Health TrialsbyHealthPanel

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

ConditionHigh Risk Non-muscle Invasive Bladder Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJecho Biopharmaceuticals Co., Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

1. Individuals who are allergic to any component of the investigational product.

Trial design

Design model

Single group

Treatments tested in this trial

  • JL19001 Injection

    Drug

    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.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: JL19001 Injection, 100 μg, intravesical instillationExperimental treatment 1 intervention
Group B: JL19001 Injection, 200 μg, intravesical instillationExperimental treatment 1 intervention
Group C: JL19001 Injection, 400 μg, intravesical instillationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number 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
2

Rate of adverse events

In accordance with NCI CTCAE v5.0, the toxicity assessment will be conducted.

Time frame
Up to 3 years
3

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

Secondary outcomes

1

Determination of JL19001 concentrations

Assays were performed using an ELLISA in the central laboratory.

Time frame
From the first administration to Week 6.
2

Detect anti-JL19001 antibodies in serum

Assays were performed using an ELLISA in the central laboratory.

Time frame
Up to 3 years
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jecho Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now