A Phase I Study of JLM019 Injection

NCT07623850 | Recruiting Phase 1

• 1 other identifier: JLM019-001
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, single-arm, open-label, dose escalation phase (Part A) and dose expansion (Part B) study to evaluate the safety and tolerability of JLM019 Injection in patients with advanced malignancies. The study subjects are adults with advanced malignancies including advanced solid tumors or relapsed/refractory lymphoma. During the dose escalation phase, the dose escalation scheme is the accelerated titration in 0.001 - 0.2 mg/kg cohorts plus a traditional '3 + 3' design in 0.6 - 10 mg/kg cohorts, jointly in nine dose cohorts 0.001, 0.01, 0.05, 0.2, 0.6, 1.5, 3, 6 and 10 mg/kg. JLM019 Injection is intended to be administered once a week (QW). However, the dose and interval of administration may be adjusted based on the acquired PK, PD, and safety data. Each treatment cycle is 28 days.The repeated dose is tentatively scheduled to be administered once weekly until one of the following occurs: disease progression, intolerable toxicity, requirement for new antitumor therapy, withdrawal of informed consent form, death, loss to follow-up, or other protocol-specified discontinuation conditions. Safety profile, DLT, MTD and RED of JLM019 Injection shall be assessed during and after treatment, with PK, PD, immunogenicity and Efficacy analyzed correspondingly.

Conditions

Advanced Solid Tumor (Phase 1); Non-Hodgkin Lymphoma; Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (3)

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

  Evaluate according to the DLT standards specified in the protocol

  Within 28 days after the first dose

• Rate of adverse events

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

  Up to 3 years

• Determine the recommended dose for combination for JLM019 injection

  Evaluate the data from the Phase Ia study to determine recommended dose for combination for JLM019 injection in Phase Ib

  Up to 3 years

Secondary Outcomes (9)

• Determination of JLM019 concentrations

  Up to 12 months

• Detection of anti-JLM019 antibodies in serum

  Up to 12 months

• Determination of detailed blood lymphocyte subsets

  Up to 12 months

• Determination of cytokines in blood

  Up to 12 months

• Objective response rate

  Up to 12 months

Study Arms (1)

JLM019 Injection

EXPERIMENTAL

The JLM019 Injection will be administered via intravenous (IV) infusion at dose levels of 0.001, 0.01, 0.05, 0.2, 0.6, 1.5, 3, 6, and 10 mg/kg. Each IV infusion must last at least 30 min. The repeated dose is tentatively scheduled to be administered once weekly until one of the following occurs: disease progression, intolerable toxicity, requirement for new antitumor therapy, withdrawal of informed consent form, death, loss to follow-up, or other protocol-specified discontinuation conditions. (Note: The dose and administration interval may be adjusted based on acquired PK, PD and safety data).

Biological: JLM019 Injection

Interventions

JLM019 Injection BIOLOGICAL

The JLM019 Injection will be administered via intravenous (IV) infusion at dose levels of 0.001, 0.01, 0.05, 0.2, 0.6, 1.5, 3, 6, and 10 mg/kg. Each IV infusion must last at least 30 min. The repeated dose is tentatively scheduled to be administered once weekly until one of the following occurs: disease progression, intolerable toxicity, requirement for new antitumor therapy, withdrawal of informed consent form, death, loss to follow-up, or other protocol-specified discontinuation conditions. (Note: The dose and administration interval may be adjusted based on acquired PK, PD and safety data).

JLM019 Injection

Eligibility Criteria

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

You may qualify if:

• Eighteen years of age or older;
• Patients with histopathologically or cytologically confirmed advanced solid tumors (AST) or relapsed/refractory (r/r) Hodgkin's/Non-Hodgkin's lymphomas (HL/NHL, including transformed lymphomas):
• AST subtypes include but are not limited: colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC), gastric cancer (GC), ovarian cancer (OV), renal cell carcinoma (RCC), melanoma, biliary tract cancer (BTC), alveolar soft part sarcoma (ASPS), etc.
• HL/NHL subtypes include but are not limited: classical Hodgkin lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), mantle cell lymphoma (MCL), etc.
• Measurable disease as defined as:
• AST: At least one tumor lesion ≥ 10 mm in the longest diameter as assessed by computed tomography (CT);
• HL/NHL: Fluorodeoxyglucose (FDG) avid disease by positron emission tomography (PET) and ≥ 1 lesion \> 15 mm in the longest diameter by \> 10 mm in the short axis, as assessed by CT;
• Patients with the following molecular profiles will be prioritized for enrollment:
• High tumor T-cell infiltration (e.g., elevated T-cell GEP score);
• TMB \> 10 mut/Mb、MSI-H/dMMR status or POLE/POLD1 mutations. Absence of β2M and JAK1/JAK2 loss-of-function mutations.
• Submission of tumor biopsy representative of the current disease, which may consist of any of the following:
• Archived formalin-fixed paraffin-embedded (FFPE) tissue block;
• At least 15-20 slides of tumor tissue from an FFPE block suitable for immunohistochemistry (IHC), including ≥ 10 % tumor content per section with ≥ 20 mm2 of evaluable tissue which may include ≤ 50 % tumor adjacent tissue;
• A fresh tumor biopsy obtained by surgical excision or core needle procedure prior to the first dose of JLM019 Injection;
• For patients with accessible tumors, willingness to undergo on-study biopsy as scheduled in the protocol;

You may not qualify if:

• Allergy to JLM019 Injection components;
• History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous monoclonal antibody or other Fc-based protein therapy;
• Experienced any cardiovascular immune-related adverse event (irAE), or discontinued from that treatment due to a Grade 3 or higher irAE in previous ICI therapy;
• Any serious or uncontrolled health conditions listed below:
• Patients with concurrent infections requiring intravenous antimicrobial therapy within the past 2 weeks, or with unexplained fever (body temperature ≥ 37.5 °C);
• History of vascular diseases within the past 6 months (including myocardial infarction, unstable angina, cerebrovascular diseases, and peripheral arterial or aortic diseases);
• Uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on at least two separate occasions after antihypertensive treatment);
• Individuals with active thrombosis, active bleeding, or pathological conditions associated with high bleeding risk (such as coagulation disorders);
• Has an active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment;
• Any serious or uncontrolled cardiovascular condition, including but not necessarily limited to:
• Any history of myocarditis of any etiology;
• History of New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, cerebrovascular accident, cardiac hospitalization, or other acute uncontrolled heart disease within 6 months of scheduled C1D1;
• Left ventricular ejection fraction \< 45 % on screening echocardiogram;
• Any clinically significant findings on screening EKG such as atrial or ventricular arrythmia (other than sinus tachycardia) or AV conduction abnormality such as left bundle branch block (such patients may be enrolled after cardiology clearance and Sponsor approval);
• History of (non-infectious) pneumonitis / interstitial lung disease or current pneumonitis / interstitial lung disease;

Sponsors & Collaborators

• Jecho Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

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

Central Study Contacts

hailong zhang

CONTACT

+8613332000582; hailong.zhang@jechobio.com

Study Design

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

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 3, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): March 14, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

CN (1)