Relapsed Pediatric ALLPhase 1NCT07257419
CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
A Phase 1 study testing Anti-Thymocyte Globulin (Rabbit), Cyclophosphamide and Fludarabine in people with Relapsed Pediatric ALL and Hematopoietic Cell Transplantation, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Relapsed Pediatric ALL, Hematopoietic Cell Transplantation, Hematologic Malignancy
- What is being tested?
- Anti-Thymocyte Globulin (Rabbit), Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2026to Dec 2035
- Phase
- Phase 1
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Recipient
- Age less than or equal to 21 years
- High risk hematologic malignancy where allogeneic transplantation is the current standard of care. This includes (but is not limited to):
- High risk CD19+ B cell ALL in CR1 or CR2
- Any CD19+ B-cell ALL in CR3 or subsequent
- If prior CNS leukemia, it must be treated and in CNS CR
Show all 20Show fewer
- Left ventricular ejection fraction > 40%, or shortening fraction ≥ 25%
- Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml/min/1.73m2
- Forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing
- Karnofsky or Lansky (age dependent) performance score ≥ 50 (See APPENDIX A)
- Bilirubin ≤ 3 times the upper limit of normal for age
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age
- Donor
- At least single haplotype matched (≥ 4 of 8) family member
- At least 18 years of age
- HIV negative
- If sexually active, agreement to use birth control until 2 weeks after completion of the mobilization and apheresis procedure
- Regarding donation eligibility, is identified as either:
- Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR
- Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271
Who cannot join
- Recipient
- Has a suitable HLA-identical sibling or suitable 12/12 (HLA-A, B, C, DRB1, DQB1, and DPB1) HLA-matched unrelated donor available in an appropriate time frame
- Any other active malignancy other than the one for which this HCT is indicated
- Received a prior allogeneic HCT at any time
- Pregnant, if female is of childbearing potential, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment
- If sexually active, agreement to use birth control until 6 months after T cell infusion
Show all 11Show fewer
- Breast feeding
- Any severe current uncontrolled bacterial, fungal or viral infection
- Donor
- Pregnant, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment if female
- If female, breast feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Swati Naik, MBBS, 888-226-4343, referralinfo@stjude.org
Swati Naik, MBBS
About this study
The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL.
Primary Objective:
- To assess the safety and feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.
Secondary Objectives:
- To estimate 1-year post-transplant overall survival, event-free survival, and GVHD-free relapse-free survival (GRFS).
- To estimate cumulative incidence of engraftment, acute and chronic GVHD, and immune-related adverse events, including CRS and ICANS.
Read the detailed description
This is a Phase I study evaluating the addback of CD19-CAR(Mem) T cells after TCRαβ+/CD19 B cell depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.
Donors that meet eligibility criteria will be consented to undergo two separate collections: 1) G-CSF mobilized stem cell graft via apheresis for progenitor cell infusion and 2) Non-mobilized peripheral blood mononuclear cells (PBMC) via apheresis for subsequent CAR T-cell manufacturing and DLI if needed.
Patients that meet eligibility criteria to receive therapy will be consented to proceed on study. Treatment will include a conditioning chemotherapy preparative regimen followed by infusion of TCRαβ/CD19 B cell depleted progenitor cell infusion on day 0. Then as early as day + 14 patients will receive the previously manufactured CD19-CAR(Mem) T cell product. Patients will then be monitored for safety and efficacy of the infused CAR T-cell product, as well as collection of correlative samples.
- Being tested
- Anti-Thymocyte Globulin (Rabbit), Cyclophosphamide, Fludarabine, Thiotepa, Mesna
- Keywords
- Relapsed/Refractory ALL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Hematologic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Thymocyte Globulin (Rabbit)Drug
Days -10, -11, -12.
CyclophosphamideDrug
60 mg/kg intravenous once daily on day -9.
FludarabineDrug
30 mg/m2 intravenous once daily for >10 kg, 1 mg/kg intravenous once daily for ≤10 kg on days -4, -5, -6, -7, -8.
ThiotepaDrug
5 mg/kg intravenous twice daily on day -3.
MesnaDrug
Mesna is planned to be administered at 15 mg/kg/dose prior to cyclophosphamide and at approximately 3, 6, and 9 hours after the cyclophosphamide infusion, to give a 1:1 ratio of mesna:cyclophosphamide.
MelphalanDrug
70 mg/m2 intravenous once daily for >10 kg, 2.3 mg/kg intravenous once daily for ≤10 kg on days -1, and -2.
FilgrastimDrug
Also called G-CSF
G-CSF* 10 mcg/kg/day SC days 0, -1, -2, -3, -4, -5.
CliniMACS SystemDevice
The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.
| Study group | Role | What they receive |
|---|---|---|
| HAPALL Treatment | Experimental | Patients receive a conditioning regimen that will comprise of ATG, Fludarabine, Cyclophosphamide. Melphalan and Thiotepa. Following the conditioning regimen, patients receive infusion of TCRαβ+/CD19 B cell depleted progenitor cell infusion on day 0. Then as early as day + 14 patients will receive the previously manufactured CD19-CAR(Mem) T cell product. Patients will then be monitored for safety and efficacy of the infused CAR T-cell product,
Cells for infusion are prepared using the CliniMACS system. Receives: Drug: Anti-Thymocyte Globulin (Rabbit); Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Thiotepa; Drug: Mesna; Drug: Melphalan; Drug: Filgrastim; Device: CliniMACS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.
The primary analysis will compute the sample proportions and corresponding binomial exact 95% confidence intervals among evaluable patients for the following toxicities (separately for each toxicity) within 100 days post-HCT: 1) Severe aGVHD defined as Grade 3-4 aGVHD 2) Severe CRS defined as Grade 4 CRS that does not resolve to grade 3 or lower within 72 hours of onset 3) Severe ICANS defined as Grade 4 ICANS that does not resolve to grade 3 or lower within 72 hours of onset 4) TRM defined as death without prior relapse or disease progression within 100 days post-HCT 5) Other toxicity data will also be reported for a complete safety assessment of the study regimen.
Measured: This will be assessed 100 days post-HCT
To assess the feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.
this will be measured by the failure to receive CD19-CAR(Mem) T cells among patients who received HCT. The number of patients who fail to receive addback will be reported as the proportion who were unable to receive addback within 60 days post-HCT
Measured: This will be assessed in the first 60 days post-HCT
Secondary outcomes (6)
To assess the feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.
This will be measured by the failure to receive CD19-CAR(Mem) T cells among patients who received HCT. The number of patients who fail to receive addback will be reported as the proportion who were unable to receive addback within 60 days post-HCT
Measured: This will be assessed in the first 60 days post-HCT
Estimate 1-year post-transplant relapse free survival
This this will be estimated by the Kaplan-Meier method
Measured: This will be assessed in the first 3 years post-HCT
Estimate cumulative incidence of neutrophil engraftment
This will be summarized by cumulative incidence functions estimated by the Kalbfleisch-Prentice method.
Measured: This will be assessed in the first 30 days post-HCT
Estimate cumulative incidence of platelet engraftment
This will be summarized by cumulative incidence functions estimated by the Kalbfleisch-Prentice method.
Measured: This will be assessed in the first 100 days post-HCT
Estimate cumulative incidence of acute and chronic GVHD
This will be summarized by cumulative incidence functions estimated by the Kalbfleisch-Prentice method.
Measured: This will be assessed in the first 3 years post-HCT
Estimate cumulative incidence of immune-related adverse events
This will be summarized by cumulative incidence functions estimated by the Kalbfleisch-Prentice method.
Measured: This will be assessed in the first 1 years post-HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start3 Oct 2026 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Pediatric ALLStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Swati Naik, MBBS, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257419
- Sponsor's protocol ID
- HAPALL
- Other IDs
- NCI-2025-08364
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
- ClinicalTrials.gov ID
- NCT07257419
- Acronym / sponsor ID
- HAPALL
- Keywords
- Relapsed/Refractory ALL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 3 Oct 2026 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 2 Dec 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.
The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL.
Primary Objective:
- To assess the safety and feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.
Secondary Objectives:
- To estimate 1-year post-transplant overall survival, event-free survival, and GVHD-free relapse-free survival (GRFS).
- To estimate cumulative incidence of engraftment, acute and chronic GVHD, and immune-related adverse events, including CRS and ICANS.
Detailed description
This is a Phase I study evaluating the addback of CD19-CAR(Mem) T cells after TCRαβ+/CD19 B cell depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.
Donors that meet eligibility criteria will be consented to undergo two separate collections: 1) G-CSF mobilized stem cell graft via apheresis for progenitor cell infusion and 2) Non-mobilized peripheral blood mononuclear cells (PBMC) via apheresis for subsequent CAR T-cell manufacturing and DLI if needed.
Patients that meet eligibility criteria to receive therapy will be consented to proceed on study. Treatment will include a conditioning chemotherapy preparative regimen followed by infusion of TCRαβ/CD19 B cell depleted progenitor cell infusion on day 0. Then as early as day + 14 patients will receive the previously manufactured CD19-CAR(Mem) T cell product. Patients will then be monitored for safety and efficacy of the infused CAR T-cell product, as well as collection of correlative samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAPALL Treatment | Experimental | Drug: Anti-Thymocyte Globulin (Rabbit), Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Thiotepa, Drug: Mesna, Drug: Melphalan, Drug: Filgrastim, Device: CliniMACS SystemPatients receive a conditioning regimen that will comprise of ATG, Fludarabine, Cyclophosphamide. Melphalan and Thiotepa. Following the conditioning regimen, patients receive infusion of TCRαβ+/CD19 B cell depleted progenitor cell infusion on day 0. Then as early as day + 14 patients will receive the previously manufactured CD19-CAR(Mem) T cell product. Patients will then be monitored for safety and efficacy of the infused CAR T-cell product, Cells for infusion are prepared using the CliniMACS system. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
- Recipient
- Age less than or equal to 21 years
- High risk hematologic malignancy where allogeneic transplantation is the current standard of care. This includes (but is not limited to):
- If prior CNS leukemia, it must be treated and in CNS CR
- Left ventricular ejection fraction > 40%, or shortening fraction ≥ 25%
Key exclusion criteria (11 listed)
- Recipient
- Has a suitable HLA-identical sibling or suitable 12/12 (HLA-A, B, C, DRB1, DQB1, and DPB1) HLA-matched unrelated donor available in an appropriate time frame
- Any other active malignancy other than the one for which this HCT is indicated
- Received a prior allogeneic HCT at any time
- Pregnant, if female is of childbearing potential, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment
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 |
|---|---|---|
| Anti-Thymocyte Globulin (Rabbit)Days -10, -11, -12. | Drug | HAPALL Treatment |
| Cyclophosphamide60 mg/kg intravenous once daily on day -9. | Drug | HAPALL Treatment |
| Fludarabine30 mg/m2 intravenous once daily for >10 kg, 1 mg/kg intravenous once daily for ≤10 kg on days -4, -5, -6, -7, -8. | Drug | HAPALL Treatment |
| Thiotepa5 mg/kg intravenous twice daily on day -3. | Drug | HAPALL Treatment |
| MesnaMesna is planned to be administered at 15 mg/kg/dose prior to cyclophosphamide and at approximately 3, 6, and 9 hours after the cyclophosphamide infusion, to give a 1:1 ratio of mesna:cyclophosphamide. | Drug | HAPALL Treatment |
| Melphalan70 mg/m2 intravenous once daily for >10 kg, 2.3 mg/kg intravenous once daily for ≤10 kg on days -1, and -2. | Drug | HAPALL Treatment |
| FilgrastimAlso: G-CSFG-CSF* 10 mcg/kg/day SC days 0, -1, -2, -3, -4, -5. | Drug | HAPALL Treatment |
| CliniMACS SystemThe mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest. | Device | HAPALL Treatment |
Primary outcome
To assess the safety of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.
Time frame: This will be assessed 100 days post-HCT
The primary analysis will compute the sample proportions and corresponding binomial exact 95% confidence intervals among evaluable patients for the following toxicities (separately for each toxicity) within 100 days post-HCT: 1) Severe aGVHD defined as Grade 3-4 aGVHD 2) Severe CRS defined as Grade 4 CRS that does not resolve to grade 3 or lower within 72 hours of onset 3) Severe ICANS defined as Grade 4 ICANS that does not resolve to grade 3 or lower within 72 hours of onset 4) TRM defined as death without prior relapse or disease progression within 100 days post-HCT 5) Other toxicity data will also be reported for a complete safety assessment of the study regimen.
To assess the feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.
Time frame: This will be assessed in the first 60 days post-HCT
this will be measured by the failure to receive CD19-CAR(Mem) T cells among patients who received HCT. The number of patients who fail to receive addback will be reported as the proportion who were unable to receive addback within 60 days post-HCT
6 secondary outcomes
To assess the feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.
Time frame: This will be assessed in the first 60 days post-HCT
Estimate 1-year post-transplant relapse free survival
Time frame: This will be assessed in the first 3 years post-HCT
Estimate cumulative incidence of neutrophil engraftment
Time frame: This will be assessed in the first 30 days post-HCT
Estimate cumulative incidence of platelet engraftment
Time frame: This will be assessed in the first 100 days post-HCT
Estimate cumulative incidence of acute and chronic GVHD
Time frame: This will be assessed in the first 3 years post-HCT
Estimate cumulative incidence of immune-related adverse events
Time frame: This will be assessed in the first 1 years post-HCT
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 28 Aug 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
Related trials for Relapsed Pediatric ALL
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 1
A Study of Codrituzumab in Children and Young Adults With Solid Tumors and Have Not Responded to Treatment or Have Come Back After Treatment
Primary Extra-cranial Solid Tumor, Recurrent or Refractory Glypican 3 (GPC3)
RecruitingPhase 3
Fight Osteosarcoma Through European Research Evolving Study Platform From Diagnosis to Relapse
Osteosarcoma, Pediatric Osteosarcoma
RecruitingPhase 1
Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia
RecruitingPhase 1/2
A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)
Malignant Neoplasm
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.
Swati Naik, MBBS principal investigator
St. Jude Children's Research 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 study testing Anti-Thymocyte Globulin (Rabbit), Cyclophosphamide and Fludarabine in people with Relapsed Pediatric ALL and Hematopoietic Cell Transplantation, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 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 28 Aug 2026. 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Swati Naik, MBBS (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies. (time frame: This will be assessed 100 days post-HCT). The study lists 2 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 28 Aug 2026.