Status:
UNKNOWN
4SCAR-CD44v6 T Cell Therapy Targeting Cancer
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Collaborating Sponsors:
Shenzhen Hospital of Southern Medical University
The Seventh Affiliated Hospital of Sun Yat-sen University
Conditions:
Cancers Which Are CD44v6 Positive
Eligibility:
All Genders
6-75 years
Phase:
PHASE1
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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.
- Hgb≥80g/L.
- No cell separation contraindications.
- Abilities to understand and the willingness to provide written informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04427449
Start Date
June 1 2020
End Date
December 31 2023
Last Update
June 11 2020
Active Locations (4)
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1
Shenzhen Children's Hospital
Shenzhen, Guangdong, China, 518000
2
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
3
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China, 518101
4
The Seventh Affilliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, China, 518107