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Trial Title:
A Clinical Study of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
NCT ID:
NCT05518253
Condition:
Metastatic Tumor
Advanced Solid Tumor
Renal Cell Carcinoma
Ovarian Cancer
Cervix Cancer
Conditions: Official terms:
Neoplasms
Carcinoma, Renal Cell
Uterine Cervical Neoplasms
Neoplasm Metastasis
Conditions: Keywords:
CAR-T
CD70
CD70-positive advanced/metastatic solid tumors
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CD70 CAR-T cells
Description:
Administration method: intravenous infusion; Subjects will be treated with Fludarabine
and Cyclophosphamide before cell infusion.
Arm group label:
Intravenous of CD70-targeted CAR-T
Intervention type:
Biological
Intervention name:
CD70 CAR-T cells
Description:
Administration method: intraperitoneal injection; Subjects will be treated with
Fludarabine and Cyclophosphamide before cell infusion.
Arm group label:
intraperitoneal injection of CD70-targeted CAR-T
Summary:
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in
patients with CD70-positive advanced/metastatic solid tumors, and to obtain the maximum
tolerated dose of CAR-T and phase II Recommended dose.
Detailed description:
This is a single-center, double-arm, open-label study. The study plans to set up 2
groups,Intravenous infusion group have 4 dose groups, adopting a dose-escalating 3+3
design, and plan to recruit about 12 subjects with CD70-positive advanced/metastatic
solid tumors.Intraperitoneal injection group have 4 dose groups, adopting a
dose-escalating 3+3 design, and plan to recruit about 12 subjects with CD70-positive
advanced/metastatic solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years old, male or female;
2. Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen)
diagnosed as advanced/metastatic solid tumor (positive tumor CD70 expression (tumor
CD70 positive (IHC 3+) confirmed by histology or pathology));
3. Failure or intolerance after standard treatment (disease progression or intolerance
such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.), and there is
currently no effective treatment;
4. According to the RECIST version 1.1 standard, at least one target lesion with
measurable diameter and evaluable, measurable lesions are defined as: extranodal CT
scan long diameter ≥ 10mm, lymph node lesions CT scan short diameter ≥ 15mm, scan
slice thickness Not larger than 5mm, and has not received local treatment;
5. ECOG 0-2 points;
6. The expected survival time is more than 12 weeks;
7. No serious mental disorder;
8. The function of important organs is basically normal:
1. Hematopoietic function: neutrophils>1.0×109/L, platelets>75×109/L,
hemoglobin>80g/L;
2. Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and
no obvious abnormality was found on electrocardiogram;
3. Renal function: serum creatinine≤2.0×ULN;
4. Liver function: ALT and AST ≤2.0×ULN (for patients with liver tumor
infiltration, it can be relaxed to ≤3.0×ULN);
5. Total bilirubin ≤2.0×ULN (Gilbert syndrome or combined liver tumor infiltration
can be relaxed to ≤3.0×ULN);
6. Oxygen saturation > 92% in non-oxygen state.
9. Have apheresis or venous blood collection standards, and have no other
contraindications for cell collection;
10. Subjects agree to use reliable and effective contraceptive methods for contraception
(excluding safe period contraception) within 1 year after signing the informed
consent form to receiving CAR-T cell infusion;
11. Subjects or their guardians agree to participate in this clinical trial and sign the
ICF, indicating that they understand the purpose and procedures of this clinical
trial and are willing to participate in the research.
Exclusion Criteria:
1. Received anti-CD70 drug treatment before screening;
2. Active/symptomatic central nervous system metastases or meningeal metastases at the
time of screening; subjects with brain metastases who have been treated must be
confirmed to have no imaging-proven progression ≥4 weeks after the end of treatment
before they can be enrolled;
3. Received any of the following treatments prior to screening:
1. Participated in other interventional clinical studies before screening,
including: the last use of unmarketed new drugs is less than 3 months before
cell reinfusion, or the last use of marketed drugs is less than 5 half-lives
from cell reinfusion;
2. Received anti-tumor therapy such as chemotherapy and targeted therapy within 2
weeks or at least 5 half-lives (whichever is shorter) before apheresis;
3. Received systemic corticosteroid therapy at doses greater than 10 mg/day
prednisone (or equivalent doses of other corticosteroids) within 2 weeks prior
to apheresis (inhalation or topical is allowed in the absence of active
autoimmune disease Use steroids and adrenal corticosteroid replacement at doses
greater than 10 mg/day of prednisone);
4. Received live attenuated vaccine within 4 weeks before screening;
4. Active infection or uncontrollable infection requiring systemic treatment within 1
week before screening;
5. Malignant tumors other than the target tumor within 3 years prior to screening,
except for the following: malignant tumors that have received radical treatment and
no known active disease within ≥ 3 years prior to enrollment; or adequately treated
of non-melanoma skin cancers with no evidence of disease;
6. Have any of the following heart conditions:
1. New York Heart Association (NYHA) stage III or IV congestive heart failure;
2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months
before enrollment;
3. Clinically significant ventricular arrhythmia, or a history of unexplained
syncope (except those caused by vasovagal or dehydration);
4. History of severe nonischemic cardiomyopathy.
7. Known to have active or uncontrolled autoimmune diseases, such as Crohns disease,
rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;
8. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive
and peripheral blood hepatitis B virus (HBV) DNA titer is greater than the normal
range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C
Virus (HCV) RNA titer test is greater than the normal range; human immunodeficiency
virus (HIV) antibody positive; syphilis test positive; cytomegalovirus (CMV) DNA
test positive;
9. The subject has experienced venous thromboembolic events (eg: pulmonary embolism)
and still needs anticoagulation therapy, or meets the following conditions: a.
Bleeding with grades 3 to 4 for more than 30 days; b. venous thrombosis Sequelae
(such as persistent dyspnea and hypoxia); (Note: although subjects with venous
thrombosis but not meeting the above conditions can participate in the trial);
10. Poorly controlled hypertension, defined as systolic blood pressure ≥ 150 mmHg and/or
diastolic blood pressure ≥ 90 mmHg (blood pressure values measured based on the
average of 3 readings at least 2 minutes apart, blood pressure ≥ 150/90 mmHg at
initial screening is acceptable Antihypertensive treatment, screening can be
performed if the blood pressure is less than 150/90mmHg and well controlled after
treatment);
11. Women who are pregnant or breastfeeding, and male or female subjects who plan to
have children within 1 year after receiving CAR-T cell reinfusion;
12. Other investigators deem it inappropriate to participate in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
First affiliated hospital, Zhejiang University
Address:
City:
Hangzhou
Zip:
310006
Country:
China
Status:
Recruiting
Contact:
Last name:
Weijia fang, MD
Phone:
13758211655
Email:
weijia.fang@163.com
Investigator:
Last name:
Weijia fang, MD
Email:
Principal Investigator
Start date:
May 30, 2022
Completion date:
May 30, 2025
Lead sponsor:
Agency:
Weijia Fang, MD
Agency class:
Other
Collaborator:
Agency:
Chongqing Precision Biotech Co., Ltd
Agency class:
Industry
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05518253