Bladder Cancer (BC)Phase 1NCT07359235
Safety, Tolerability, and Preliminary Efficacy of KD01 Via Intravesical Instillation in Bladder Cancer (BC)
A Phase 1 study testing KD01(the recombinant oncolytic adenovirus) in people with Bladder Cancer (BC), run by Tongji Hospital at 1 site in China.
Trial summary
Recombinant oncolytic adenovirus injection (KD01) is an oncolytic virus product. Its main component is a conditionally replicative recombinant human type 5 adenovirus, where part of the E3 region has been replaced with the gene encoding the tBid apoptotic protein.AK104 is a humanized bispecific antibody co-targeting… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bladder Cancer (BC)
- What is being tested?
- KD01(the recombinant oncolytic adenovirus)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2024to 31 Dec 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.The Phase Ia will include histopathologically confirmed non-muscle-invasive bladder cancer (NMIBC) patients with high-risk stratification (including extremely high-risk). High-risk stratification criteria are defined as G3/high-grade tumors that meet any of the following criteria: carcinoma in situ (CIS); stage T1; diameter>3 cm; multiple tumors; or recurrent tumors. The Phase Ib Cohort A will include BCG unresponsive NMIBC patients with carcinoma in situ [CIS], with or without Ta/T1 stage lesions, while Cohort B will include histopathologically confirmed muscle-invasive bladder cancer (cT2-4aN0-1M0).Note: BCG non-response is defined as meeting any of the following criteria: 1. Persistent or recurrent CIS within 12 months after completing adequate BCG treatment; 2. Recurrence of high-grade Ta/Tl disease within 6 months after completing adequate BCG treatment; 3. High-grade T1 disease at first evaluation after induction BCG treatment. (Adequate BCG treatment is defined as: Complete at least 5 out of 6 doses in the initial induction course. plus 2 out of 6 doses from the second induction course, or 2 doses from the 3-dose maintenance course.)
- 2.Excluding Phase Ib Cohort B, participants must either be medically ineligible for radical cystectomy as determined by urologists or have declined the procedure.
- 3.Age 18 to 75 (including 18 and 75).
- 4.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1.
- 5.Estimated survival time is ≥2 years.6.No dysfunction of major organs, including but not limited to hematopoietic function and cardiac, pulmonary,hepatic and renal function.
- Hematologic system (no history of blood transfusion or hematopoietic growth factor treatment within 14 days)
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- Absolute neutrophil count (ANC)≥1.5×109/L
- Platelets （PLT）≥75×109/L
- Hemoglobin （Hb）≥90g/L
- Hepatic function
- Total bilirubin (TBIL)≤1.5× upper limit (ULN)
- Alanine aminotransferase (ALT)≤3×ULN
- Aspartate aminotransferase (AST)≤3×ULN
- Renal function
- Creatinine （Cr）≤1.5×ULN
- Creatinine clearance (Ccr) (Calculation required only if creatinine exceeds 1.5×ULN)>50 mL/min (calculated using the Cockcroft-Gault formula)
- Coagulation function
- Activated Partial Thromboplastin Time (APTT)≤1.5×ULN
- International normalized ratio (INR)≤1.5×ULN
- 7.Premenopausal patients must have a negative blood pregnancy test during the screening period;they must agree to use reliable contraceptive methods (barrier contraceptive method or abstinence) with their partners during the trial and for at least 6 months after the last dose.
- 8.Patients must provide informed consent to the trial and voluntarily sign of a written informed consent form before participating in the trial.
Who cannot join
- 1.Evidence of metastatic disease, or multiple regional lymph node positivity in the true pelvis, or common iliac lymph node positivity at the screening visit. Accompanied by hydronephrosis.
- 2.Received pelvic external beam radiation therapy within 5 years.
- 3.Prior treatment with adenovirus-based therapies (e.g., oncolytic adenovirus, CanSino's Ad5-nCoV COVID-19 vaccine).
- 4.Symptomatic urinary tract infection or bacterial cystitis (patients can enter the study once the treatment is satisfactory).
- 5.Clinically significant and unexplained elevation of liver or kidney function markers.
- 6.Women who are pregnant or breastfeeding or refuse to use contraception at any time during the study; male patients who are unwilling to use effective contraception.
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- 7.A history of malignancy in another organ system in the past 5 years, which the investigator believes may interfere with the conduct of the study or requires systemic study treatment for the malignancy.
- 8.Patients who cannot tolerate intravesical instillation for 1 hour or bladder surgery.
- 9.In addition to immediate postoperative instillation after TURBT , patients who have received anti-tumor treatments (including chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc.) within 4 weeks before the first study drug administration must be excluded. Specifically, patients who have used nitrosourea drugs or mitomycin C within 6 weeks prior to the initial study drug administration must be excluded Patients who have used oral fluorouracil and small-molecule targeted drugs within 2 weeks prior to the first administration of the study drug or within 5 half-lives of the drugs (whichever is longer) must be excluded. Patients who have used TCMs with anti-tumor indications within 2 weeks prior to the first administration must be excluded.
- 10.History of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, or second-to third-degree atrioventricular block;
- At rest, the QTcF (calculated from 12-lead ECG) is ≥460ms.
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before the first administration;
- Patients with NYHA class ≥II or left ventricular ejection fraction (LVEF) <50%, or those with structural heart disease deemed high-risk by other researchers.
- Hypertension that is not clinically controlled.
- 11.Patients with autoimmune diseases, or immune system dysfunction, or after organ transplantation.
- 12.Patients with active infection, or those requiring systemic anti-infective therapy (routine prophylactic anti-infective therapy at the clinical trial site is excluded), or those with unexplained fever > 38.5℃ during screening.
- 13.Patients with positive HIV antibodies (HIV-Ab) or Treponema pallidum antibodies; those with active hepatitis B (HBsAg-positive with HBV-DNA>500 IU/ml or above the clinical trial institution's lower limit of detection [only if the lower limit of detection exceeds 500 IU/ml]); and those with active hepatitis C (HCV-positive but HCV-RNA below the clinical trial institution's lower limit of detection are eligible). Patients receiving prophylactic antiviral therapy other than interferon are also eligible.
- 14.Patients with uncontrolled seizures, central nervous system disorders or psychosis with loss of cognitive ability.
- 15.The severity of adverse reactions from prior anti-tumor treatments has not recovered to ≤Level 1 (according to the Common Terminology Criteria for Adverse Events (CTCAE) 5.0), except for toxicities such as hair loss that researchers have determined to be non-safety risks.
- 16.Antiviral therapy is currently required, or antiviral drugs were used within 2 weeks before the first use of the trial drug.
- 17.Participants who received any live virus vaccine for infectious disease prevention within 4 weeks prior to the study drug administration. Examples of live vaccines include, but are not limited to: measles, mumps, rubella, chickenpox/herpes zoster (varicella), yellow fever, rabies, BCG, and typhoid vaccines. Influenza vaccines for injection are generally inactivated virus vaccines and are permitted; however, intranasal influenza vaccines (e.g., FluMisT®) are live attenuated vaccines and are not permitted.
- 18.Patients who have received systemic glucocorticoids (prednisone>10mg or equivalent doses of similar drugs) or other immunosuppressants within 14 days prior to trial drug administration must be excluded. Exceptions include: topical, ocular, intra-articular, intranasal, or inhaled glucocorticoid treatments; and short-term prophylactic glucocorticoid use (e.g., for preventing contrast agent allergies).
- 19.Patients with severe allergy history or allergic constitution.
- 20.Patients with a history of allogeneic hematopoietic stem cell transplantation or organ transplantation must be excluded.
- 21.Other circumstances that the investigator deems inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430074
Zheng Liu PhD, +86 13297997093, lz2013tj@163.com
Zheng Liu, PhD
About this study
Official title: A Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Recombinant Oncolytic Adenovirus Injection (KD01) Via Intravesical Instillation in Bladder Cancer (BC)
Recombinant oncolytic adenovirus injection (KD01) is an oncolytic virus product. Its main component is a conditionally replicative recombinant human type 5 adenovirus, where part of the E3 region has been replaced with the gene encoding the tBid apoptotic protein.AK104 is a humanized bispecific antibody co-targeting PD-1 (Programmed Cell Death Protein 1) and CTLA-4 (Cytotoxic T-Lymphocyte-Associated Antigen 4)-two key immune checkpoint receptors. It is designed as a novel tetrameric construct that preferentially binds to tumor-infiltrating lymphocytes (TILs) co-expressing PD-1 and CTLA-4 in the tumor microenvironment (with higher avidity than in peripheral tissues).This is a Phase I clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of intravesical instillation of recombinant oncolytic adenovirus injection (KD01) in patients with bladder cancer.This study consists of Phase Ia and Phase Ib, where Phase Ia is a dose-escalation stage.The Phase Ia will include histopathologically confirmed non-muscle-invasive bladder cancer (NMIBC) patients with high-risk stratification (including extremely high-risk).The Phase Ib study will include two independent cohorts: Cohort A comprises high-risk non-muscle-invasive bladder cancer (NMIBC) patients (carcinoma in situ [CIS], with or without Ta/T1 stage lesions) who have shown no response to BCG. Cohort B will include T2-4aN0-1M0 stage bladder cancer patients (clinically localized muscle-invasive bladder urothelial carcinoma).
- Conditions
- Bladder Cancer (BC)
- Being tested
- KD01(the recombinant oncolytic adenovirus)
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KD01(the recombinant oncolytic adenovirus)Drug
Drug： Phase Ia：KD01(3 dose groups: 2.6×10¹¹ VP, 5×10¹¹ VP, and 1×10¹² VP) Phase Ib: KD01(5×10¹¹ VP) with AK104(6 mg/kg, given intravenously every two weeks) Administration： Phase Ia: KD01 will be administered weekly during weeks 1-6, 13-15, 25-27, 37-39, 49-51, 73, 97. If patients present with CIS and/or high-grade Ta at the first efficacy assessment in week 12, KD01 will be administered weekly during weeks 16-18. Phase Ib Cohort A: KD01 for the same treatment duration as Phase Ia. AK104: The initial 6 doses will be administered, and subsequent doses will be continued based on the investigator's assessment of the patient's condition and the patient's willingness. Phase Ib Cohort B: KD01 will be administered weekly during weeks 1-6,with AK104 (3 doses). A transurethral resection of the bladder tumor (TURBT) is recommended 2-4 weeks after the final KD01 dose for residual or suspicious tumors, with subsequent treatment determined by investigators based on imaging results.
| Study group | Role | What they receive |
|---|---|---|
| KD01 treatment: | Experimental | Monotherapy with KD01 or combination therapy with KD01 plus AK104 for the treatment of bladder cancer. Receives: Drug: KD01(the recombinant oncolytic adenovirus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAEs and AEs（Phase Ia）
The incidence of serious adverse events (SAEs), the incidence and severity of adverse events (AEs).
Measured: 2 years
MTD
Phase Ia: The maximum tolerated dose (MTD) is determined based on the incidence of dose-limiting toxicity (DLT).
Measured: 2 years
SAEs and AEs（Phase Ib）
The incidence of serious adverse events (SAEs), the incidence and severity of adverse events (AEs).
Measured: 2 years
Secondary outcomes (7)
CRR(Phase Ia and Phase Ib Cohort A)
Phase Ia and Phase Ib Cohort A: Complete Response (CR) rates at any time points and at 3, 6, 12,15,18, and 24 months.
Measured: 24 months
DOR（Phase Ia and Phase Ib Cohort A）
Phase Ia and Phase Ib Cohort A: Duration of Response (DOR) at these time points.
Measured: 24 months
CRR(Phase Ib Cohort B)
Phase Ib Cohort B: includes the incidence of pathological complete response (pT0N0) .
Measured: 24 months
PRR(Phase Ib Cohort B)
Phase Ib Cohort B: includes the incidence of pathological partial response（<pT2N0）.
Measured: 24 months
Incidence of cystectomy
Incidence of cystectomy during the study.
Measured: 24 months
RFS
The time interval from the completion of curative treatment to the first recurrence of the disease。
Measured: 12 months
Biodistribution
The detected concentrations of KD01 in blood, urine, feces, and saliva in Phase Ia patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start4 Nov 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Cancer (BC)Studies of the same condition, open and under way.
- More trials run by Tongji 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
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Liu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359235
- Sponsor's protocol ID
- 2025-TJ-KD01T02
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 22 Jan 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Recombinant Oncolytic Adenovirus Injection (KD01) Via Intravesical Instillation in Bladder Cancer (BC)
- ClinicalTrials.gov ID
- NCT07359235
- Acronym / sponsor ID
- 2025-TJ-KD01T02
- Conditions
- Bladder Cancer (BC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jan 2026 (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.
Recombinant oncolytic adenovirus injection (KD01) is an oncolytic virus product. Its main component is a conditionally replicative recombinant human type 5 adenovirus, where part of the E3 region has been replaced with the gene encoding the tBid apoptotic protein.AK104 is a humanized bispecific antibody co-targeting PD-1 (Programmed Cell Death Protein 1) and CTLA-4 (Cytotoxic T-Lymphocyte-Associated Antigen 4)-two key immune checkpoint receptors. It is designed as a novel tetrameric construct that preferentially binds to tumor-infiltrating lymphocytes (TILs) co-expressing PD-1 and CTLA-4 in the tumor microenvironment (with higher avidity than in peripheral tissues).This is a Phase I clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of intravesical instillation of recombinant oncolytic adenovirus injection (KD01) in patients with bladder cancer.This study consists of Phase Ia and Phase Ib, where Phase Ia is a dose-escalation stage.The Phase Ia will include histopathologically confirmed non-muscle-invasive bladder cancer (NMIBC) patients with high-risk stratification (including extremely high-risk).The Phase Ib study will include two independent cohorts: Cohort A comprises high-risk non-muscle-invasive bladder cancer (NMIBC) patients (carcinoma in situ [CIS], with or without Ta/T1 stage lesions) who have shown no response to BCG. Cohort B will include T2-4aN0-1M0 stage bladder cancer patients (clinically localized muscle-invasive bladder urothelial carcinoma).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KD01 treatment: | Experimental | Drug: KD01(the recombinant oncolytic adenovirus)Monotherapy with KD01 or combination therapy with KD01 plus AK104 for the treatment of bladder cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 1.The Phase Ia will include histopathologically confirmed non-muscle-invasive bladder cancer (NMIBC) patients with high-risk stratification (including extremely high-risk). High-risk stratification criteria are defined as G3/high-grade tumors that meet any of the following criteria: carcinoma in situ (CIS); stage T1; diameter>3 cm; multiple tumors; or recurrent tumors. The Phase Ib Cohort A will include BCG unresponsive NMIBC patients with carcinoma in situ [CIS], with or without Ta/T1 stage lesions, while Cohort B will include histopathologically confirmed muscle-invasive bladder cancer (cT2-4aN0-1M0).Note: BCG non-response is defined as meeting any of the following criteria: 1. Persistent or recurrent CIS within 12 months after completing adequate BCG treatment; 2. Recurrence of high-grade Ta/Tl disease within 6 months after completing adequate BCG treatment; 3. High-grade T1 disease at first evaluation after induction BCG treatment. (Adequate BCG treatment is defined as: Complete at least 5 out of 6 doses in the initial induction course. plus 2 out of 6 doses from the second induction course, or 2 doses from the 3-dose maintenance course.)
- 2.Excluding Phase Ib Cohort B, participants must either be medically ineligible for radical cystectomy as determined by urologists or have declined the procedure.
- 3.Age 18 to 75 (including 18 and 75).
- 4.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1.
- 5.Estimated survival time is ≥2 years.6.No dysfunction of major organs, including but not limited to hematopoietic function and cardiac, pulmonary,hepatic and renal function.
Key exclusion criteria (26 listed)
- 1.Evidence of metastatic disease, or multiple regional lymph node positivity in the true pelvis, or common iliac lymph node positivity at the screening visit. Accompanied by hydronephrosis.
- 2.Received pelvic external beam radiation therapy within 5 years.
- 3.Prior treatment with adenovirus-based therapies (e.g., oncolytic adenovirus, CanSino's Ad5-nCoV COVID-19 vaccine).
- 4.Symptomatic urinary tract infection or bacterial cystitis (patients can enter the study once the treatment is satisfactory).
- 5.Clinically significant and unexplained elevation of liver or kidney function markers.
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 |
|---|---|---|
| KD01(the recombinant oncolytic adenovirus)Drug： Phase Ia：KD01(3 dose groups: 2.6×10¹¹ VP, 5×10¹¹ VP, and 1×10¹² VP) Phase Ib: KD01(5×10¹¹ VP) with AK104(6 mg/kg, given intravenously every two weeks) Administration： Phase Ia: KD01 will be administered weekly during weeks 1-6, 13-15, 25-27, 37-39, 49-51, 73, 97. If patients present with CIS and/or high-grade Ta at the first efficacy assessment in week 12, KD01 will be administered weekly during weeks 16-18. Phase Ib Cohort A: KD01 for the same treatment duration as Phase Ia. AK104: The initial 6 doses will be administered, and subsequent doses will be continued based on the investigator's assessment of the patient's condition and the patient's willingness. Phase Ib Cohort B: KD01 will be administered weekly during weeks 1-6,with AK104 (3 doses). A transurethral resection of the bladder tumor (TURBT) is recommended 2-4 weeks after the final KD01 dose for residual or suspicious tumors, with subsequent treatment determined by investigators based on imaging results. | Drug | KD01 treatment: |
Primary outcome
SAEs and AEs（Phase Ia）
Time frame: 2 years
The incidence of serious adverse events (SAEs), the incidence and severity of adverse events (AEs).
MTD
Time frame: 2 years
Phase Ia: The maximum tolerated dose (MTD) is determined based on the incidence of dose-limiting toxicity (DLT).
SAEs and AEs（Phase Ib）
Time frame: 2 years
The incidence of serious adverse events (SAEs), the incidence and severity of adverse events (AEs).
7 secondary outcomes
CRR(Phase Ia and Phase Ib Cohort A)
Time frame: 24 months
DOR（Phase Ia and Phase Ib Cohort A）
Time frame: 24 months
CRR(Phase Ib Cohort B)
Time frame: 24 months
PRR(Phase Ib Cohort B)
Time frame: 24 months
Incidence of cystectomy
Time frame: 24 months
RFS
Time frame: 12 months
Biodistribution
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 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.
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 KD01(the recombinant oncolytic adenovirus) in people with Bladder Cancer (BC), run by Tongji Hospital at 1 site 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 21 inclusion and 26 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 22 Jan 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 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?
Contact Zheng Liu, Dr. (+86 13297997093, lz2013tj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAEs and AEs（Phase Ia） (time frame: 2 years). 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 22 Jan 2026.