.
Measured: Up to 20 weeks
Time to Reach Maximum Concentration (Tmax)
The PK (Tmax) of YK012 will be evaluated.
Measured: Up to 20 weeks
Half Life (t1/2) of YK012
The PK (t1/2) of YK012 will be evaluated.
Measured: Up to 20 weeks
Clearance (CL) of YK012
The PK (CL) of YK012 will be evaluated.
Measured: Up to 20 weeks
Trough Plasma Concentration (Ctrough)
The PK (Ctrough) of YK012 will be evaluated.
Measured: Up to 20 weeks
Percentage of Participants with Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) Against YK012
Assess the percentage of participants with ADA and Nab (only assessed when ADA positive except for the screening period) after treatment with YK012.
Measured: Up to 20 weeks
Dose Escalation Phase: Objective Response Rate (ORR)
ORR is defined as percentage of participants achieving either a complete response (CR) or complete remission with partial hematological recovery (CRi).
The MTD dose will be calculated by the statistician upon completion of the dose escalation study.
This outcome measure is applicable for dose escalation phase only.
Measured: From the time the participant signs the ICF until hematological relapse, assessed up to 1 year
Relapse-free Survival (RFS)
RFS was measured from first dose of YK012 until the first assessment of documented relapse, or death due to any cause, whichever occurs first including the time after the transplant.
Measured: From the time the participant signs the ICF until hematological relapse, assessed up to 1 year
Overall survival (OS)
Overall survival was measured from the first treatment with YK012 until death due to any cause. Participants who did not die were censored at their last contact date.
Measured: From the date of first dose until loss of follow-up, death, withdrawal of informed consent, or the end of study, whichever occurs first, assessed up to 1 year.
Number of B cells and T cells in peripheral blood after administration
Assess the number of B cells and T cells in peripheral blood after treatment with YK012
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start25 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Excyte Biopharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Jin, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580301
- Sponsor's protocol ID
- YK012-2
- Status last verified
- Feb 2026
- First submitted
- 26 Aug 2024
- Last updated
- 6 Feb 2026
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YK012 in Participants With B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06580301
- Acronym / sponsor ID
- YK012-2
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Excyte Biopharma LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YK012 administered as monotherapy in participants with B-cell acute lymphoblastic leukemia (B-ALL).
Detailed description
YK012 is a bispecific antibody designed to link B cells and T cells resulting in T-cell activation and a cytotoxic T-cell response against cluster of differentiation (CD)19 expressing cells. Relapsed/refractory B-ALL in adult patients is an aggressive malignant disease with dismal prognosis. This study is designed in 2 parts as described below: Phase Ib (dose escalation) and Phase II (dose expansion). If in Phase Ib it is observed in adult subjects at doses with manageable risk and antitumor activity, studies in pediatric subjects can be initiated to explore safety and efficacy in pediatric subjects, as well as pharmacokinetic profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YK012 | Experimental | Drug: YK012Participants will be assigned to a dose level of YK012 based on when the participants join this study. Participants will receive YK012 by intravenous infusion (IV), once per week, four weeks per treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study.
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
- An estimated survival time of more than 12 weeks.
- A definitive diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with any of the following conditions:
- ≥ 5% blasts in the bone marrow by morphologic assessment.
Key exclusion criteria (32 listed)
- Burkitt´s Leukemia according to World Health Organization (WHO) classification.
- History of antitumor therapy as follows, before the first dose of study drug:
- Any active acute graft-versus-host disease (GvHD), grade 2-4 (according to Glucksberg criteria) or active chronic GvHD requiring systemic treatment.
- Other malignancy within 5 years, except localized malignancies that have been adequately treated or free of the disease for ≥ 5 years, e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-muscle invasive bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast.
- Active central nervous system (CNS) involvement or meningeal involvement with clinical signs, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the investigator.
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 |
|---|---|---|
| YK012Also: YK012 for InjectionThe treatments include 2 cycles of induction treatment, 3 cycles of consolidation treatment, and up to 5 cycles of maintenance treatment. | Drug | YK012 |
Primary outcome
The Incidence and Profile of Dose-limiting Toxicity (DLT)
Time frame: 28 days after the first dose
The toxicities occurring within 28 days (i.e., DLT observation period) after the first dose will be defined as DLTs in the discretion of the investigator as related to the IMP (Investigational Medicinal Product). This outcome measure is applicable for dose escalation phase only. The MTD dose will be calculated by the statistician upon completion of the dose escalation study.
Maximum Tolerated dose (MTD) or The Recommended Dose for Future Clinical Study
Time frame: Through study completion, 20 weeks
This outcome measure is applicable for dose escalation phase only. The MTD dose will be calculated by the statistician upon completion of the dose escalation study.
Number of Participants with Adverse Events
Time frame: From the time the participant signs the ICF until the end of the safety visit period, assessed up to 24weeks.
An AE is defined as any untoward medical event that occurs after a subject receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.
Number of Participants with Serious Adverse Events
Time frame: From the time the participant signs the ICF until the end of the safety visit period, assessed up to 24weeks.
An SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the subject receives the IMP, and congenital abnormalities or birth defects.
Dose Expansion Phase: Objective Response Rate (ORR)
Time frame: From the time the participant signs the ICF until hematological relapse, assessed up to 1 year
ORR is defined as percentage of participants achieving either a complete response (CR) or complete remission with partial hematological recovery (CRi). The MTD dose will be calculated by the statistician upon completion of the dose escalation study. This outcome measure is applicable for dose expansion phase only.
11 secondary outcomes
Area Under the Concentration-time Curve (AUC)
Time frame: Up to 20 weeks
Maximum Observed Concentration (Cmax)
Time frame: Up to 20 weeks
Time to Reach Maximum Concentration (Tmax)
Time frame: Up to 20 weeks
Half Life (t1/2) of YK012
Time frame: Up to 20 weeks
Clearance (CL) of YK012
Time frame: Up to 20 weeks
Trough Plasma Concentration (Ctrough)
Time frame: Up to 20 weeks
Percentage of Participants with Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) Against YK012
Time frame: Up to 20 weeks
Dose Escalation Phase: Objective Response Rate (ORR)
Time frame: From the time the participant signs the ICF until hematological relapse, assessed up to 1 year
Relapse-free Survival (RFS)
Time frame: From the time the participant signs the ICF until hematological relapse, assessed up to 1 year
Overall survival (OS)
Time frame: From the date of first dose until loss of follow-up, death, withdrawal of informed consent, or the end of study, whichever occurs first, assessed up to 1 year.
Number of B cells and T cells in peripheral blood after administration
Time frame: Up to 20 weeks
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 6 Feb 2026.
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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.
Jie Jin, MD principal investigator
First Affiliated Hospital of Zhejiang University
12 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 YK012 in people with B-cell Acute Lymphoblastic Leukemia, run by Excyte Biopharma Ltd at 12 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 11 inclusion and 32 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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Jin, MD (+86-0571-87236898, jiej0503@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence and Profile of Dose-limiting Toxicity (DLT) (time frame: 28 days after the first dose). 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 6 Feb 2026.