T-Cell Acute Lymphocytic LeukemiaPhase 1/2nanobody CD5NCT07070323
A Multicenter, Open-Label, Non-Randomized, Single-Arm Clinical Study of Nanobody CD5-CAR T Cell Therapy for Refractory/Relapsed T Lymphocyte Malignancies
A Phase 1/2 study testing Autologous CD5 CAR T-cells, Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells and Newly matched donor-derived CD5 CAR T-cells in people with T-Cell Acute Lymphocytic Leukemia and Acute Lymphoblastic Leukemia, in Relapse, run by Beijing GoBroad Hospital at 4 sites in China.
Trial summary
This is a multi-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10^6 (±20%) to dose… Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- T-Cell Acute Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoblastic Leukemia
- What is being tested?
- Autologous CD5 CAR T-cells, Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells and Newly matched donor-derived CD5 CAR T-cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesChina
- Study dates
- 9 Jul 2025to 31 Dec 2026
- 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Only patients who meet all the following criteria can be included:
- 1. Candidates with relapse or refractory CD5+ T-cell malignancies, who have progressed after treatment with all standard therapies or been intolerant of standard care, have limited prognosis with currently available therapies and have no available curative treatment options (such as stem-cell transplantation (SCT) or chemotherapy); 2. For subjects who received autologous CD5 CAR T cells, the tumor burden in peripheral blood is less than 20%, and suspending anti-neoplastic treatment for more than 2 weeks; 3. Aged 1-70 years; 4. No severe allergy; 5. Eastern Cooperative Oncology Group (ECOG) performance status 1 score 0 to 2; 6. Patients are expected to live for at least 60 days; 7. CD5+ on blasts in bone marrow (BM) or cerebrospinal fluid (CSF) and tumor tissues by flow cytometry and immunohistochemistry, respectively. (Positive rate >80% by flow cytometry with less than one log difference in mean fluorescence intensity from normal T cells, or positive rate >30% positive by immunohistochemistry); 8. Provide a signed informed consent before any screening procedure. Subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. Children candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form and their legal guardian or patient advocate has also need to sign the treatment consent form and voluntary consent form, respectively. Children candidates of 1-7 can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form; 9. Have available allogeneic hematopoietic stem cell transplantation donor for the subject who received newly matched donor-derived CD5 CAR T cells, and is willing to perform SCT when CR is achieved.
- -
Who cannot join
- Patients with at least one of the following conditions are excluded:
- 1. Impaired consciousness or intracranial hypertension; 2. Symptomatic congestive heart failure or severe cardiac arrhythmia; 3. Manifestations of severe respiratory system failure; 4. Co-existence with other malignancies; 5. Disseminated intravascular coagulation; 6. Serum creatinine and/or blood urea nitrogen (BUN) ≥ 1.5-fold upper limit; 7. Sepsis or other uncontrollable infections; 8. Uncontrollable diabetes; 9. Serious mental illness; 10. Apparent and active intracranial lesions on cranial magnetic resonance imaging (MRI); 11. Underwent organ transplantation, excepting SCT; 12. Pregnant females; 13. Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS) or syphilis; 14. Post-CAR SCT is not feasible in patients who plan to receive newly matched donor-derived CD5 CAR T cells; 15. Inability to collect peripheral blood mononuclear cells (PBMC) or no frozen PBMC available for CAR T cell manufacturing.
- -
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102206
- Not yet recruiting
The General Hospital of Western Theater Command PLA
Chengdu, Sichuan, 610083
- Recruiting
Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai
Shanghai, Shanghai Municipality, 200435
- Recruiting
Shanghai Liquan Hospital
Shanghai, Shanghai Municipality, 201418
About this study
This is a multi-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10^6 (±20%) to dose level 2: 2×10^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10^5 (±20%) /kg. The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1, the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in phase 2. A total number of 54 subjects will be enrolled.
Read the detailed description
详细描述
- Conditions
- T-Cell Acute Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoblastic Leukemia, T-cell Malignancies
- Being tested
- Autologous CD5 CAR T-cells, Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells, Newly matched donor-derived CD5 CAR T-cells
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous CD5 CAR T-cellsDrug
Peripheral blood mononuclear cells for the production of CD5 CAR T-cells from patients.
Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cellsDrug
Peripheral blood mononuclear cells for the production of CD5 CAR T cells are collected from previous SCT donors.
Newly matched donor-derived CD5 CAR T-cellsDrug
Peripheral blood mononuclear cells for the production of CD5 CAR T cells are collected from newly matched donors.
| Study group | Role | What they receive |
|---|---|---|
| Autologous CD5 CAR T-cells | Experimental | After a lymphodepleting regimen, the patients will receive autologous CD5 CAR T-cell infusion. Receives: Drug: Autologous CD5 CAR T-cells |
| Prior stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells | Experimental | After a lymphodepleting regimen, the patients will receive prior SCT donor-derived CD5 CAR T-cell infusion. Receives: Drug: Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells |
| Newly matched donor-derived CD5 CAR T-cells | Experimental | After a lymphodepleting regimen, the patients will receive newly matched donor-derived CD5 CAR T-cell infusion Receives: Drug: Newly matched donor-derived CD5 CAR T-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1-The incidence and type of dose-limiting toxicity (DLT)
The number of patients experiencing dose-limiting toxicity (DLT) will be evaluated and the type of DLT will be recorded.
Measured: 28 days after CD5 CAR T cell infusion
Phase 1-The incidence and severity of adverse events (AEs)
The number of patients experiencing adverse events (AEs) and the severity of AEs will be evaluated.
Measured: 30 days after CD5 CAR T cell infusion
Phase 2-Antitumor effect
Assessment of best overall response (BOR) rate. BOR rate is the percentage of patients with the best overall response in complete response (CR), complete response with incomplete hematological recovery (CRi) or partial response (PR) based on the National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia.
Measured: 3 months (± 1 week) after CD5 CAR T infusion
Secondary outcomes (8)
Phase 1-Objective response rate (ORR)
Objective response rate (ORR) is the percentage of subjects who have achieved CR, CRi or PR based on the National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia.
Measured: 30 days after CD5 CAR T cell infusion
Phase 1-Pharmacokinetics of CD5 CAR T cells
The proliferation and survival of CAR T cells will be measured by flow cytometry and quantitative polymerase chain reaction (qPCR).
Measured: Up to 2 years after CD5 CAR T cell infusion
Phase 1-The incidence and severity of adverse events (AEs).
The number of patients experiencing adverse events (AEs) and the severity of AEs will be evaluated.
Measured: From 30 days to 2 years after CD5 CAR T cell infusion
Phase 1-Best overall response (BOR) rate.
BOR rate is the percentage of patients with the best overall response in CR, CRi or PR based on the National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia.
Measured: 3 months (± 1 week) after CD5 CAR T cell infusion
Phase 2-Objective response rate (ORR)
Objective response rate (ORR) is the percentage of subjects who have achieved CR, CRi or PR based on the National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia.
Measured: 1 months and 3 months after CD5 CAR T cell infusion
Phase 2- The incidence and severity of AEs
The number of patients experiencing adverse events (AEs) and the severity of AEs will be evaluated.
Measured: Up to 2 years
Phase 2- Progression free survival (PFS)
Progression-free survival (PFS) is defined as the time from the initial CD5 CAR T cell infusion to the date of progression or death for any cause.
Measured: Up to 2 years
Phase 2- Overall survival (OS).
Overall survival (OS) is defined the time from the initial CD5 CAR T cell infusion to death for any cause.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start9 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Cell Acute Lymphocytic 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The General Hospital of Western Theater Command, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, Shanghai Liquan Hospital, Central People's Hospital of Zhanjiang, First Affiliated Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Jing Pan, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070323
- Sponsor's protocol ID
- BJGBYY-IIT-LCYJ-2025-049
- Acronym
- nanobody CD5
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Non-Randomized, Single-Arm Clinical Study of Nanobody CD5-CAR T Cell Therapy for Refractory/Relapsed T Lymphocyte Malignancies
- ClinicalTrials.gov ID
- NCT07070323
- Acronym / sponsor ID
- nanobody CD5 / BJGBYY-IIT-LCYJ-2025-049
- Conditions
- T-Cell Acute Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoblastic Leukemia, T-cell Malignancies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Collaborators
- The General Hospital of Western Theater Command, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, Shanghai Liquan Hospital, Central People's Hospital of Zhanjiang, First Affiliated Hospital of Guangxi Medical University
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jul 2025 (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 multi-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10^6 (±20%) to dose level 2: 2×10^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10^5 (±20%) /kg. The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1, the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in phase 2. A total number of 54 subjects will be enrolled.
Detailed description
详细描述
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autologous CD5 CAR T-cells | Experimental | Drug: Autologous CD5 CAR T-cellsAfter a lymphodepleting regimen, the patients will receive autologous CD5 CAR T-cell infusion. |
| Prior stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells | Experimental | Drug: Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cellsAfter a lymphodepleting regimen, the patients will receive prior SCT donor-derived CD5 CAR T-cell infusion. |
| Newly matched donor-derived CD5 CAR T-cells | Experimental | Drug: Newly matched donor-derived CD5 CAR T-cellsAfter a lymphodepleting regimen, the patients will receive newly matched donor-derived CD5 CAR T-cell infusion |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Candidates with relapse or refractory CD5+ T-cell malignancies, who have progressed after treatment with all standard therapies or been intolerant of standard care, have limited prognosis with currently available therapies and have no available curative treatment options (such as stem-cell transplantation (SCT) or chemotherapy); 2. For subjects who received autologous CD5 CAR T cells, the tumor burden in peripheral blood is less than 20%, and suspending anti-neoplastic treatment for more than 2 weeks; 3. Aged 1-70 years; 4. No severe allergy; 5. Eastern Cooperative Oncology Group (ECOG) performance status 1 score 0 to 2; 6. Patients are expected to live for at least 60 days; 7. CD5+ on blasts in bone marrow (BM) or cerebrospinal fluid (CSF) and tumor tissues by flow cytometry and immunohistochemistry, respectively. (Positive rate >80% by flow cytometry with less than one log difference in mean fluorescence intensity from normal T cells, or positive rate >30% positive by immunohistochemistry); 8. Provide a signed informed consent before any screening procedure. Subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. Children candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form and their legal guardian or patient advocate has also need to sign the treatment consent form and voluntary consent form, respectively. Children candidates of 1-7 can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form; 9. Have available allogeneic hematopoietic stem cell transplantation donor for the subject who received newly matched donor-derived CD5 CAR T cells, and is willing to perform SCT when CR is achieved.
- -
Key exclusion criteria (3 listed)
- 1. Impaired consciousness or intracranial hypertension; 2. Symptomatic congestive heart failure or severe cardiac arrhythmia; 3. Manifestations of severe respiratory system failure; 4. Co-existence with other malignancies; 5. Disseminated intravascular coagulation; 6. Serum creatinine and/or blood urea nitrogen (BUN) ≥ 1.5-fold upper limit; 7. Sepsis or other uncontrollable infections; 8. Uncontrollable diabetes; 9. Serious mental illness; 10. Apparent and active intracranial lesions on cranial magnetic resonance imaging (MRI); 11. Underwent organ transplantation, excepting SCT; 12. Pregnant females; 13. Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS) or syphilis; 14. Post-CAR SCT is not feasible in patients who plan to receive newly matched donor-derived CD5 CAR T cells; 15. Inability to collect peripheral blood mononuclear cells (PBMC) or no frozen PBMC available for CAR T cell manufacturing.
- -
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 |
|---|---|---|
| Autologous CD5 CAR T-cellsPeripheral blood mononuclear cells for the production of CD5 CAR T-cells from patients. | Drug | Autologous CD5 CAR T-cells |
| Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cellsPeripheral blood mononuclear cells for the production of CD5 CAR T cells are collected from previous SCT donors. | Drug | Prior stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells |
| Newly matched donor-derived CD5 CAR T-cellsPeripheral blood mononuclear cells for the production of CD5 CAR T cells are collected from newly matched donors. | Drug | Newly matched donor-derived CD5 CAR T-cells |
Primary outcome
Phase 1-The incidence and type of dose-limiting toxicity (DLT)
Time frame: 28 days after CD5 CAR T cell infusion
The number of patients experiencing dose-limiting toxicity (DLT) will be evaluated and the type of DLT will be recorded.
Phase 1-The incidence and severity of adverse events (AEs)
Time frame: 30 days after CD5 CAR T cell infusion
The number of patients experiencing adverse events (AEs) and the severity of AEs will be evaluated.
Phase 2-Antitumor effect
Time frame: 3 months (± 1 week) after CD5 CAR T infusion
Assessment of best overall response (BOR) rate. BOR rate is the percentage of patients with the best overall response in complete response (CR), complete response with incomplete hematological recovery (CRi) or partial response (PR) based on the National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia.
8 secondary outcomes
Phase 1-Objective response rate (ORR)
Time frame: 30 days after CD5 CAR T cell infusion
Phase 1-Pharmacokinetics of CD5 CAR T cells
Time frame: Up to 2 years after CD5 CAR T cell infusion
Phase 1-The incidence and severity of adverse events (AEs).
Time frame: From 30 days to 2 years after CD5 CAR T cell infusion
Phase 1-Best overall response (BOR) rate.
Time frame: 3 months (± 1 week) after CD5 CAR T cell infusion
Phase 2-Objective response rate (ORR)
Time frame: 1 months and 3 months after CD5 CAR T cell infusion
Phase 2- The incidence and severity of AEs
Time frame: Up to 2 years
Phase 2- Progression free survival (PFS)
Time frame: Up to 2 years
Phase 2- Overall survival (OS).
Time frame: Up to 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 26 Nov 2025.
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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.
4 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 Autologous CD5 CAR T-cells, Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells and Newly matched donor-derived CD5 CAR T-cells in people with T-Cell Acute Lymphocytic Leukemia and Acute Lymphoblastic Leukemia, in Relapse, run by Beijing GoBroad Hospital at 4 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 3 inclusion and 3 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 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Shaocong Miao (86+18831006667, miaosc@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1-The incidence and type of dose-limiting toxicity (DLT) (time frame: 28 days after CD5 CAR T cell infusion). The study lists 3 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 26 Nov 2025.