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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGNumber of participants with reported Dose-limiting toxicity (DLT)
Evaluate according to the DLT standards specified in the protocol.
Time frame: Within 21 days after the first administration
Rate of adverse events
In accordance with NCI CTCAE v5.0, the toxicity assessment will be conducted.
Time frame: 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.
Time frame: Up to Month 36
Determination of JL19001 concentrations
Assays were performed using an ELLISA in the central laboratory.
Time frame: From the first administration to Week 6.
Detect anti-JL19001 antibodies in serum
Assays were performed using an ELLISA in the central laboratory.
Time frame: Up to 3 years
Determination of lymphocyte cell counts (cells/μL) in blood.
Assays were performed in the central laboratory.
Time frame: 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: 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.
Time frame: From the first administration to Week 6.
Radical cystectomy rate
Using urine cytology, cystoscopy or pathological biopsy, imaging
Time frame: Up to 3 years.
Disease-free rate
Using urine cytology, cystoscopy or pathological biopsy, imaging.
Time frame: Up to 3 years.
Duration of complete response
Using urine cytology, cystoscopy, pathological biopsy, and/or imaging
Time frame: Up to 3 years.
Duration of disease-free survival
Using urine cytology, cystoscopy, pathological biopsy, and/or imaging
Time frame: Up to 3 years.
Time to cystectomy
Using urine cytology, cystoscopy, pathological biopsy, and/or imaging
Time frame: Up to 3 years.
Time to progression
Using urine cytology, cystoscopy, pathological biopsy, and/or imaging.
Time frame: Up to 3 years.
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