4SCAR-CD44v6 T Cell Therapy Targeting Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    100
  • sponsor
    Shenzhen Geno-Immune Medical Institute
Updated on 25 January 2021

Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of 4SCAR-CD44v6 T-cell therapy targeting multiple cancers. The study also aims to learn more about the function of the CD44v6 CAR-T cells and their persistency in the patients.

Description

CD44 variant domain 6 (CD44v6) which belongs to CD44 family has been implicated in tumorigenesis, tumor cell invasion and metastasis. The expression of CD44v6 was reported for the majority of squamous cell carcinomas, a proportion of adenocarcinomas of differing origin, a proportion of melanoma and lymphoma. This expression pattern has made CD44v6 an attractive target for the therapy of various types of CD44v6 positive cancers.

The T cells from patients or transplantation donors will be genetically modified with lentiviral CAR vector to recognize specific molecules - CD44v6 expressed on the surface of the cancer cells. The engineered T cells will be applied to patients through intravenous delivery.

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CD44v6 CAR-T cell therapy in multiple cancers including - but not limited to - stomach cancer, breast cancer, prostate cancer, multiple myeloma and lymphoma which are CD44v6 positive. Another goal of the study is to learn more about the function of the 4SCAR-CD44v6 T cells and their persistency in the patients.

Details
Condition Cancers Which Are CD44v6 Positive
Treatment CD44v6-specific CAR gene-engineered T cells
Clinical Study IdentifierNCT04427449
SponsorShenzhen Geno-Immune Medical Institute
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age older than 6 months
Confirmed expression of CD44v6 in tumor specimens by immuno-histochemical staining or flow cytometry
Karnofsky performance status (KPS) score is higher than 70 and life expectancy > 3 months
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction 50%, oxygen saturation 90%, creatinine 2.5 upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 upper limit of normal, total bilirubin 2.0mg/dL
Hgb80g/L
No cell separation contraindications
Abilities to understand and the willingness to provide written informed consent

Exclusion Criteria

Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection
Active bacterial, fungal or viral infection not controlled by adequate treatment
Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Pregnant or nursing women may not participate
Use of glucocorticoid for systemic therapy within one week prior to entering the trial
Receive treatment related to CD44v6 targeted therapy
Patients, in the opinion of investigators, may not be able to comply with the study
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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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