A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Gynecologic Cancer

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

This is a single-center, double-arm, open-label study. this study plans to evaluate the safety and efficacy of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced/metastatic Gynecologic Cancer, and obtain recommended doses and infusion patterns.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Age ≥18 years old;

⁃ Advanced/metastatic gynecological tumor confirmed by histopathology or cytology (paraffin sections or fresh biopsy tumor tissue specimens) (CD70 positive tumor expression (CD70 positive tumor confirmed by histology or pathology (IHC 3+));

⁃ Failure or intolerance after standard treatment (disease progression or intolerance such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.), and currently no effective treatment;

⁃ According to the RECIST version 1.1 standard, there is at least one measurable diameter and evaluable target lesion. Measurable lesions are defined as: extranodal lesions with CT scan diameter ≥10mm, lymph node lesions with CT scan diameter ≥15mm, scan layer thickness ≤ 5mm, and have not received local treatment;

⁃ ECOG 0 \

• 2 points ;

⁃ Expected survival time is more than 12 weeks;

⁃ No serious mental disorders;

⁃ The functions of important organs are basically normal:

• Hematopoietic function: neutral granules \>1.0×109/L, platelet \>75×109/L, hemoglobin \>80g/L;

∙ Cardiac function: Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;

∙ Renal function: serum creatinine ≤2.0×ULN;

∙ Liver function: ALT and AST ≤2.0×ULN (patients with liver tumor infiltration can be relaxed to ≤3.0×ULN);

∙ Total bilirubin ≤2.0×ULN (Gilbert syndrome or liver tumor infiltration can be relaxed to ≤3.0×ULN);

∙ Blood oxygen saturation in non-oxygen state\>92%.

⁃ Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;

‣ The subject agrees to use a reliable and effective contraceptive method for contraception (excluding safe period contraception) within 1 year from signing the informed consent to receiving the CAR T cell infusion;

‣ The subject or his/her guardian agrees to participate in the clinical trial and signs the ICF, indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study.

Locations
Other Locations
China
The First Affiliated Hospital of Wannan Medical College
RECRUITING
Wuhu
Contact Information
Primary
Guantai Ni, M.D
niguantai@yjsyy.com
13705535528
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 36
Treatments
Experimental: Intravenous of CD70-targeted CAR-T
Infusion of CD70-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg
Experimental: intraperitoneal injection of CD70-targeted CAR-T
Infusion of CD70-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg
Related Therapeutic Areas
Sponsors
Leads: Chongqing Precision Biotech Co., Ltd

This content was sourced from clinicaltrials.gov