Actively Recruiting
Safety and Tolerability Evaluation of CEL001 Injection in Advanced Solid Tumors
Led by Guangzhou Xiling Biotechnology Co., Ltd. · Updated on 2025-12-02
13
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is the first human, open label, dose escalation, and expansion phase I clinical trial aimed at evaluating the safety, tolerability, preliminary efficacy, pharmacokinetic characteristics, biomarker changes, and immunogenicity of CEL001 injection in the treatment of advanced solid tumors.
CONDITIONS
Official Title
Safety and Tolerability Evaluation of CEL001 Injection in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- ECOG physical fitness status score of 0-1
- Diagnosed with advanced or metastatic tumors by histology or cytology
- Prior standard treatments have failed or are not tolerated according to CSCO or NCCN guidelines
- Male weight at least 50 kilograms and female weight at least 45 kilograms
- Expected survival time longer than 3 months
- At least one measurable lesion according to RECIST 1.1 standard
- Adequate organ function including blood counts, kidney, liver, and coagulation as specified
- Women must use effective contraception during study and for 6 months after, have a negative pregnancy test within 7 days before enrollment, and not be breastfeeding
- Men must agree to use effective contraception during study and for 6 months after
You will not qualify if you...
- Allergy to any component of CEL001 injection including penicillin
- Received anti-tumor treatments or participated in other clinical trials within 4 weeks or 5 drug half-lives before first dose
- Used traditional or modern Chinese medicine with anti-tumor effects within 14 days before first dose
- History of other malignant tumors within past 5 years except certain cured cancers
- Unresolved adverse reactions from prior treatments above grade 1 (except hair loss)
- Surgery within 4 weeks prior to treatment or not fully recovered from invasive procedures
- Uncontrolled central nervous system or meningeal metastasis
- Active or suspected infection with severity grade 2 or higher
- History of autoimmune diseases, immunodeficiency, HIV positive, or organ transplantation
- Active hepatitis B or C infection
- Previous immunotherapy treatment
- Serious cardiovascular disease or history including severe arrhythmias, recent myocardial infarction, heart failure NYHA grade II or above, low ejection fraction, abnormal QT intervals, or severe cerebrovascular disease
- Need for concurrent anti-tumor treatments during study
- History of neurological or mental disorders such as epilepsy or dementia
- Any other reasons judged by researchers to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China, 100021
Actively Recruiting
Research Team
L
Li Ning, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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