Actively Recruiting
A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors
Led by Fudan University · Updated on 2024-05-01
12
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC729 in the treatment of advanced malignant solid tumors. Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I
CONDITIONS
Official Title
A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- ECOG performance status of 0 or 1
- Expected survival time longer than 3 months
- Advanced malignant solid tumor confirmed by histology or cytology, recurrent or metastatic after at least second-line treatment
- Tumor is CD70 positive by immunohistochemistry
- At least one measurable tumor lesion at baseline per RECIST version 1.1
- Adequate organ function including hematopoietic, renal, liver function, and coagulation parameters
- Negative pregnancy test for women of childbearing age
- Agreement to use effective contraception for both men and women
- Signed informed consent indicating understanding and willingness to participate
You will not qualify if you...
- Received cell therapy within the previous one month
- Risk of severe bleeding in esophageal cancer
- Other malignant tumors within past 2 years except certain cured skin, bladder, or breast cancers
- Leptomeningeal or central nervous system metastasis or significant CNS disease symptoms in past 6 months
- Immunotherapy, targeted therapy, or chemotherapy within 2 weeks before cell infusion
- Active hepatitis B, HIV positive, or hepatitis C positive
- Active or uncontrolled infections
- NYHA heart failure class 2 or higher, uncontrolled hypertension, recent myocarditis or myocardial infarction within 6 months
- Unstable respiratory diseases including interstitial pneumonia
- Uncontrolled ascites or pleural effusion
- Active or uncontrolled autoimmune diseases like Crohn's disease, rheumatoid arthritis, or lupus
- Use of systemic steroids or steroid inhalers
- Pregnant or lactating females
- Any condition deemed unsuitable for study participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
Jian 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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