Actively Recruiting
Clinical Study of CD70-Targeted CAR-T Therapy in Advanced CD70-Positive Malignant Solid Tumors
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-10-02
90
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of a new type of treatment called CD70-targeted CAR-T cell therapy in adults with advanced solid tumors that express the CD70 protein. This open-label, phase 1 study aims to determine how the treatment behaves in the body, the best dose, and infusion schedule for patients with advanced cancers such as renal cell carcinoma, lung cancer, anaplastic thyroid carcinomas, ovarian cancer, cervical cancer, and thymic carcinoma. Participants will be assigned to one of three groups based on how the CAR-T cells are infused: intravenously, into the pleural space, or into the peritoneal cavity. The study has two parts within each group: a dose-escalation phase where increasing doses are tested in small groups, and a dose-expansion phase where more patients receive the selected dose to better assess safety and early signs of effectiveness. Before receiving CAR-T cell infusions, patients undergo conditioning therapy with Fludarabine and Cyclophosphamide. During the study, participants will be closely monitored for safety and side effects for at least one month after infusion. Researchers will also assess disease control at one and three months, study how the CAR-T cells move and persist in the body, and observe inflammatory responses following treatment. Participants will have regular assessments, including clinical exams and laboratory tests, to evaluate treatment effects and safety throughout the study duration.
CONDITIONS
Brief 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, any gender
- Histologically or cytologically confirmed advanced or metastatic solid tumors with positive CD70 expression (IHC 3+ score)
- Failed or intolerant to standard second-line treatments including TKIs, PARPi, anti-angiogenic therapy, or unable to tolerate surgery, chemotherapy, radiotherapy, or targeted therapy
- At least one measurable lesion by RECIST 1.1 criteria on CT scan
- ECOG performance status between 0 and 2
- Expected survival of at least 12 weeks
- No history of severe psychiatric disorders
- Adequate organ function including defined blood counts, cardiac, renal, hepatic function, and oxygen saturation
- Ability to undergo blood collection for cellular therapy
- Women must agree to reliable contraception from consent through 1 year after infusion
- Informed consent signed by participant or authorized guardian
You will not qualify if you...
- Prior treatment with anti-CD70 therapies
- Active or symptomatic central nervous system metastases or meningeal metastases unless treated and stable for at least 4 weeks
- Recent participation in other interventional trials or recent chemotherapy/targeted therapy within specified time frames
- Recent use of high-dose steroids unless for adrenal replacement or local use
- Recent live attenuated vaccine within 4 weeks
- Active or uncontrolled infections requiring treatment
- History of other malignancies within 3 years except certain non-melanoma skin cancers or cured malignancies
- Severe cardiovascular conditions including advanced heart failure, recent heart attack or bypass surgery, significant arrhythmias, or cardiomyopathy
- Active or uncontrolled autoimmune diseases
- Positive tests for certain infections including hepatitis B, C, HIV, or syphilis
- Unresolved toxicity from prior anti-tumor treatments except alopecia or peripheral neuropathy
- History of venous thromboembolism requiring ongoing anticoagulation or severe bleeding complications
- Pregnant or breastfeeding women
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants receive conditioning therapy with Fludarabine and Cyclophosphamide before infusion of CD70-targeted CAR-T cells by intravenous, intrapleural, or intraperitoneal methods.
1 infusion visit plus multiple monitoring visits during treatment
Duration - Up to 3 months
Participants are monitored for safety, effectiveness, and inflammatory response after CAR-T cell infusion.
Weekly visits for up to 3 months
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
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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