Advanced Solid TumorPhase 1NCT05621486

A Clinical Study to Evaluate B4T2-001 CAR T Cells in the Treatment of Advanced Solid Tumors

A Phase 1 study testing B4T2-001 Autologous CAR T cells in people with Advanced Solid Tumor, run by Shanghai East Hospital at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Advanced Solid Tumor
What is being tested?: B4T2-001 Autologous CAR T cells
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 2 sitesChina
Study dates: 14 Sep 2022to 31 Dec 2026
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subjects have been fully informed of the possible risks and benefits of participating in this study and have voluntarily signed the informed consent form (ICF);
Age:18-70 years (including 18 and 70 years);
ECOG 0-1;
With an expected survival of more than 3 months;
Histologically or cytologically confirmed locally advanced or metastatic BT-001 positive malignant solid tumors (including but not limited to gastric or gastroesophageal junction adenocarcinoma, pancreatic cancer, non-small cell lung cancer and breast cancer), who have failed standard treatment, or for whom standard treatment is not available or applicable at this stage;
Having measurable or evaluable lesions according to RECIST 1.1 or the latest version;

Show all 14Show fewer

Having sufficient bone marrow, liver and kidney functions (based on the normal value of the clinical trial site):
Absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 75×109/L;
Total serum bilirubin ≤ 1.5×upper limit of normal (ULN);
Without liver metastases, alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) ≤ 2.5×ULN; with liver metastases, ALT, AST, or ALP ≤ 5×ULN;
Serum creatinine (ScR) ≤ 1.5×ULN or creatinine clearance > 50 mL/min (calculated according to Cockcroft Gault formula);
International normalized ratio (INR) ≤ 1.5×ULN, APTT ≤ 1.5×ULN.
Adequate oxygen saturation (≥ 95%) can be maintained without oxygen inhalation;
Male or female patients of childbearing potential must agree to use effective methods of contraception (such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, and intrauterine devices) during the study period and within 1 year after infusion.

Who cannot join

Patients who have received the following anti-tumor treatments prior to apheresis:
Cytotoxic therapy within 14 days;
Small molecule targeted therapy within 14 days or at least 5 half-lives, whichever is longer;
Therapy with monoclonal antibody within 21 days;
Immunomodulatory therapy within 7 days;
Radiotherapy within 14 days;

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Traditional Chinese medicine with anti-tumor indications within 14 days;
Investigational agents or treatment within 28 days.
Previously treated with CAR-T/TCR-T cells therapy against any target or other cell therapies or therapeutic tumor vaccine;
Previously treated with any BT-001-targeted therapy;
Brain metastases with central nervous system symptoms;
Pregnant (positive pregnancy test prior to dosing) or breast-feeding women;
Allergic reaction to any drug and related excipients specified in protocol, e.g., lymphodepletion regimen (cyclophosphamide and fludarabine) and pre-infusion medication (acetaminophen and diphenhydramine), human serum albumin, tocilizumab, Erbitux/cetuximab, dimethyl sulfoxide (DMSO), and dextran 40;
Patients with active hepatitis B (hepatitis B surface antigen (HBsAg) is positive and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > 500IU/ml or lower limit of the research center [Only when the detection limit of the research center is higher than 500IU/ml]), or active hepatitis C (patients with positive HCV antibody but HCV-RNA < lower limit of detection at the site are allowed), but patients receiving prophylactic antiviral therapy other than interferon are allowed;
Patients with a history of immunodeficiency, including those who are HIV-positive, or patients with other acquired or congenital immune deficiency, or a history of organ transplantation;
Patients with autoimmune diseases;
Patients with active infection requiring intravenous anti-infective therapy based on the investigator's judgment;
Patients who underwent major surgeries within 2 weeks prior to apheresis and not fully recovered;
The toxicity of previous anti-cancer therapy has not returned to less than or equal to Grade 1 as specified in CTCAE v5.0 or the latest version (except for hair loss, Grade 2 peripheral neuropathy, and stable hypothyroidism treated with hormone replacement therapy);
Patients with severe complications such as active gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, renal failure, and uncontrolled diabetes;
Patients with a history of acute myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack within 6 months prior to the enrollment, or with NYHA Class 2 or higher congestive heart failure;
Patients with chronic diseases requiring treatment with systemic corticosteroids or other immunosuppressants, received systemic corticosteroids (≥ 70 mg prednisone or equivalent dose of other corticosteroids) or other immunosuppressants within 7 days before apheresis, except for the following cases: local, ocular, intra-articular, intranasal, and inhaled glucocorticoid treatment; short term use of glucocorticoids for preventive treatment (such as prevention of contrast medium allergy);
Patients with the third space effusion that cannot be controlled clinically are not suitable for inclusion in the group according to the judgment of the investigator;
Patients with a history of uncontrollable mental illness;
Patients with gastric cancer have gastric perforation, pyloric obstruction, or complete biliary obstruction;
Patients with pancreatic cancer who have tumor causing biliary obstruction;
Any condition in which the investigator considers that the subject is not suitable to participate in the study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Shanghai East Hospital
Shanghai, China/Shanghai, 200126
Shanghai Artemed Hospital
Shanghai, China/Shanghai, 200131

Other trials in China

About this study

Official title: A FIH, Single Arm, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Autologous CAR T Cells Targeting BT-001 in Patients With Advanced Solid Tumors

This is a first in human (FIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of B4T2-001 Autologous CAR T cells in subjects with advanced solid tumors including but not limited to advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, advanced pancreatic cancer, advanced non-small cell lung cancer (NSCLC), colorectal cancers (CRC) and metastatic breast cancer that tests positive for BT-001 target antigen according to Immunohistochemistry (IHC).

Read the detailed description

This is an open-label dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of B4T2-001 Autologous CAR T cells in subjects with BT-001 expressing advanced solid tumors. Patients who meet the eligibility criteria will receive B4T2-001 CAR T infusion after lymphodepletion. The lymphodepleting chemotherapy is administered on days -5, -4, and -3 before CAR T infusion using cyclophosphamide 300mg/m2 once daily and fludarabine 30mg/m2 once daily for 3 consecutive days. Doses may be adjusted for renal and/or hepatic insufficiency, or other comorbidities. The study is designed to include the following sequential steps: patient screening, pre-treatment, treatment and follow up for up to 2 years.

Conditions: Advanced Solid Tumor
Being tested: B4T2-001 Autologous CAR T cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

B4T2-001 Autologous CAR T cellsBiological
Each subject will receive infusion with B4T2-001 autologous CAR T Cells

Study groups in NCT05621486
Study group	Role	What they receive
B4T2-001 CAR T cells	Experimental	Single Arm and Open Label study consisting of dose escalation study design followed by dose expansion phase at determined MTD. Treatment follows a lymphodepleting chemotherapy regimen Receives: Biological: B4T2-001 Autologous CAR T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of serious adverse events (SAEs), incidence and severity of adverse events (AEs)
Safety and tolerability of B4T2-001 CAR T cells
Measured: Minimum 2 years after B4T2-001 CAR T infusion
To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of B4T2-001 CAR T cells
The MTD will be determined based on the occurrence of the Dose-Limiting Toxicities (DLTs) according to the accelerated titration design and 3+3 dose escalation design. RP2D will be defined based on MTD, safety, PK, and preliminary efficacy data.
Measured: 2 years after B4T2-001 CAR T infusion

Secondary outcomes (7)

Pharmacokinetics (PK): Area Under Curve (AUC)
Pharmacokinetics (PK): Area Under Curve (AUC) with immunoanalytical method
Measured: Blood sampling for PK will be performed at planned time points till the end of the study
Pharmacokinetics (PK): maximum concentration (Cmax)
Pharmacokinetics (PK): maximum concentration (Cmax) with immunoanalytical method
Measured: Blood sampling for PK will be performed at planned time points till the end of the study
Pharmacokinetics (PK): Time to Cmax (Tmax)
Pharmacokinetics (PK): Time to Cmax (Tmax) with immunoanalytical method
Measured: Blood sampling for PK will be performed at planned time points till the end of the study
Overall response rate (ORR) after administration
ORR is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment via B4T2-001 CAR T cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per RECIST 1.1 only
Measured: Minimum 2 years after B4T2-001 CAR T infusion
Duration of Response (DOR) after administration
DOR is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to RECIST 1.1) of the responders (who achieve PR or better response)
Measured: Minimum 2 years after B4T2-001 CAR T infusion
Progress Free Survival (PFS) after administration
PFS is defined as the time from the date of first infusion of the B4T2-001 to the first documented disease progression (according to RECIST 1.1) or death (due to any cause), whichever occurs first
Measured: Minimum 2 years after B4T2-001 CAR T infusion
Overall Survival (OS) after administration
OS is defined as the time from the date of first infusion of B4T2-001 CAR T to death of the subject
Measured: Minimum 2 years after B4T2-001 CAR T infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 202231 Dec 2026

First posted18 Nov 2022
Study start14 Sep 2022
Primary completion31 Dec 2024 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Advanced Solid TumorStudies 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05621486
Sponsor's protocol ID: B4T2-PRC-IIT-001
Status last verified: Nov 2022
First submitted: 3 Nov 2022
Last updated: 12 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338
Thompson JA, Schneider BJ, Brahmer J, Achufusi A, Armand P, Berkenstock MK, Bhatia S, Budde LE, Chokshi S, Davies M, Elshoury A, Gesthalter Y, Hegde A, Jain M, Kaffenberger BH, Lechner MG, Li T, Marr A, McGettigan S, McPherson J, Medina T, Mohindra NA, Olszanski AJ, Oluwole O, Patel SP, Patil P, Reddy S, Ryder M, Santomasso B, Shofer S, Sosman JA, Wang Y, Zaha VG, Lyons M, Dwyer M, Hang L. Management of Immunotherapy-Related Toxicities, Version 1.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Apr;20(4):387-405. doi: 10.6004/jnccn.2022.0020.
PubMed 35390769
Jo Y, Ali LA, Shim JA, Lee BH, Hong C. Innovative CAR-T Cell Therapy for Solid Tumor; Current Duel between CAR-T Spear and Tumor Shield. Cancers (Basel). 2020 Jul 28;12(8):2087. doi: 10.3390/cancers12082087.
PubMed 32731404
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774
Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25.
PubMed 30592986

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A FIH, Single Arm, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Autologous CAR T Cells Targeting BT-001 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05621486
Acronym / sponsor ID: B4T2-PRC-IIT-001
Conditions: Advanced Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 36 participants (estimated)
Lead sponsor: Shanghai East HospitalUniversity, hospital or other
Collaborators: Bio4T2 LLC
Study start: 14 Sep 2022 (actual)
Primary completion: 31 Dec 2024 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 18 Nov 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
B4T2-001 CAR T cells	Experimental	Biological: B4T2-001 Autologous CAR T cellsSingle Arm and Open Label study consisting of dose escalation study design followed by dose expansion phase at determined MTD. Treatment follows a lymphodepleting chemotherapy regimen

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

The subjects have been fully informed of the possible risks and benefits of participating in this study and have voluntarily signed the informed consent form (ICF);
Age:18-70 years (including 18 and 70 years);
ECOG 0-1;
With an expected survival of more than 3 months;
Histologically or cytologically confirmed locally advanced or metastatic BT-001 positive malignant solid tumors (including but not limited to gastric or gastroesophageal junction adenocarcinoma, pancreatic cancer, non-small cell lung cancer and breast cancer), who have failed standard treatment, or for whom standard treatment is not available or applicable at this stage;

Key exclusion criteria (27 listed)

Patients who have received the following anti-tumor treatments prior to apheresis:
Previously treated with CAR-T/TCR-T cells therapy against any target or other cell therapies or therapeutic tumor vaccine;
Previously treated with any BT-001-targeted therapy;
Brain metastases with central nervous system symptoms;
Pregnant (positive pregnancy test prior to dosing) or breast-feeding women;

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
B4T2-001 Autologous CAR T cellsEach subject will receive infusion with B4T2-001 autologous CAR T Cells	Biological	B4T2-001 CAR T cells

Primary outcome

Incidence of serious adverse events (SAEs), incidence and severity of adverse events (AEs)
Time frame: Minimum 2 years after B4T2-001 CAR T infusion
Safety and tolerability of B4T2-001 CAR T cells
To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of B4T2-001 CAR T cells
Time frame: 2 years after B4T2-001 CAR T infusion
The MTD will be determined based on the occurrence of the Dose-Limiting Toxicities (DLTs) according to the accelerated titration design and 3+3 dose escalation design. RP2D will be defined based on MTD, safety, PK, and preliminary efficacy data.

7 secondary outcomes

Pharmacokinetics (PK): Area Under Curve (AUC)
Time frame: Blood sampling for PK will be performed at planned time points till the end of the study
Pharmacokinetics (PK): maximum concentration (Cmax)
Time frame: Blood sampling for PK will be performed at planned time points till the end of the study
Pharmacokinetics (PK): Time to Cmax (Tmax)
Time frame: Blood sampling for PK will be performed at planned time points till the end of the study
Overall response rate (ORR) after administration
Time frame: Minimum 2 years after B4T2-001 CAR T infusion
Duration of Response (DOR) after administration
Time frame: Minimum 2 years after B4T2-001 CAR T infusion
Progress Free Survival (PFS) after administration
Time frame: Minimum 2 years after B4T2-001 CAR T infusion
Overall Survival (OS) after administration
Time frame: Minimum 2 years after B4T2-001 CAR T infusion

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 12 Oct 2023.
Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Background: PubMed 35390769Thompson JA, Schneider BJ, Brahmer J, Achufusi A, Armand P, Berkenstock MK, Bhatia S, Budde LE, Chokshi S, Davies M, Elshoury A, Gesthalter Y, Hegde A, Jain M, Kaffenberger BH, Lechner MG, Li T, Marr A, McGettigan S, McPherson J, Medina T, Mohindra NA, Olszanski AJ, Oluwole O, Patel SP, Patil P, Reddy S, Ryder M, Santomasso B, Shofer S, Sosman JA, Wang Y, Zaha VG, Lyons M, Dwyer M, Hang L. Management of Immunotherapy-Related Toxicities, Version 1.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Apr;20(4):387-405. doi: 10.6004/jnccn.2022.0020.
Background: PubMed 32731404Jo Y, Ali LA, Shim JA, Lee BH, Hong C. Innovative CAR-T Cell Therapy for Solid Tumor; Current Duel between CAR-T Spear and Tumor Shield. Cancers (Basel). 2020 Jul 28;12(8):2087. doi: 10.3390/cancers12082087.
Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
Background: PubMed 30592986Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25.
Individual participant dataSharing planned: No

Related trials for Advanced Solid Tumor

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Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jin Li, MD, PhD principal investigator

Shanghai East Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing B4T2-001 Autologous CAR T cells in people with Advanced Solid Tumor, run by Shanghai East Hospital at 2 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 14 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of serious adverse events (SAEs), incidence and severity of adverse events (AEs) (time frame: Minimum 2 years after B4T2-001 CAR T infusion). 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?

On the ClinicalTrials.gov record for NCT05621486, which also lists 5 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 12 Oct 2023.