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

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. Eligible subjects will be sequentially enrolled and will be observed for DLT(s) during the DLT monitoring period (Day 1 ~ 21).

Study Overview

• Status: Not yet recruiting
• Conditions: High Risk Non-muscle Invasive Bladder Cancer
• Intervention / Treatment: Drug: JL19001 Injection

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Monitor; Phone Number: +86 187 2212 1165; Email: yumei.zhang@jechobio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects should voluntarily sign the informed consent, and agree to comply with all protocol-specified procedures .
2. Male or female patients ≥18 years of age at the time of signing the ICF.
3. Life expectancy ≥ 2 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
5. Previous pathological biopsy was diagnosed as high-risk NMIBC.
6. 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.
7. 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
8. 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.

Exclusion Criteria:

• 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;

  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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JL19001 Injection, 100 μg, intravesical instillation; 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.	Drug: JL19001 Injection; 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.
Experimental: JL19001 Injection, 200 μg, intravesical instillation; 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.	Drug: JL19001 Injection; 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.
Experimental: JL19001 Injection, 400 μg, intravesical instillation; 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.	Drug: JL19001 Injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with reported Dose-limiting toxicity (DLT)	Evaluate according to the DLT standards specified in the protocol.	Within 21 days after the first administration
Rate of adverse events	In accordance with NCI CTCAE v5.0, the toxicity assessment will be conducted.	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.	Up to Month 36

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jecho Biopharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Qiang Wei, West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: JL19001-NMIBC-101; 2025LP02620 (Registry Identifier: China National Medical Products Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No