Actively Recruiting
A Phase I Study to Evaluate the Safety and Tolerability of JLM019 Injection in Patients With Advanced Malignancies
Led by Jecho Biopharmaceuticals Co., Ltd. · Updated on 2026-06-03
115
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of JLM019 Injection in adults with advanced malignancies, including advanced solid tumors and relapsed or refractory Hodgkin and Non-Hodgkin lymphomas. This is a phase 1, multicenter, single-arm, open-label study with dose escalation and dose expansion phases. The study aims to identify the recommended dose for combination therapy, assess dose-limiting toxicities, and monitor adverse events over time. Participants will receive JLM019 Injection through intravenous infusion at doses ranging from 0.001 to 10 mg/kg. The infusion lasts at least 30 minutes and is scheduled once weekly in 28-day treatment cycles. Dose escalation follows an accelerated titration and a traditional 3 + 3 design, adjusting dose and interval based on pharmacokinetics, pharmacodynamics, and safety data. Treatment continues until disease progression, intolerable toxicity, need for new therapy, withdrawal, death, loss to follow-up, or other reasons. During the study, researchers will monitor safety through adverse event reports and laboratory tests, analyze drug levels and immune responses, and evaluate treatment efficacy using tumor assessments. Participants may undergo biopsies and imaging scans as scheduled. The study includes long-term follow-up for progression-free survival, duration of response, and overall survival up to 15 years. The total participation time varies based on individual treatment duration and follow-up assessments.
CONDITIONS
Brief Title
A Phase I Study of JLM019 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histopathologically or cytologically confirmed advanced solid tumors or relapsed/refractory Hodgkin's/Non-Hodgkin's lymphomas
- Measurable disease defined by CT or PET-CT scans with specific lesion size requirements
- Prioritized molecular profiles including high tumor T-cell infiltration or specific genetic markers
- Submission of tumor biopsy representative of current disease
- Willingness to undergo on-study biopsy if tumors accessible
- ECOG performance status grade 0 to 1
- Life expectancy of at least 3 months
- Recovery to Grade 1 or less for non-laboratory toxicities from prior therapy (exceptions apply)
- Adequate hematologic, renal, hepatic, and cardiac function based on laboratory values
- Agreement to use effective contraception during and 4 months after the trial
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Allergy to components of JLM019 Injection
- History of severe infusion-related or allergic reactions to monoclonal antibody or Fc-based therapies
- Previous serious cardiovascular immune-related adverse events or treatment discontinuation due to such events
- Serious or uncontrolled conditions such as recent infections, vascular diseases, uncontrolled hypertension, active thrombosis or bleeding risk
- Active autoimmune disease requiring systemic treatment (replacement therapy allowed)
- Serious cardiovascular conditions including recent myocarditis, heart failure, or abnormal heart function
- History or current pneumonitis or interstitial lung disease
- Active central nervous system metastases unless treated and stable
- Prior organ transplant or recent stem cell transplant without clearance
- Recent use of checkpoint inhibitors, chemotherapy, monoclonal antibodies, or radiation within specified timeframes
- Participation in another clinical trial within 4 weeks prior to dosing
- Need for systemic corticosteroids or immunosuppressive medication within 14 days prior to dosing
- Receipt of live or live-attenuated vaccine within 30 days prior to dosing
- Recent radiotherapy or history of radiation pneumonitis
- Second active malignancy within 3 years except certain treated skin or cervical cancers
- History of AIDS, syphilis, or active hepatitis with elevated viral markers
- Pregnancy or lactation or positive pregnancy test within 7 days prior to dosing
- Any condition deemed unsuitable for participation by the Investigator or Sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated once weekly until discontinuation conditions occur
Participants receive JLM019 Injection administered via intravenous infusion once weekly. Each infusion lasts at least 30 minutes. Treatment continues until disease progression, intolerable toxicity, need for new therapy, withdrawal, death, loss to follow-up, or other protocol-specified discontinuation.
Weekly visits for infusion and assessments
Duration - Up to 15 years
Participants are monitored for long-term safety, efficacy, and survival outcomes after treatment ends.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
H
hailong zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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