CLDN6-CAR-NK Cell Therapy for Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    May 31, 2034
  • participants needed
    40
  • sponsor
    Second Affiliated Hospital of Guangzhou Medical University
Updated on 17 June 2022

Summary

This study is a single-arm, open, exploratory clinical study to evaluate the safety and preliminary efficacy of Claudin6 targeting CAR-NK cells in patients with Claudin6-positive advanced solid tumors (ovarian cancer and others)

Description

  1. Choose appropriate advanced cancer patients with Claudin6 expression, with written consent for the study;
  2. Perform PBMCs apheresis from the patient and isolate NK cells, transfect the NK cells with Claudin6 targeting CAR, amplify the number of transfected NK cells as needed, test the quality and killing activity of the Claudin6-CAR-NK cells and then transplant back the patients via systemic or local infusions (via artery or intra-tumor), and follow up closely to collect related results as needed;
  3. To enhance the killing capability, some CAR-NK cells are genetically engineered to express and secret IL7/CCL19 and/or SCFVs against PD1/CTLA4/Lag3;
  4. Evaluate the clinical results as needed.
  5. Will also perform the similar clinical trial on different cancer types with Claudin6 expression.

Details
Condition Stage IV Ovarian Cancer, Testis Cancer, Refractory, Endometrial Cancer Recurrent, CAR NK
Treatment Claudin6 targeting CAR-NK cells
Clinical Study IdentifierNCT05410717
SponsorSecond Affiliated Hospital of Guangzhou Medical University
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

patients with advanced ovarian cancer or other cancers with expression of claudin6
Life expectancy >12 weeks
Adequate heart,lung,liver,kidney function
Available autologous transduced NK cells with greater than or equal to 20% expression of claudin6-CAR determined by flow-cytometry and killing of claudin6-positive targets greater than or equal to 20% in cytotoxicity assay
Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. -

Exclusion Criteria

Had accepted gene therapy before
Tumor size more than 25cm
Severe virus infection such as HBV,HCV,HIV,et al
Known HIV positivity
History of liver/renal transplantation
Active infectious disease related to bacteria, virus,fungi,et al
Other severe diseases that the investigators consider not appropriate
Pregnant or lactating women
Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
Other conditions that the investigators consider not appropriate. -
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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