Actively Recruiting
CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-10-02
90
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CD70-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CD70-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CD70-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
CONDITIONS
Official Title
CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological or cytological confirmation of advanced or metastatic solid tumors with positive CD70 expression (IHC 3+ score)
- Failed or intolerant to standard second-line treatments including TKIs, PARP inhibitors, or anti-angiogenic therapy
- At least one measurable lesion per RECIST 1.1 criteria (extranodal lesion ≥10mm, lymph node lesion ≥15mm, CT slice thickness ≤5mm)
- ECOG performance status between 0 and 2
- Expected survival of at least 12 weeks
- No history of severe psychiatric disorders
- Adequate organ function including specific blood counts, heart function, kidney and liver function, and oxygen saturation ≥92% without oxygen support
- Ability to undergo blood collection for cellular therapy
- Female participants must agree to use reliable contraception from consent until one year after treatment
- Signed informed consent form with understanding of study purpose and procedures
You will not qualify if you...
- Previous treatment with anti-CD70 therapies
- Active or symptomatic central nervous system or meningeal metastases, except treated brain metastases completed at least 4 weeks prior without progression
- Participation in other interventional trials within 3 months before infusion, with longer intervals for unapproved drugs
- Chemotherapy or targeted therapy within 2 weeks prior to blood collection or within 5 drug half-lives
- Use of prednisone over 10mg/day in the 2 weeks before blood collection (exceptions for adrenal replacement or inhaled steroids)
- Receipt of live attenuated vaccines within 4 weeks prior to screening
- Active infection requiring systemic treatment or uncontrolled infection within 1 week before screening
- History of other malignancy within 3 years except treated stable non-melanoma skin cancer or other cured malignancies without active disease for 3 years
- Severe cardiovascular conditions including NYHA Class III/IV heart failure, recent myocardial infarction or bypass surgery, significant arrhythmias, or severe cardiomyopathy
- Active or uncontrolled autoimmune diseases such as Crohn's disease, rheumatoid arthritis, lupus, or vasculitis
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with active infection
- Unresolved toxicity from prior anti-tumor treatments above grade 1 except alopecia or peripheral neuropathy
- History of venous thromboembolism requiring ongoing anticoagulation or with severe bleeding or post-thrombotic symptoms
- Pregnant or breastfeeding women
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The 901 Hospital of Joint Logistics Support Force of People Liberation Army
Hefei, Anhui, China, 230031
Actively Recruiting
Research Team
D
Donglai Lv, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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