MalignanciesPhase 1NCT07603479
JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
A Phase 1 study testing JL19001, subcutaneous injection, 1 μg/kg, JL19001, subcutaneous injection, 5 μg/kg and JL19001, subcutaneous injection,10 μg/kg in people with Malignancies and Solid Malignant Tumor, run by Jecho Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancies, Solid Malignant Tumor, NHL (Non-Hodgkin Lymphoma)
- What is being tested?
- JL19001, subcutaneous injection, 1 μg/kg, JL19001, subcutaneous injection, 5 μg/kg and JL19001, subcutaneous injection,10 μg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2026to May 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for this study:
- 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:
- Melanoma: Advanced cutaneous or acral melanoma with progressive disease (PD) after ≥2 prior lines of systemic therapy. Prior treatment must include at least one immune checkpoint inhibitor (ICI; e.g., pembrolizumab, toripalimab, pucotenlimab, ipilimumab + nivolumab, atezolizumab) and at least one chemotherapy (e.g., dacarbazine, temozolomide, paclitaxel, nab-paclitaxel, cisplatin/carboplatin, fotemustine). For patients with BRAF V600, NRAS, or KITmutations, prior treatment must include at least one targeted therapy against the specific mutation and one ICI (as listed above). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.
- RCC: Metastatic or unresectable clear cell RCC with PD after ≥1 prior line of therapy or intolerance to ≥1 prior line. Prior treatment must include at least one targeted therapy (e.g., sunitinib, pazopanib, sorafenib, axitinib, lenvatinib, anlotinib, vorolanib + everolimus) and one ICI (e.g., toripalimab, pembrolizumab, benmelstobart, nivolumab, ipilimumab).
- NSCLC: Stage IV NSCLC with PD after ≥2 prior lines of systemic therapy. For patients without driver alterations: Prior treatment must include at least one ICI (e.g., pembrolizumab, camrelizumab, tislelizumab, sintilimab, atezolizumab, sugemalimab, toripalimab, penpulimab, serplulimab, nivolumab + ipilimumab, ivonescimab) and/or platinum-based chemotherapy, plus one single-agent therapy (e.g., docetaxel, pemetrexed, gemcitabine, paclitaxel, vinorelbine, anlotinib).
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- For patients with driver alterations (e.g., EGFRmutations, ALKfusions, ROS1fusions, BRAF V600mutations, NTRKfusions, METexon 14 skipping, RETalterations, KRAS G12Cmutations, or HER2mutations): Prior treatment must include at least one targeted therapy against the specific alteration and one platinum-doublet chemotherapy or single-agent therapy (as listed above). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.
- SCCHN: Metastatic head and neck squamous cell carcinoma with PD after ≥2 prior lines of systemic therapy.
- Non-nasopharyngeal carcinoma: Prior treatment must include platinum-based chemotherapy and either an ICI (e.g., pembrolizumab, finotonlimab, toripalimab, nivolumab) or an EGFR monoclonal antibody (e.g., cetuximab).
- Nasopharyngeal carcinoma: Prior treatment must include platinum-based chemotherapy and an ICI (e.g., camrelizumab, toripalimab, tislelizumab, penpulimab, tagitanlimab). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.
- r/r B-NHL: PD after ≥2 prior lines of systemic therapy. Prior treatment must include a regimen containing an approved CD20 antibody (e.g., rituximab, zuberitamab, ripertamab).
- Note: The later-line treatment status for all patients will be determined by the Investigator.
- 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).
- Laboratory Parameters: Adequate organ function within 14 days prior to enrollment, defined as:
- Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L Platelet Count (PLT) ≥ 100 × 10⁹/L Hemoglobin (HGB) ≥ 90 g/L Total Bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases or hepatocellular carcinoma) Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases or hepatocellular carcinoma) Serum Creatinine ≤ 1.5 × ULN, or Calculated Creatinine Clearance ≥ 60 mL/min (Cockcroft-Gault formula) Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN International Normalized Ratio (INR) ≤ 1.5 × ULN
- Life Expectancy: Expected survival ≥ 12 weeks.
- Contraception and Pregnancy:
- Participants of childbearing potential and their partners must agree to use highly effective non-pharmacological contraceptive methods during the study and for at least 12 weeks after the last dose.
- Female participants of childbearing potential who are not surgically sterile must have a negative serum β-human chorionic gonadotropin (β-HCG) test within 7 days prior to the first dose and must not be breastfeeding.
- Consent and Compliance: Ability to understand and voluntarily sign the ICF, and willingness to comply with scheduled visits as per protocol.
Who cannot join
- Participants meeting any of the following criteria will be ineligible for this study:
- Hypersensitivity: Known hypersensitivity to any component of the investigational product or to drugs of the same class.
- CNS Metastases:
- Patients with active central nervous system (CNS) metastases and/or carcinomatous meningitis are excluded.
- However, the following patients are allowed:
- ① Asymptomatic brain metastasis: No progressive CNS symptoms attributed to brain metastases, not requiring corticosteroids or requiring ≤ 10 mg/day prednisone (or equivalent), and lesion size ≤ 1.5 cm. These patients require regular brain imaging as a disease assessment site.
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- ② Treated brain metastases: Stable brain metastases for at least 2 months (confirmed by two imaging assessments at least 4 weeks apart post-treatment), with no evidence of new or enlarging lesions, and discontinued steroids ≥ 3 days prior to the first dose. Stability must be established prior to the first dose.
- 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.
- Valvular heart disease ≥ Grade 2 (CTCAE).
- Left ventricular ejection fraction (LVEF) < 50% as measured by echocardiogram.
- Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg); orthostatic hypotension or drug-induced hypotension (systolic BP < 90 mmHg or diastolic BP < 60 mmHg).
- Uncontrolled systemic disease despite regular treatment (e.g., diabetes).
- Prior Immune Toxicity: History of prior immunotherapy with ≥ Grade 3 immune-related adverse events (irAEs) or ≥ Grade 2 immune-mediated myocarditis.
- Coagulopathy: Hereditary bleeding diathesis or coagulopathy, or history of clinically significant bleeding disorders or arterial/venous thromboembolism (e.g., cerebrovascular events, deep vein thrombosis, pulmonary embolism) within 6 months prior to the first dose.
- Autoimmune Disease: Active autoimmune diseases such as systemic lupus erythematosus, rheumatic diseases, Crohn's disease, ulcerative colitis, etc.
- GI Perforation/Fistula: History of gastrointestinal perforation/fistula or risk factors for perforation within 6 months prior to the first dose.
- GI Bleeding: Any ≥ Grade 3 gastrointestinal bleeding within 12 weeks prior to the first dose.
- Transplantation: Prior allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Interstitial Lung Disease: History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or clinically significant active pneumonitis at screening (excluding radiation-induced fibrosis not requiring steroid treatment).
- Effusions: Uncontrollable pleural effusion, pericardial effusion, or ascites, in the judgment of the Investigator.
- Other Malignancies: History of any other active malignancy within 3 years prior to the first dose (except for curatively treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or cancers with a disease-free survival > 1 year after radical treatment).
- Surgery/Trauma: Major surgical procedure (excluding core needle biopsy) or significant traumatic injury within 4 weeks prior to the first dose, or planned elective surgery during the study period.
- Prior Anticancer Therapy: Receipt of chemotherapy, radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose. Specific washout periods:Nitrosoureas or mitomycin C (within 6 weeks); oral fluoropyrimidines or small molecule targeted drugs (within 2 weeks); traditional Chinese medicine with anti-tumor indications (within 2 weeks).
- Toxicity Recovery: Failure to recover from prior anticancer therapy toxicities to ≤ Grade 1 (per CTCAE v6.0), except for toxicities deemed safe by the Investigator (e.g., alopecia, Grade 2 peripheral neuropathy, hypothyroidism stable on hormone replacement).
- IL-2/IL-15 Agonists: Receipt of IL-2 or IL-15 agonist therapy within 4 weeks prior to the first dose.
- Immunomodulators: Receipt of immunomodulatory drugs (including but not limited to thymosin, interferon) within 2 weeks prior to the first dose.
- Corticosteroids/Immunosuppressants: Receipt of systemic corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive therapies within 2 weeks prior to the first dose. Exceptions:Use of topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; short-term prophylactic use (e.g., contrast allergy prevention).
- Tuberculosis: Active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis > 1 year ago without adequate standard treatment.
- Active Infection: Serious infection requiring intravenous antibiotics or hospitalization within 4 weeks prior to the first dose.
- Viral Infections: Active viral infections, including:
- Active hepatitis B (HBsAg or HBcAb positive and HBV DNA > upper limit of normal).
- Active hepatitis C (HCV antibody positive and HCV RNA > upper limit of normal).
- Human Immunodeficiency Virus (HIV) infection. Syphilis infection. Note: Patients receiving prophylactic antiviral therapy (excluding interferon) are permitted.
- Vaccinations: Receipt of live or attenuated live vaccines within 4 weeks prior to the first dose or anticipated receipt during the study period.
- Other: Any other severe physical or psychiatric illness, laboratory abnormality, or other condition that, in the judgment of the Investigator, would increase the risk to the participant, interfere with study results, or make participation inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100032
Yi Ba, +86-10-69158010, bayi@tjmuch.com
About this study
Official title: A Phase I Study of JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
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.
- Being tested
- JL19001, subcutaneous injection, 1 μg/kg, JL19001, subcutaneous injection, 5 μg/kg, JL19001, subcutaneous injection,10 μg/kg, JL19001, subcutaneous injection,15 μg/kg, JL19001, subcutaneous injection,20 μg/kg
- Medical subject headings
- Neoplasms, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JL19001, subcutaneous injection, 1 μg/kgDrug
JL19001, subcutaneous injection, 1 μg/kg
JL19001, subcutaneous injection, 5 μg/kgDrug
JL19001, subcutaneous injection, 5 μg/kg
JL19001, subcutaneous injection,10 μg/kgDrug
JL19001, subcutaneous injection,10 μg/kg
JL19001, subcutaneous injection,15 μg/kgDrug
JL19001, subcutaneous injection,15 μg/kg
JL19001, subcutaneous injection,20 μg/kgDrug
JL19001, subcutaneous injection,20 μg/kg
JL19001, subcutaneous injection,25 μg/kgDrug
JL19001, subcutaneous injection,25 μg/kg
| Study group | Role | What they receive |
|---|---|---|
| JL19001, subcutaneous injection, 1 μg/kg | Experimental | Not described Receives: Drug: JL19001, subcutaneous injection, 1 μg/kg |
| JL19001, subcutaneous injection, 5 μg/kg | Experimental | Not described Receives: Drug: JL19001, subcutaneous injection, 5 μg/kg |
| JL19001, subcutaneous injection, 10μg/kg | Experimental | Not described Receives: Drug: JL19001, subcutaneous injection,10 μg/kg |
| JL19001, subcutaneous injection, 15 μg/kg | Experimental | Not described Receives: Drug: JL19001, subcutaneous injection,15 μg/kg |
| JL19001, subcutaneous injection, 20 μg/kg | Experimental | Not described Receives: Drug: JL19001, subcutaneous injection,20 μg/kg |
| JL19001, subcutaneous injection, 25 μg/kg | Experimental | Not described Receives: Drug: JL19001, subcutaneous injection,25 μg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with reported Dose-limiting toxicity (DLT)
Measured: Within 28 days after the first administration
The Maximum tolerated dose (MTD)
Measured: Up to 3 years
Recommended Maximum Add-on Dose (RMAD)
Measured: Up to 3 years
Recommended Phase 2 Dose (RP2D)
Measured: Up to 3 years
The incidence of adverse events (AEs)
Measured: Up to 3 years
Secondary outcomes (18)
Determination of JL19001 concentrations
Assays were performed using an ELLISA in the central laboratory.
Measured: Up to 1 year.
Determination of lymphocyte cell counts in blood.
Measured: Up to 1 year.
Determination of CD4+T cell counts in blood.
Measured: Up to 1 year.
Determination of CD8+T cell counts in blood.
Measured: Up to 1 year.
Determination of NK cell counts in blood.
Measured: Up to 1 year.
Measurement of IL-2 in the blood.
Measured: Up to 1 year.
Measurement of IL-4 in the blood.
Measured: Up to 1 year.
Measurement of IL-6 in the blood.
Measured: Up to 1 year.
Measurement of IL-8 in the blood.
Measured: Up to 1 year.
Measurement of IL-10 in the blood.
Measured: Up to 1 year.
Measurement of TNF-α in the blood.
Measured: Up to 1 year.
Measurement of IFN-γ in the blood.
Measured: Up to 1 year.
Detect anti-JL19001 antibodies in serum
Measured: Up to 3 years
Objective response rate (ORR)
Measured: Up to 3 years
Disease control rate (DCR)
Measured: Up to 3 years
Duration of response (DOR)
Measured: Up to 3 years
Progression-free survival (PFS)
Measured: Up to 3 years
Overall survival (OS)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start25 Jun 2026
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jecho Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603479
- Sponsor's protocol ID
- JL19001-AST&NHL-101
- Status last verified
- Aug 2026
- First submitted
- 18 May 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07603479
- Acronym / sponsor ID
- JL19001-AST&NHL-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Jecho Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| JL19001, subcutaneous injection, 1 μg/kg | Experimental | Drug: JL19001, subcutaneous injection, 1 μg/kg |
| JL19001, subcutaneous injection, 5 μg/kg | Experimental | Drug: JL19001, subcutaneous injection, 5 μg/kg |
| JL19001, subcutaneous injection, 10μg/kg | Experimental | Drug: JL19001, subcutaneous injection,10 μg/kg |
| JL19001, subcutaneous injection, 15 μg/kg | Experimental | Drug: JL19001, subcutaneous injection,15 μg/kg |
| JL19001, subcutaneous injection, 20 μg/kg | Experimental | Drug: JL19001, subcutaneous injection,20 μg/kg |
| JL19001, subcutaneous injection, 25 μg/kg | Experimental | Drug: JL19001, subcutaneous injection,25 μg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- Melanoma: Advanced cutaneous or acral melanoma with progressive disease (PD) after ≥2 prior lines of systemic therapy. Prior treatment must include at least one immune checkpoint inhibitor (ICI; e.g., pembrolizumab, toripalimab, pucotenlimab, ipilimumab + nivolumab, atezolizumab) and at least one chemotherapy (e.g., dacarbazine, temozolomide, paclitaxel, nab-paclitaxel, cisplatin/carboplatin, fotemustine). For patients with BRAF V600, NRAS, or KITmutations, prior treatment must include at least one targeted therapy against the specific mutation and one ICI (as listed above). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.
- RCC: Metastatic or unresectable clear cell RCC with PD after ≥1 prior line of therapy or intolerance to ≥1 prior line. Prior treatment must include at least one targeted therapy (e.g., sunitinib, pazopanib, sorafenib, axitinib, lenvatinib, anlotinib, vorolanib + everolimus) and one ICI (e.g., toripalimab, pembrolizumab, benmelstobart, nivolumab, ipilimumab).
- NSCLC: Stage IV NSCLC with PD after ≥2 prior lines of systemic therapy. For patients without driver alterations: Prior treatment must include at least one ICI (e.g., pembrolizumab, camrelizumab, tislelizumab, sintilimab, atezolizumab, sugemalimab, toripalimab, penpulimab, serplulimab, nivolumab + ipilimumab, ivonescimab) and/or platinum-based chemotherapy, plus one single-agent therapy (e.g., docetaxel, pemetrexed, gemcitabine, paclitaxel, vinorelbine, anlotinib).
Key exclusion criteria (39 listed)
- Hypersensitivity: Known hypersensitivity to any component of the investigational product or to drugs of the same class.
- CNS Metastases:
- Patients with active central nervous system (CNS) metastases and/or carcinomatous meningitis are excluded.
- ① Asymptomatic brain metastasis: No progressive CNS symptoms attributed to brain metastases, not requiring corticosteroids or requiring ≤ 10 mg/day prednisone (or equivalent), and lesion size ≤ 1.5 cm. These patients require regular brain imaging as a disease assessment site.
- ② Treated brain metastases: Stable brain metastases for at least 2 months (confirmed by two imaging assessments at least 4 weeks apart post-treatment), with no evidence of new or enlarging lesions, and discontinued steroids ≥ 3 days prior to the first dose. Stability must be established prior to the first dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JL19001, subcutaneous injection, 1 μg/kgJL19001, subcutaneous injection, 1 μg/kg | Drug | JL19001, subcutaneous injection, 1 μg/kg |
| JL19001, subcutaneous injection, 5 μg/kgJL19001, subcutaneous injection, 5 μg/kg | Drug | JL19001, subcutaneous injection, 5 μg/kg |
| JL19001, subcutaneous injection,10 μg/kgJL19001, subcutaneous injection,10 μg/kg | Drug | JL19001, subcutaneous injection, 10μg/kg |
| JL19001, subcutaneous injection,15 μg/kgJL19001, subcutaneous injection,15 μg/kg | Drug | JL19001, subcutaneous injection, 15 μg/kg |
| JL19001, subcutaneous injection,20 μg/kgJL19001, subcutaneous injection,20 μg/kg | Drug | JL19001, subcutaneous injection, 20 μg/kg |
| JL19001, subcutaneous injection,25 μg/kgJL19001, subcutaneous injection,25 μg/kg | Drug | JL19001, subcutaneous injection, 25 μg/kg |
Primary outcome
Number of participants with reported Dose-limiting toxicity (DLT)
Time frame: Within 28 days after the first administration
The Maximum tolerated dose (MTD)
Time frame: Up to 3 years
Recommended Maximum Add-on Dose (RMAD)
Time frame: Up to 3 years
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 3 years
The incidence of adverse events (AEs)
Time frame: Up to 3 years
18 secondary outcomes
Determination of JL19001 concentrations
Time frame: Up to 1 year.
Determination of lymphocyte cell counts in blood.
Time frame: Up to 1 year.
Determination of CD4+T cell counts in blood.
Time frame: Up to 1 year.
Determination of CD8+T cell counts in blood.
Time frame: Up to 1 year.
Determination of NK cell counts in blood.
Time frame: Up to 1 year.
Measurement of IL-2 in the blood.
Time frame: Up to 1 year.
Measurement of IL-4 in the blood.
Time frame: Up to 1 year.
Measurement of IL-6 in the blood.
Time frame: Up to 1 year.
Measurement of IL-8 in the blood.
Time frame: Up to 1 year.
Measurement of IL-10 in the blood.
Time frame: Up to 1 year.
Measurement of TNF-α in the blood.
Time frame: Up to 1 year.
Measurement of IFN-γ in the blood.
Time frame: Up to 1 year.
Detect anti-JL19001 antibodies in serum
Time frame: Up to 3 years
Objective response rate (ORR)
Time frame: Up to 3 years
Disease control rate (DCR)
Time frame: Up to 3 years
Duration of response (DOR)
Time frame: Up to 3 years
Progression-free survival (PFS)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JL19001, subcutaneous injection, 1 μg/kg, JL19001, subcutaneous injection, 5 μg/kg and JL19001, subcutaneous injection,10 μg/kg in people with Malignancies and Solid Malignant Tumor, run by Jecho Biopharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongwei Ms Liu (+86 18814668239, hongwei.liu@jechobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with reported Dose-limiting toxicity (DLT) (time frame: Within 28 days after the first administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.