CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors
Clinical Study of CD70-Targeted Chimeric Antigen Receptor T Lymphocytes (CAR-T) in Advanced CD70-Positive Malignant Solid Tumors
1 other identifier
interventional
90
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2025
CompletedStudy Start
First participant enrolled
September 12, 2025
CompletedFirst Posted
Study publicly available on registry
September 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
October 2, 2025
September 1, 2025
2.6 years
September 12, 2025
September 28, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
To evaluate the safety of CAR-T cell preparations in the treatment of CD70-positive advanced malignancies [Safety and Tolerability]
Incidence of adverse events during the study, evaluated per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) criteria
1 month
Obtained the recommended dose and infusion regimen of CAR-T cells for the treatment of patients with CD70-positive advanced malignancies [Safety and Tolerability]
Dose-limiting toxicity after CD70 CAR-T cell infusion
1 month
Secondary Outcomes (4)
Assessing disease control rates of CAR-T cell preparations in CD70-positive advanced malignancies [Effectiveness]
1 and 3 months
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
From infusion through Month 3
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
From infusion through Month 3
To assess the inflammatory response following CAR-T cell infusion
From infusion through Month 3
Other Outcomes (4)
Objective response rate (ORR) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies [Effectiveness]
2 years
Duration of Response (DOR) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies [Effectiveness]
2 years
Progress-free survival(PFS) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies [Effectiveness]
2 years
- +1 more other outcomes
Study Arms (3)
Intravenous of CD70-targeted CAR-T
EXPERIMENTALInfusion of CD70-targeted CAR-T cells by dose of 3-10x10\^5 cells/kg
Intrapleural infusion of CD70-targeted CAR-T
EXPERIMENTALInfusion of CD70-targeted CAR-T cells by dose of 3-10x10\^5 cells/kg
Intraperitoneal infusion of CD70-targeted CAR-T
EXPERIMENTALInfusion of CD70-targeted CAR-T cells by dose of 3-10x10\^5 cells/kg
Interventions
Administration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
Eligibility Criteria
You may qualify if:
- 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);
- +4 more criteria
You may not qualify if:
- 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.;
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The 901 Hospital of Joint Logistics Support Force of People Liberation Army
Hefei, Anhui, 230031, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donglai Lv, MD
The 901 Hospital of Joint Logistics Support Force of People Liberation Army
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2025
First Posted
September 18, 2025
Study Start
September 12, 2025
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share