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Trial record 1 of 1 for:    NCT04427449
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4SCAR-CD44v6 T Cell Therapy Targeting Cancer

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ClinicalTrials.gov Identifier: NCT04427449
Recruitment Status : Unknown
Verified June 2020 by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute.
Recruitment status was:  Recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Shenzhen Hospital of Southern Medical University
The Seventh Affiliated Hospital of Sun Yat-sen University
Shenzhen Children's Hospital
Information provided by (Responsible Party):
Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cancers Which Are CD44v6 Positive Biological: CD44v6-specific CAR gene-engineered T cells Phase 1 Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center Phase I/II Clinical Trial of 4SCAR-CD44v6 T Cells for Treating Cancer
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Single arm 4SCAR-CD44v6 T cells to treat cancer Biological: CD44v6-specific CAR gene-engineered T cells
4SCAR-CD44v6 Infusion of 4SCAR-CD44v6 T cells at 10^6 cells/kg body weight


Outcome Measures
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Primary Outcome Measures :
  1. Safety of infusion [ Time Frame: 1 year ]
    Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.

  2. Clinical response [ Time Frame: 1 year ]
    Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age older than 6 months.
  2. Confirmed expression of CD44v6 in tumor specimens by immuno-histochemical staining or flow cytometry.
  3. Karnofsky performance status (KPS) score is higher than 70 and life expectancy > 3 months.
  4. 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.
  5. Hgb≥80g/L.
  6. No cell separation contraindications.
  7. Abilities to understand and the willingness to provide written informed consent.

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427449


Locations
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China, Guangdong
Shenzhen Children's Hospital Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Sixi Liu, MD    86-189 3869 0206    tiger647@126.com   
Contact: Xiuli Yuan, MD    86-18938690212    18938690212@163.com   
Shenzhen Geno-immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-075586725195    c@szgimi.org   
Shenzhen Hospital of Southern Medical University Recruiting
Shenzhen, Guangdong, China, 518101
Contact: Jie Mao, MD    86-0755-233    myw921@163.com   
The Seventh Affilliated Hospital, Sun Yat-Sen University Recruiting
Shenzhen, Guangdong, China, 518107
Contact: Bo Wang, MD    86-0755-23242570    wangb68377@sina.com   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
Shenzhen Hospital of Southern Medical University
The Seventh Affiliated Hospital of Sun Yat-sen University
Shenzhen Children's Hospital
More Information
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Responsible Party: Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT04427449    
Other Study ID Numbers: GIMI-IRB-20004
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute:
CAR-T
CD44v6
Breast cancer
Gastric cancer
Lymphoma