This is a Phase I, multicenter, single-arm, open-label clinical study designed to evaluate the safety and tolerability of JL19001 Injection as monotherapy (Phase Ia) or in combination with standard therapy (Phase Ib) in patients with AST and r/r B-NHL. Only the Phase Ia protocol design is registered at this time. A total of 6 dose cohorts are planned for Phase Ia, i.e., 1, 5, 10, 15, 20, and 25 μg/kg, with the administration route being subcutaneous injection. A traditional 3 + 3 dose escalation design will be used. The MTD and Recommended Maximum Add-on Dose (RMAD) for JL19001 Injection will be determined.
Age and Gender: Aged ≥ 18 years at the time of signing the Informed Consent Form (ICF), regardless of gender.
Measurable Disease: Presence of at least one evaluable tumor lesion according to RECIST 1.1 (solid tumors) or Lugano criteria (lymphoma). Note: Lesions previously irradiated are not considered target lesions unless there is documented progression within the irradiated field or persistence of the lesion >3 months after radiotherapy.
Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (refer to Appendix 1: ECOG Performance Status).
Life Expectancy: Expected survival ≥ 12 weeks.
Hypersensitivity: Known hypersensitivity to any component of the investigational product or to drugs of the same class.
QTc interval > 450 ms (male) or > 470 ms (female).
New York Heart Association (NYHA) Class III or IV congestive heart failure.
Unstable angina, new-onset angina, or myocardial infarction within 6 months prior to screening.
Sequential
JL19001, subcutaneous injection, 1 μg/kg
DrugJL19001, subcutaneous injection, 1 μg/kg
JL19001, subcutaneous injection, 5 μg/kg
DrugJL19001, subcutaneous injection, 5 μg/kg
JL19001, subcutaneous injection,10 μg/kg
DrugJL19001, subcutaneous injection,10 μg/kg
JL19001, subcutaneous injection,15 μg/kg
DrugJL19001, subcutaneous injection,15 μg/kg
JL19001, subcutaneous injection,20 μg/kg
DrugJL19001, subcutaneous injection,20 μg/kg
JL19001, subcutaneous injection,25 μg/kg
DrugJL19001, subcutaneous injection,25 μg/kg
6
Treatment groupsSee each treatment group below.
Number of participants with reported Dose-limiting toxicity (DLT)
The Maximum tolerated dose (MTD)
Recommended Maximum Add-on Dose (RMAD)
Recommended Phase 2 Dose (RP2D)
Determination of JL19001 concentrations
Assays were performed using an ELLISA in the central laboratory.
Determination of lymphocyte cell counts in blood.
Determination of CD4+T cell counts in blood.
Determination of CD8+T cell counts in blood.
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