Actively Recruiting
A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-11-08
48
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
Sponsors
C
Chongqing Precision Biotech Co., Ltd
Lead Sponsor
T
The First Affiliated Hospital of Nanchang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center, double-arm, open-label study. this study plans to evaluate the safety and efficacy of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced/metastatic solid tumors, and obtain recommended doses and infusion patterns.
CONDITIONS
Official Title
A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Advanced or metastatic solid tumor confirmed by tissue testing with positive CD70 expression
- Tumor unresponsive or intolerant to prior treatments including TKI, PARP inhibitors, anti-vascular drugs, surgery, chemotherapy, radiotherapy, or targeted therapy
- At least one measurable lesion as defined by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Expected survival time of more than 12 weeks
- No serious mental disorders
- Normal functioning of important organs including blood, heart, kidneys, liver, and oxygen saturation above 92% without oxygen
- Ability to undergo blood collection for apheresis without contraindications
- Willingness to use effective contraception for one year after CAR-T infusion
- Informed consent signed indicating understanding and willingness to participate
You will not qualify if you...
- Previous treatment with anti-CD70 drugs before screening
- Active or symptomatic brain or meningeal metastases; treated brain metastases must show no progression for at least 4 weeks
- Participation in other interventional clinical trials within 3 months for unmarketed drugs or within 5 half-lives for marketed drugs
- Anti-tumor treatments like chemotherapy or targeted therapy within 2 weeks prior to apheresis
- Systemic corticosteroid therapy above 10 mg/day prednisone equivalent within 2 weeks before apheresis
- Live attenuated vaccine within 4 weeks before screening
- Active or uncontrolled infections needing systemic treatment within 1 week before screening
- Other malignant tumors within 3 years except certain treated cancers without active disease
- Severe heart conditions including advanced heart failure, recent myocardial infarction or coronary surgery, serious arrhythmias, or severe cardiomyopathy
- Active or uncontrolled autoimmune diseases such as Crohn's disease, rheumatoid arthritis, lupus, or vasculitis
- Positive tests for certain viral infections including hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus
- Recent venous thromboembolic events or serious bleeding conditions
- Poorly controlled high blood pressure above 150/90 mmHg unless stabilized with treatment
- Pregnancy, breastfeeding, or plans to have children within one year after CAR-T infusion
- Any other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
F
Fei Li, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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