To Evaluate the Safety and Tolerability of Anti-Human CD70 T-Cell Injection in Subjects With Advanced/Metastatic Renal Cancer

NCT07647744 | Not Yet Recruiting Phase 1

• 1 other identifier: HRAIN01-RCC01-Ⅰ
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, dose-escalating Phase 1 clinical study. It aims to evaluate the safety, tolerability and pharmacokinetic(PK) profiles of the investigational agent, and preliminarily assess its efficacy in subjects with advanced/metastatic renal cell carcinoma, and determine the recommended dose and infusion regimen for Phase 2 trials.

Conditions

Renal Cell Carcinoma (RCC)

Keywords

Renal cell carcinoma; Chimeric antigen receptor; CD70

Outcome Measures

Primary Outcomes (1)

• Dose limited toxicity (DLT)

  28 days post infusion

Secondary Outcomes (12)

• Number of subjects with adverse event

  2 years post infusion

• Change from baseline in perform status as measured by Eastern Cooperative Oncology Group (ECOG) performance status score

  2 years post infusion

• Number of participants with clinically significant changes from baseline in laboratory parameters

  2 years post infusion

• Number of participants with clinically significant changes from baseline in physical examination findings

  2 years post infusion

• Pharmacokinetics parameters - Maximum concentration (Cmax)

  2 years post infusion

Study Arms (1)

Anti-Human CD70 T-Cell Injection

EXPERIMENTAL

Drug: Anti-Human CD70 T-Cell Injection

Interventions

Anti-Human CD70 T-Cell Injection DRUG

Autologous genetically modified anti-Human CD70 CAR transduced T cells

Anti-Human CD70 T-Cell Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 70 years (inclusive), regardless of gender;
• Life expectancy of more than 12 weeks;
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1;
• Subjects with advanced/metastatic renal cell carcinoma (RCC):
• Histologically confirmed clear cell renal cell carcinoma (ccRCC), with an International Metastatic RCC Database Consortium (IMDC) risk stratification of intermediate or high risk as evaluated by the investigator;
• Has at least one measurable lesion according to RECIST 1.1;
• Tumor tissue samples must test positive for CD70 expression via immunohistochemistry (IHC);
• Must have received at least one prior line of systemic therapy (must include at least: (1) immuno-oncology (IO) combination therapy: concomitant targeting of PD-1 and CTLA-4, or (2) an immune checkpoint inhibitor (PD-1/PD-L1 inhibitor) combined with a VEGF/VEGFR-targeted agent);
• Venous access required for apheresis can be established; hemoglobin ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5×10\^9/L, and platelet count ≥ 100× 10\^9/L, and the leukepheresis can be carried according to the judgement of investigators;
• Hepatic, renal, cardiac, and pulmonary functions must meet the following criteria:
• Creatinine clearance (CrCl) ≥ 50 mL/min (calculated by the Cockcroft-Gault formula);
• Left ventricular ejection fraction (LVEF) \> 50%;
• Baseline peripheral oxygen saturation \> 95%;
• Total bilirubin ≤2 × upper limit of normal (ULN);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN;

You may not qualify if:

• Prior treatment with anti-CD70 targeted therapies;
• Brain metastasis from renal cell carcinoma;
• Concomitant with other uncontrolled malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after radical surgery;
• Any uncontrolled active infection, including but not limited to active tuberculosis; presence or suspicion of an uncontrolled infection, or an infection requiring systemic intravenous therapy within 14 days prior to enrollment (including fungal, bacterial, viral, or other infections);
• Subjects who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, with peripheral blood HBV DNA titers above the lower limit of detection (LLOD) of the study site; those who are hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA positive; those who are human immunodeficiency virus (HIV) antibody positive; or those who test positive for syphilis;
• Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack within 6 months prior to screening, myocardial infarction within 6 months prior to screening, congestive heart failure (New York Heart Association \[NYHA\] classification ≥ III ), poorly controlled diabetes mellitus (glycated hemoglobin HbA1c \> 8% at screening), poorly controlled severe arrhythmia, and hepatic, renal, or metabolic diseases by medication;
• Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion (except for subjects of childbearing potential who are willing to use highly effective and reliable methods of contraception uninterruptedly for 1 year after the study treatment);
• Prior treatment with CAR-T therapy or other genetically modified cell therapies prior to screening;
• History of implantation of a cardiac pacemaker or deep brain stimulator;
• Vaccination with live attenuated vaccines within 4 weeks prior to leukapheresis;
• History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that resulted in end-organ damage, or required systemic immunosuppressive therapy or other systemic disease-controlling medications;
• History of central nervous system (CNS) diseases, such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or psychiatric disorders; or known active CNS involvement or history thereof;
• Subjects who are receiving systemic steroid therapy prior to screening, and who are judged by the investigator to require long-term use of systemic steroids during the study treatment period (excluding inhaled or topical steroids);
• Presence of medical conditions that interfere with the ability to sign the written Informed Consent Form (ICF) or comply with study procedures; or those who are unwilling or unable to comply with study requirements;
• History of severe immediate hypersensitivity reactions to any of the medications to be used in this study;

Sponsors & Collaborators

• Hrain Biotechnology Co., Ltd.: lead
• RenJi Hospital: collaborator

Study Sites (1)

RenJi Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200000, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Fang Xiang

CONTACT

86-21-58552006; xiangfang@dashengbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2034
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)