Clinical trial for Metastatic Tumor
Official title A Clinical Study of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05518253
What this study is testing
What is CD70 CAR-T cells?
CD70 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years old, male or female;
- Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced/metastatic solid tumor (positive tumor CD70...
- Failure or intolerance after standard treatment (disease progression or intolerance such as surgery, chemotherapy, radiotherapy, targeted therapy...
- According to the RECIST version 1.1 standard, at least one target lesion with measurable diameter and evaluable, measurable lesions are defined as...
- ECOG 0-2 points;
You likely can't join if
- Received anti-CD70 drug treatment before screening;
- Active/symptomatic central nervous system metastases or meningeal metastases at the time of screening; people with brain metastases who have been...
- Received any of the following treatments prior to screening:
- Participated in other treatment clinical studies before screening, including: the last use of unmarketed new drugs is less than 3 months before cell...
- Received anti-tumor therapy such as chemotherapy and targeted therapy within 2 weeks or at least 5 half-lives (whichever is shorter) before apheresis;
- Received systemic corticosteroid therapy at doses greater than 10 mg/day prednisone (or equivalent doses of other corticosteroids) within 2 weeks...
See the full eligibility criteria
Who can join
- Age ≥18 years old, male or female;
- 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...
- 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;
- 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...
- ECOG 0-2 points;
- The expected survival time is more than 12 weeks;
- No serious mental disorder;
- The function of important organs is basically normal:
- Hematopoietic function: neutrophils\>1.0×109/L, platelets\>75×109/L, hemoglobin\>80g/L;
- Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;
- Renal function: serum creatinine≤2.0×ULN;
- Liver function: ALT and AST ≤2.0×ULN (for patients with liver tumor infiltration, it can be relaxed to ≤3.0×ULN);
- Total bilirubin ≤2.0×ULN (Gilbert syndrome or combined liver tumor infiltration can be relaxed to ≤3.0×ULN);
- Oxygen saturation \> 92% in non-oxygen state.
- Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;
- people 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;
- people 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.
What rules you out
- Received anti-CD70 drug treatment before screening;
- Active/symptomatic central nervous system metastases or meningeal metastases at the time of screening; people with brain metastases who have been treated must be confirmed to have no imaging-proven progression ≥4 weeks...
- Received any of the following treatments prior to screening:
- Participated in other treatment 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...
- Received anti-tumor therapy such as chemotherapy and targeted therapy within 2 weeks or at least 5 half-lives (whichever is shorter) before apheresis;
- 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...
- Received live attenuated vaccine within 4 weeks before screening;
- Active infection or uncontrollable infection requiring systemic treatment within 1 week before screening;
- 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...
- Have any of the following heart conditions:
- New York Heart Association (NYHA) stage III or IV congestive heart failure;
- Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;
- Clinically significant ventricular arrhythmia, or a history of unexplained syncope (except those caused by vasovagal or dehydration);
- History of severe nonischemic cardiomyopathy.
- Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;
- 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...
- 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...
- 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...
- Women who are pregnant or breastfeeding, and male or female people who plan to have children within 1 year after receiving CAR-T cell reinfusion;
- Other investigators deem it inappropriate to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.