Status:
RECRUITING
CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors
Lead Sponsor:
Chongqing Precision Biotech Co., Ltd
Conditions:
Renal Cell Carcinoma (RCC)
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 obser...
Detailed Description
According to the different infusion methods, patients will be assigned to three parallel subgroups: intravenous infusion, intrapleural infusion, and intraperitoneal infusion. Within each subgroup, th...
Eligibility Criteria
Inclusion
- Age ≥18 years, regardless of gender;
- Histologically or cytologically confirmed advanced/metastatic solid tumors (tumors with positive CD70 expression, confirmed histopathological ly with IHC 3+ score);
- Failed or intolerant to standard second-line treatments (at least one of the following: tyrosine kinase inhibitors (TKIs), poly(ADP-ribose) polymerase inhibitors (PARPi), anti-angiogenic therapy; disease progression or inability to tolerate surgery, chemotherapy, radiotherapy, or targeted therapy);
- At least one measurable lesion per RECIST 1.1 criteria, with measurable lesions defined as:
- Extranodal lesions with a long axis ≥10mm on CT scan;
- Lymph node lesions with a short axis ≥15mm on CT scan;
- CT slice thickness ≤5mm.
- ECOG performance status of 0-2 ;
- Expected survival ≥12 weeks;
- No history of severe psychiatric disorders;
- Adequate organ function as defined by the following:
- Hematology: White blood cell count \>2.0×10⁹/L, neutrophils \>0.8×10⁹/L, lymphocytes \>0.5×10⁹/L, platelets \>50×10⁹/L, hemoglobin \>90g/L;
- Cardiac: Echocardiogram showing left ventricular ejection fraction (LVEF) ≥50%, and ECG with no significant abnormalities;
- Renal: Serum creatinine ≤2.0×ULN;
- Hepatic: ALT and AST ≤3.0×ULN (may be relaxed to ≤5.0×ULN in cases with liver tumor infiltration); total bilirubin ≤2.0×ULN (may be relaxed to ≤3.0×ULN in cases with Gilbert's syndrome or liver tumor infiltration);
- Oxygen saturation ≥92% without supplemental oxygen;
- Ability to undergo single or venous blood collection, with no contraindications to cellular collection;
- Female subjects must agree to use reliable contraception (excluding fertility awareness methods) from the time of informed consent until 1 year after CAR-T cell infusion;
- Subject or authorized guardian agrees to participate in the trial and signs the informed consent form (ICF), indicating understanding of the trial's purpose and procedures and willingness to participate.
Exclusion
- Prior treatment with anti-CD70 therapies;
- Active/symptomatic central nervous system (CNS) metastasis or meningeal metastasis: Subjects with treated brain metastases are eligible if treatment was completed ≥4 weeks prior to screening and there is no evidence of progression on imaging;
- Prior treatments within specified time frames:
- Participation in other interventional clinical trials within 3 months before cell infusion (for unapproved drugs, the last dose must be ≥3 months prior; for approved drugs, ≥5 half-lives prior to cell infusion);
- Received chemotherapy or targeted therapy within 2 weeks prior to blood collection or within 5 half-lives of the drug (whichever is shorter);
- Received \>10mg/day prednisone (or equivalent) within 2 weeks prior to blood collection, unless for adrenal replacement or inhaled/local steroids (except for active autoimmune disease);
- Received live attenuated vaccines within 4 weeks prior to screening;
- Active infection requiring systemic treatment or uncontrolled infection within 1 week before screening;
- History of any other malignancy within the past 3 years, except for treated and stable non-melanoma skin cancer or malignancies treated with curative intent and no evidence of active disease for ≥3 years;
- Cardiovascular conditions:
- NYHA Class III or IV heart failure;
- Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to screening;
- Clinically significant ventricular arrhythmias or unexplained syncope (excluding vasovagal or dehydration);
- Severe non-ischemic cardiomyopathy;
- Active or uncontrolled autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;
- Positive for HBsAg or HBcAb with elevated HBV DNA in peripheral blood; positive for HCV antibodies with detectable HCV RNA levels; positive for HIV antibodies; positive syphilis test;
- Toxicity from prior anti-tumor treatments has not resolved to baseline or ≤grade 1, except for alopecia or peripheral neuropathy;
- History of venous thromboembolism (e.g., pulmonary embolism) requiring ongoing anticoagulation treatment, or meeting one of the following criteria:
- Severe bleeding (grade 3 or 4) lasting for ≥30 days;
- Post-thrombotic sequelae (e.g., persistent dyspnea and hypoxia) due to venous thromboembolism;
- Pregnant or breastfeeding women;
- Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the trial.
Key Trial Info
Start Date :
September 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07181720
Start Date
September 12 2025
End Date
May 31 2028
Last Update
October 2 2025
Active Locations (1)
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1
The 901 Hospital of Joint Logistics Support Force of People Liberation Army
Hefei, Anhui, China, 230031