Study of Anti-5T4 CAR-NK Cell Therapy in Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    40
  • sponsor
    Wuxi People's Hospital
Updated on 24 March 2022

Summary

This study is an interventional, single arm, open-label, investigator-initiated trial (IIT) to evaluate the safety, tolerability, initial efficacy and pharmacokinetics (PK) of anti-5T4 CAR-NK cells in patients with advanced solid tumors.

Description

The treatment cycle in this study is 21 days. The administration of CAR-NK cell will be performed on day 1 and day 3 of each cycle. Subjects will be treated continuously until the criteria for termination of treatment are met. In this study, the dose escalation design is adopted. The first administration dose in the first cycle is 3.0×10^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 4.0×10^9 cells, and each administration dose in the second cycle and thereafter would be 4.0×10^9 cells.

Details
Condition Advanced Solid Tumors
Treatment Anti-CAR-NK Cells
Clinical Study IdentifierNCT05194709
SponsorWuxi People's Hospital
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures
Age: adult at the age of 18-80 (both inclusive), female or male
Patients with advanced malignant solid tumors, histologically or cytologically confirmed, who had failed standard therapy, or had no standard therapy, or were not eligible for standard therapy at this stage; tumor biomarkers combined with imaging can be used to diagnose some special advanced tumors
Eastern Cooperative Oncology Group (ECOG) score ≤2 and expected survival time >3 months
Organ function during screening should meet the following criteria
Absolute neutrophil count (ANC)≥0.8×109/L
Platelet (PLT)≥50×109/L
Hemoglobin (Hb)≥80g/L
Total bilirubin (TBIL)≤2×ULN
Alanine aminotransferase (ALT)≤3×ULN; Patients with liver metastasis or liver cancer: ≤5×ULN
Aspartate aminotransferase (AST)≤3×ULN; Patients with liver metastasis or liver cancer: ≤5×ULN
Creatinine (Cr)≤1.5× ULN
Creatinine clearance (Ccr) (to be calculated only when Cr > 1.5× ULN)>50ml/min/1.73m2 (Cockcroft-Gault formula)
Activated partial thrombin time (APTT)≤1.5×ULN
International normalized ratio (INR)≤1.5×ULN
Subjects of reproductive age and their partners should agree to have no family
planning and to use effective contraceptive methods (hormonal or barrier
methods or abstinence, etc.) for 6 months from signing the ICF until the last
dose of the study drug is administered; women of reproductive age should not
be pregnant or breastfeeding

Exclusion Criteria

Have received systemic antitumor therapy, including chemotherapy, immunotherapy, and radical radiotherapy, within 1 week prior to their first use of the study drug
Have participated in other clinical trials and received any unmarketed investigational drug or treatment within 4 weeks prior to first use of the study drug
Any prior adoptive cellular immunotherapy
Have undergone major organ surgery (excluding needle biopsy or surgery related to this indication) within 4 weeks prior to their first use of the study drug, or required elective surgery during the study period
Patients with severe infections that cannot be controlled
Patients with a known history of human immunodeficiency virus (HIV) infection, or a history of organ transplantation
Have active autoimmune diseases or have had autoimmune diseases that are likely to recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.). Except in the following cases: type 1 diabetes that was well controlled with hormone replacement therapy, hypothyroidism, skin conditions that did not require systemic therapy (e.g., vitiligo), and other conditions that were well controlled and that the investigator determined were less likely to recur (e.g., childhood asthma in remission)
Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to
There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia, and Ⅱ-Ⅲ degree atrioventricular block, which need clinical intervention
The mean QT interval corrected by Fridericia method (QTcF) is prolonged (male>450ms, female>470ms)
Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurring within 6 months before the first administration
Patients with heart failure or left ventricular ejection fraction (LVEF) < 50% in the New York Heart Association (NYHA) classification ≥II
Hypertension beyond clinical control
Adverse effects of previous antineoplastic therapy have not returned to CTCAE grade
0≤2 (except for toxicity that the investigator determined to be of no safety
risk, such as alopecia, hypothyroidism stabilized by hormone replacement
therapy)
Central nervous system metastases with clinical symptoms
Had other malignant tumors in the past 3 years, excluding skin basal cell carcinoma, ductal carcinoma in situ and cervical carcinoma in situ with a radical surgery
Have a history of alcohol or drug abuse or mental disorder
The investigator considered that the subjects had a history of other serious systemic diseases or other reasons that made them unsuitable for the study
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