JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid T… (NCT07603479) | Clinical Trial Compass
RecruitingPhase 1
JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
China14 participantsStarted 2026-06-25
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age and Gender: Aged ≥ 18 years at the time of signing the Informed Consent Form (ICF), regardless of gender.
. Disease Status: Patients with histologically or cytologically confirmed advanced solid tumors (AST) or relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) who have failed standard therapy, have no available standard treatment options, are intolerant to, or refuse standard therapy. This includes, but is not limited to, melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (SCCHN), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone B-cell lymphoma (MZL). Specific requirements for each tumor type are as follows:
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with reported Dose-limiting toxicity (DLT)
Timeframe: Within 28 days after the first administration
. Laboratory Parameters: Adequate organ function within 14 days prior to enrollment, defined as:
. Life Expectancy: Expected survival ≥ 12 weeks.
. Contraception and Pregnancy:
. Consent and Compliance: Ability to understand and voluntarily sign the ICF, and willingness to comply with scheduled visits as per protocol.
Exclusion criteria
. Hypersensitivity: Known hypersensitivity to any component of the investigational product or to drugs of the same class.
. CNS Metastases:
. Cardiac Conditions: Any of the following cardiac conditions:
. 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.
. Clinically significant arrhythmias, including but not limited to complete left bundle branch block, second-degree atrioventricular block, or PR interval \> 250 ms.