An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD70-CAR-T Cell Injection in Patients With Locally Advanced or Relapsed/Metastatic Renal Cell Carcinoma With CD70+ Inoperable

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This is an investigator-initiated trial to evaluate the role of anti-CD70-CAR T cells in locally advanced or recurrent/metastatic renal cell carcinoma that is inoperable.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Understand and sign informed consent, and voluntarily participate in clinical research;

• Age ≥18, and \<70 years old, gender is not limited;

• Histopathologically or cytologically confirmed advanced malignant renal cell carcinoma of CD70+ with at least VEGFR-targeted therapy and an immune checkpoint therapy (either combination therapy or sequential therapy);

• At least one measurable lesion with a maximum diameter of less than 6 cm according to RECIST 1.1;

• Expected survival ≥12 weeks;

• ECOG score ≤2 points;

• Have sufficient hematologic function and have not received blood transfusion or cell growth factor therapy within 7 days prior to the hematologic evaluation during the screening period (2 weeks interval is required for those receiving long-acting agents such as PEG-rhG-CSF, allowing the use of recombinant erythropoietin) :

‣ Neutrophil absolute value ≥1.5×109/L

⁃ Hemoglobin ≥80g/L

⁃ Platelets ≥75×109/L

⁃ Lymphocytes (ALC) ≥0.3×109/L

• Adequate liver function: serum total bilirubin ≤1.5× upper limit of normal (ULN) (for Gilbert syndrome patients, total bilirubin ≤3×ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN; If there is liver metastasis, allow AST, ALT≤5×ULN);

• Adequate renal function: creatinine ≤1.5×ULN or endogenous creatinine clearance ≥50 mL/min (using Cockcroft Gault formula);

⁃ Left ventricular ejection fraction (LVEF) of echocardiography was ≥50%.

⁃ There was no evidence of dyspnea at rest and pulse oximetry was \>93% without oxygen.

⁃ Activated partial thromboplastin time (APTT) ≤1.5×ULN and International normalized ratio (INR) ≤1.5×ULN;

⁃ Good venous access (for apheresis) and no other contraindications for blood cell separation;

⁃ Pregnancy tests for women of childbearing age must be negative. All subjects must agree to use an effective contraceptive method at the same time from the time of signing the informed consent to 12 months after the final administration of the study drug.

Locations
Other Locations
China
Changzheng hospital
RECRUITING
Shanghai
Contact Information
Primary
Shancheng Ren, MD,PhD
renshancheng@gmail.com
139 1779 3885
Backup
Zhixiang Xin, MD
xiaoxin973@hotmail.com
13636391268
Time Frame
Start Date: 2024-09-06
Estimated Completion Date: 2027-07-16
Participants
Target number of participants: 9
Treatments
Experimental: Assigned Interventions
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai First Song Biotechnology Co., LTD
Leads: Shanghai Changzheng Hospital

This content was sourced from clinicaltrials.gov