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

NCT07603479 | Not Yet Recruiting Phase 1

• 1 other identifier: JL19001-AST&NHL-101
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Malignancies; Solid Malignant Tumor; NHL (Non-Hodgkin Lymphoma); Solid Tumor Cancer

Outcome Measures

Primary Outcomes (5)

• Number of participants with reported Dose-limiting toxicity (DLT)

  Within 28 days after the first administration

• The Maximum tolerated dose (MTD)

  Up to 3 years

• Recommended Maximum Add-on Dose (RMAD)

  Up to 3 years

• Recommended Phase 2 Dose (RP2D)

  Up to 3 years

• The incidence of adverse events (AEs)

  Up to 3 years

Secondary Outcomes (18)

• Determination of JL19001 concentrations

  Up to 1 year.

• Determination of lymphocyte cell counts in blood.

  Up to 1 year.

• Determination of CD4+T cell counts in blood.

  Up to 1 year.

• Determination of CD8+T cell counts in blood.

  Up to 1 year.

• Determination of NK cell counts in blood.

  Up to 1 year.

Study Arms (6)

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

Interventions

JL19001, subcutaneous injection, 1 μg/kg DRUG

JL19001, subcutaneous injection, 1 μg/kg

JL19001, subcutaneous injection, 1 μg/kg

JL19001, subcutaneous injection, 5 μg/kg DRUG

JL19001, subcutaneous injection, 5 μg/kg

JL19001, subcutaneous injection, 5 μg/kg

JL19001, subcutaneous injection,10 μg/kg DRUG

JL19001, subcutaneous injection,10 μg/kg

JL19001, subcutaneous injection, 10μg/kg

JL19001, subcutaneous injection,15 μg/kg DRUG

JL19001, subcutaneous injection,15 μg/kg

JL19001, subcutaneous injection, 15 μg/kg

JL19001, subcutaneous injection,20 μg/kg DRUG

JL19001, subcutaneous injection,20 μg/kg

JL19001, subcutaneous injection, 20 μg/kg

JL19001, subcutaneous injection,25 μg/kg DRUG

JL19001, subcutaneous injection,25 μg/kg

JL19001, subcutaneous injection, 25 μg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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:

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Jecho Biopharmaceuticals Co., Ltd.: lead

MeSH Terms

Conditions

Neoplasms; Lymphoma, Non-Hodgkin

Interventions

Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05