High Risk Non-muscle Invasive Bladder CancerPhase 1JL19001-NMIBCNCT07483970

A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer.

A Phase 1 study testing JL19001 Injection in people with High Risk Non-muscle Invasive Bladder Cancer, run by Jecho Biopharmaceuticals Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Phase Ia, an open-label, sequential, dose escalation study to evaluate the tolerability and safety of JL19001 Injection alone in subjects with high risk NMIBC. The investigators plan to test 3 dose levels, 100, 200, and 400 μg in the Phase Ia study. A traditional 3 + 3 dose escalation design will be used. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: High Risk Non-muscle Invasive Bladder Cancer
What is being tested?: JL19001 Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteChina
Study dates: 18 May 2026to 30 Mar 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects should voluntarily sign the informed consent, and agree to comply with all protocol-specified procedures .
Male or female patients ≥18 years of age at the time of signing the ICF.
Life expectancy ≥ 2 years.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Previous pathological biopsy was diagnosed as high-risk NMIBC.
Cystoscopy showed complete resection of the lesion or the residual lesion is only CIS within 6 weeks prior to initial administration; For T1 lesions, postoperative pathological results must show the presence of bladder muscle layer.
After fully understanding the benefits, risks, and alternatives of radical cystectomy, the subject voluntarily chooses not to undergo the surgery; or the subject is deemed unsuitable for radical cystectomy by the researcher
Subjects with fertility and their partner should use contraception during the study treatment period and within 12 weeks after the end of the study treatment period. Non-surgical sterilized female subjects of reproductive age must be negative for serum HCG within 7 days prior to initial administration and must be non-lactating.

Who cannot join

1. Individuals who are allergic to any component of the investigational product.
2. Received surgical treatment or radiotherapy for bladder lesions within 2 weeks prior to initial administration
3. Any of the following clinical laboratory values During the screening period Hematology:absolute neutrophil count (ANC) < 1.5 ×109/L, platelets < 100 × 109/L, Hemoglobin<90 g/L(Within 14 days prior to screening, no whole blood transfusion, component blood transfusion, or drugs such as colony stimulating factors [For example: Granulocyte Colony-Stimulating Factor,Granulocyte-Macrophage Colony-Stimulating Factor,Erythropoietin,Thrombopoietin] have been administered.) renal function:Creatinine> 1.5×upper limit of normal(ULN)or Creatinine Clearance≥ 60mL/min(Calculate according to the Cockcroft-Gault formula); liver function(No history of liver protection treatment within 7 days prior to screening examination):Aspartate Aminotransferase > 2.5 × ULN;Alanine Aminotransferase > 2.5 × ULN;Total Bilirubin > 1.5× ULN; ECG examination: QT interval corrected by Fridericia (QTcF) > 450ms for males, QTcF > 470ms for females; Coagulation function: Activated Partial Thromboplastin Time > 1.5 × ULN; International Normalized Ratio > 1.5 × ULN; Prothrombin Time > 1.5 × ULN;
4. History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer (inclusive of the prostatic urethra).
5. There are contraindications to cystoscopy and/or urethroscopy, such as urethral stricture, urinary tract infection (UTI) (referring to symptomatic infection with positive urine culture), gross hematuria, and small bladder capacity, etc;
6. Bladder dysfunction during the screening period, such as severe urinary incontinence or overactive bladder (OAB); bladder perforation detected during the screening period through cystoscopy or imaging examination;

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7. During the screening period, if upper urinary tract tumors are detected during an upper urinary tract examination, or tumors in the prostatic urethra are detected during cystoscopy, or other malignant tumors are found within 5 years of the first dose, with the exception of skin basal cell carcinoma, squamous cell carcinoma, and cervical carcinoma in situ that have achieved complete remission or been effectively controlled through treatment, as well as Stage I/II cancers that have received adequate treatment, or stable prostate cancer that is under active monitoring in complete remission or well-managed through androgen therapy
8. Symptomatic congestive heart failure, New York Heart Association (NYHA) class III or IV heart failure, or other severe cardiac dysfunction, which the investigator deems clinically significant.
9. Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.
10. History or evidence of uncontrollable central nervous system disease.
11. Past medical history or examination suggests active tuberculosis within 1 year prior to initial administration;
12. Severely infected people who need to be controlled by antibiotics, antivirals or antifungals;
13. Have a history of immunodeficiency, including HIV seropositivity, other acquired or congenital immunodeficiency diseases.
14. The subject had received systemic glucocorticoid treatment within 2 weeks prior to the first administration of the test drug, except for the following situations: the hormone dose was ≤ 10mg/day in prednisone equivalent; local, inhaled, or intranasal use of glucocorticoids; and subjects with contrast medium allergy received prophylactic one-time use of glucocorticoids before undergoing imaging enhancement examination;
15. History of active autoimmune disease;
16. Active hepatitis B (HBe-Ag positive and HBV DNA>=500 IU/mL), hepatitis C (HCV antibody positive and HCV RNA higher than the lower limit of assay detection)
17. Received any other anti-tumor treatments within 4 weeks prior to the first dose, including systemic chemotherapy, small molecule targeted therapy, radiotherapy, and Chinese herbal medicine with anti-tumor effects, except for immediate bladder instillation chemotherapy performed after TURBT ≥ 14 days before dosing; Received immune checkpoint inhibitor therapy and antibody therapy within 6 months prior to the first dose;
18. The study is undergoing treatment in other clinical trials or has ended until less than 4 weeks after the first administration of the study;
19. The presence of other serious physical or mental illness, abnormal laboratory tests, and other factors that may increase the risk of participating in the study or interfere with the study results; And any other conditions that the investigator deems inappropriate for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Monitor contact

+86 187 2212 1165

yumei.zhang@jechobio.com

China1 site, 1 recruiting

West China Hospital of Sichuan University
Chengdu, Sichuan
wei qiang Principal Investigator, +86 28 8542 1550, wq933@hotmail.com
Recruiting

Other trials in China

About this study

Conditions: High Risk Non-muscle Invasive Bladder Cancer
Being tested: JL19001 Injection

What participants receive

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

JL19001 InjectionDrug
JL19001 Injection (100, 200, or 400 μg) will be administrated weekly for 6 consecutive weeks during induction treatment period, and then weekly for 3 consecutive weeks at month 3, 6, 9, 12, 18, 24, 30 and 36 during extension treatment period until disease progression, occurrence of unacceptable toxicity, withdrawal of informed consent, lost to follow-up, death, other reasons for withdrawal from treatment, or the end of treatment, whichever occurs earlier.

Study groups in NCT07483970
Study group	Role	What they receive
JL19001 Injection, 100 μg, intravesical instillation	Experimental	JL19001 Injection (100 μg) will be administrated weekly for 6 consecutive weeks during induction treatment period, and then weekly for 3 consecutive weeks at month 3, 6, 9, 12, 18, 24, 30 and 36 during extension treatment period until disease progression, occurrence of unacceptable toxicity, withdrawal of informed consent, lost to follow-up, death, other reasons for withdrawal from treatment, or the end of treatment, whichever occurs earlier. Receives: Drug: JL19001 Injection
JL19001 Injection, 200 μg, intravesical instillation	Experimental	JL19001 Injection (200 μg) will be administrated weekly for 6 consecutive weeks during induction treatment period via intravesical instillation, and then weekly for 3 consecutive weeks at month 3, 6, 9, 12, 18, 24, 30 and 36 during extension treatment period until disease progression, occurrence of unacceptable toxicity, withdrawal of informed consent, lost to follow-up, death, other reasons for withdrawal from treatment, or the end of treatment, whichever occurs earlier. Receives: Drug: JL19001 Injection
JL19001 Injection, 400 μg, intravesical instillation	Experimental	JL19001 Injection (400 μg) will be administrated weekly for 6 consecutive weeks during induction treatment period via intravesical instillation, and then weekly for 3 consecutive weeks at month 3, 6, 9, 12, 18, 24, 30 and 36 during extension treatment period until disease progression, occurrence of unacceptable toxicity, withdrawal of informed consent, lost to follow-up, death, other reasons for withdrawal from treatment, or the end of treatment, whichever occurs earlier. Receives: Drug: JL19001 Injection

What is being measured

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

Number of participants with reported Dose-limiting toxicity (DLT)
Evaluate according to the DLT standards specified in the protocol.
Measured: Within 21 days after the first administration
Rate of adverse events
In accordance with NCI CTCAE v5.0, the toxicity assessment will be conducted.
Measured: Up to 3 years
Determine the recommend dose for combination for JL19001 injection
Evaluate the data from the Phase Ia study to determine recommend dose for combination for JL19001 injection in Phase Ib.
Measured: Up to Month 36

Secondary outcomes (11)

Determination of JL19001 concentrations
Assays were performed using an ELLISA in the central laboratory.
Measured: From the first administration to Week 6.
Detect anti-JL19001 antibodies in serum
Assays were performed using an ELLISA in the central laboratory.
Measured: Up to 3 years
Determination of lymphocyte cell counts (cells/μL) in blood.
Assays were performed in the central laboratory.
Measured: From the first administration to Week 6.
Determination of CD8 T cell counts (cells/μL) in blood
Assays were performed in the central laboratory.
Measured: Time Frame: From the first administration to Week 6.
Determination of NK cell counts (cells/μL) in blood
Assays were performed in the central laboratory.
Measured: From the first administration to Week 6.
Radical cystectomy rate
Using urine cytology, cystoscopy or pathological biopsy, imaging
Measured: Up to 3 years.
Disease-free rate
Using urine cytology, cystoscopy or pathological biopsy, imaging.
Measured: Up to 3 years.
Duration of complete response
Using urine cytology, cystoscopy, pathological biopsy, and/or imaging
Measured: Up to 3 years.
Duration of disease-free survival
Using urine cytology, cystoscopy, pathological biopsy, and/or imaging
Measured: Up to 3 years.
Time to cystectomy
Using urine cytology, cystoscopy, pathological biopsy, and/or imaging
Measured: Up to 3 years.
Time to progression
Using urine cytology, cystoscopy, pathological biopsy, and/or imaging.
Measured: Up to 3 years.

Timeline

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

18 May 202630 Mar 2028

First posted19 Mar 2026
Study start18 May 2026
Primary completion30 Mar 2027 (estimated)
Study completion30 Mar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for High Risk Non-muscle Invasive Bladder CancerStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07483970
Sponsor's protocol ID: JL19001-NMIBC-101
Other IDs: 2025LP02620
Acronym: JL19001-NMIBC
Status last verified: Aug 2026
First submitted: 9 Mar 2026
Last updated: 6 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer.
ClinicalTrials.gov ID: NCT07483970
Acronym / sponsor ID: JL19001-NMIBC / JL19001-NMIBC-101
Conditions: High Risk Non-muscle Invasive Bladder Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 18 participants (estimated)
Lead sponsor: Jecho Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 18 May 2026 (actual)
Primary completion: 30 Mar 2027 (estimated)
Study completion: 30 Mar 2028 (estimated)
First posted: 19 Mar 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
JL19001 Injection, 100 μg, intravesical instillation	Experimental	Drug: JL19001 InjectionJL19001 Injection (100 μg) will be administrated weekly for 6 consecutive weeks during induction treatment period, and then weekly for 3 consecutive weeks at month 3, 6, 9, 12, 18, 24, 30 and 36 during extension treatment period until disease progression, occurrence of unacceptable toxicity, withdrawal of informed consent, lost to follow-up, death, other reasons for withdrawal from treatment, or the end of treatment, whichever occurs earlier.
JL19001 Injection, 200 μg, intravesical instillation	Experimental	Drug: JL19001 InjectionJL19001 Injection (200 μg) will be administrated weekly for 6 consecutive weeks during induction treatment period via intravesical instillation, and then weekly for 3 consecutive weeks at month 3, 6, 9, 12, 18, 24, 30 and 36 during extension treatment period until disease progression, occurrence of unacceptable toxicity, withdrawal of informed consent, lost to follow-up, death, other reasons for withdrawal from treatment, or the end of treatment, whichever occurs earlier.
JL19001 Injection, 400 μg, intravesical instillation	Experimental	Drug: JL19001 InjectionJL19001 Injection (400 μg) will be administrated weekly for 6 consecutive weeks during induction treatment period via intravesical instillation, and then weekly for 3 consecutive weeks at month 3, 6, 9, 12, 18, 24, 30 and 36 during extension treatment period until disease progression, occurrence of unacceptable toxicity, withdrawal of informed consent, lost to follow-up, death, other reasons for withdrawal from treatment, or the end of treatment, whichever occurs earlier.

Who may qualify

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

Key inclusion criteria (8 listed)

Subjects should voluntarily sign the informed consent, and agree to comply with all protocol-specified procedures .
Male or female patients ≥18 years of age at the time of signing the ICF.
Life expectancy ≥ 2 years.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Previous pathological biopsy was diagnosed as high-risk NMIBC.

Key exclusion criteria (19 listed)

1. Individuals who are allergic to any component of the investigational product.
2. Received surgical treatment or radiotherapy for bladder lesions within 2 weeks prior to initial administration
3. Any of the following clinical laboratory values During the screening period Hematology:absolute neutrophil count (ANC) < 1.5 ×109/L, platelets < 100 × 109/L, Hemoglobin<90 g/L(Within 14 days prior to screening, no whole blood transfusion, component blood transfusion, or drugs such as colony stimulating factors [For example: Granulocyte Colony-Stimulating Factor,Granulocyte-Macrophage Colony-Stimulating Factor,Erythropoietin,Thrombopoietin] have been administered.) renal function:Creatinine> 1.5×upper limit of normal(ULN)or Creatinine Clearance≥ 60mL/min(Calculate according to the Cockcroft-Gault formula); liver function(No history of liver protection treatment within 7 days prior to screening examination):Aspartate Aminotransferase > 2.5 × ULN;Alanine Aminotransferase > 2.5 × ULN;Total Bilirubin > 1.5× ULN; ECG examination: QT interval corrected by Fridericia (QTcF) > 450ms for males, QTcF > 470ms for females; Coagulation function: Activated Partial Thromboplastin Time > 1.5 × ULN; International Normalized Ratio > 1.5 × ULN; Prothrombin Time > 1.5 × ULN;
4. History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer (inclusive of the prostatic urethra).
5. There are contraindications to cystoscopy and/or urethroscopy, such as urethral stricture, urinary tract infection (UTI) (referring to symptomatic infection with positive urine culture), gross hematuria, and small bladder capacity, etc;

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
JL19001 InjectionJL19001 Injection (100, 200, or 400 μg) will be administrated weekly for 6 consecutive weeks during induction treatment period, and then weekly for 3 consecutive weeks at month 3, 6, 9, 12, 18, 24, 30 and 36 during extension treatment period until disease progression, occurrence of unacceptable toxicity, withdrawal of informed consent, lost to follow-up, death, other reasons for withdrawal from treatment, or the end of treatment, whichever occurs earlier.	Drug	JL19001 Injection, 100 μg, intravesical instillation, JL19001 Injection, 200 μg, intravesical instillation, JL19001 Injection, 400 μg, intravesical instillation

Primary outcome

Number of participants with reported Dose-limiting toxicity (DLT)
Time frame: Within 21 days after the first administration
Evaluate according to the DLT standards specified in the protocol.
Rate of adverse events
Time frame: Up to 3 years
In accordance with NCI CTCAE v5.0, the toxicity assessment will be conducted.
Determine the recommend dose for combination for JL19001 injection
Time frame: Up to Month 36
Evaluate the data from the Phase Ia study to determine recommend dose for combination for JL19001 injection in Phase Ib.

11 secondary outcomes

Determination of JL19001 concentrations
Time frame: From the first administration to Week 6.
Detect anti-JL19001 antibodies in serum
Time frame: Up to 3 years
Determination of lymphocyte cell counts (cells/μL) in blood.
Time frame: From the first administration to Week 6.
Determination of CD8 T cell counts (cells/μL) in blood
Time frame: Time Frame: From the first administration to Week 6.
Determination of NK cell counts (cells/μL) in blood
Time frame: From the first administration to Week 6.
Radical cystectomy rate
Time frame: Up to 3 years.
Disease-free rate
Time frame: Up to 3 years.
Duration of complete response
Time frame: Up to 3 years.
Duration of disease-free survival
Time frame: Up to 3 years.
Time to cystectomy
Time frame: Up to 3 years.
Time to progression
Time frame: Up to 3 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 6 Aug 2026.
Individual participant dataSharing planned: Undecided

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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.

Clinical Monitor contact

+86 187 2212 1165

yumei.zhang@jechobio.com

Qiang Wei principal investigator

West China 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 JL19001 Injection in people with High Risk Non-muscle Invasive Bladder Cancer, run by Jecho Biopharmaceuticals Co., Ltd. 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 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 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 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 Clinical Monitor (+86 187 2212 1165, yumei.zhang@jechobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with reported Dose-limiting toxicity (DLT) (time frame: Within 21 days after the first administration). 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?

On the ClinicalTrials.gov record for NCT07483970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.