Actively Recruiting
A Phase I Study on ReT01 ACT for the Treatment of Advanced Solid Tumors
Led by Aeonvital Biomedicine · Updated on 2024-07-31
15
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-armed, open, phase I study was designed to evaluate the safety and tolerance of ReT01 ACT injection in the treatment of advanced solid tumors. The phase I clinical trial is expected to be finished in 1 year.
CONDITIONS
Official Title
A Phase I Study on ReT01 ACT for the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agreed to complete study procedures and follow-up
- Age between 18 and 75 years, any gender
- ECOG performance status score of 0 or 1
- Histologically or cytologically confirmed advanced solid tumors positive for PAN-CK that have failed previous standard therapy or lack standard treatment options
- At least one eligible tumor lesion or tissue available for ReT01 ACT preparation with sufficient tumor volume
- Predicted survival time of at least 3 months
- At least one measurable tumor lesion after tumor tissue sampling according to RECIST 1.1 criteria
- Good organ function with specific blood counts and liver and kidney tests within defined limits
- Toxic effects from previous therapies resolved to grade 1 or less, except some neurotoxicity
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception for 6 months post-enrollment
- Trial protocol approval and adherence as judged by investigators
You will not qualify if you...
- Only bone metastases present
- Presence of central nervous system metastases
- Previous treatment with other adoptive cell therapies
- Systemic anti-tumor therapy within 3 weeks before conditioning
- Use of Chinese/herbal medicine with anti-tumor effects within 1 week before pretreatment
- Use of prednisone 10 mg or higher daily or other immunosuppressants within 2 weeks before conditioning
- Major surgery within 4 weeks before screening, except surgery for ReT01 ACT cell preparation
- Other malignant tumors within 5 years before screening, except certain low-risk treated tumors
- History of active or suspected autoimmune or inflammatory diseases
- Previous organ or hematopoietic stem cell transplantation
- Active infections including hepatitis B or C, systemic infections requiring antibiotics, or immunodeficiency
- Vaccination with live or attenuated vaccine within 4 weeks before conditioning
- Severe cardiovascular or cerebrovascular diseases, uncontrolled hypertension, heart failure, severe arrhythmias
- Severe respiratory diseases including severe lung disease or low lung function
- History of neurological or psychiatric disorders such as epilepsy or dementia
- Severe allergic reactions to study drugs or related medications
- Any other condition judged unsuitable by investigators, including severe adverse effects from prior immunotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
X
Xiujun Zhang
CONTACT
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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