4SCAR-CD44v6 T Cell Therapy Targeting Cancer

Launched by SHENZHEN GENO-IMMUNE MEDICAL INSTITUTE · Jun 9, 2020

Keywords

ClinConnect Summary

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 th...

Gender

ALL

Eligibility 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.