4SCAR-CD44v6 T Cell Therapy Targeting Cancer

Cancers Which Are CD44v6 Positive Clinical Trial

Official title:

Multi-center Phase I/II Clinical Trial of 4SCAR-CD44v6 T Cells for Treating Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04427449
• Other study ID #: GIMI-IRB-20004
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2020
• Source: Shenzhen Geno-Immune Medical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancers Which Are CD44v6 Positive

Intervention

Biological:
• CD44v6-specific CAR gene-engineered T cells
4SCAR-CD44v6 Infusion of 4SCAR-CD44v6 T cells at 10^6 cells/kg body weight

Locations

Country	Name	City	State
China	Shenzhen Children's Hospital	Shenzhen	Guangdong
China	Shenzhen Geno-immune Medical Institute	Shenzhen	Guangdong
China	Shenzhen Hospital of Southern Medical University	Shenzhen	Guangdong
China	The Seventh Affilliated Hospital, Sun Yat-Sen University	Shenzhen	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Shenzhen Geno-Immune Medical Institute	Shenzhen Children's Hospital, Shenzhen Hospital of Southern Medical University, The Seventh Affilliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of infusion	Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.	1 year
Primary	Clinical response	Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.	1 year