4SCAR-CD44v6 T Cell Therapy Targeting Cancer
Recruiting now · Phase 1/Phase 2
Conditions studied: Cancers Which Are CD44v6 Positive
In brief
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.
Key facts
- Study ID
- NCT04427449
- Run by
- Shenzhen Geno-Immune Medical Institute
- People needed
- 100
- Starts
- 2026-06-01
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2026-06-23
Who can join
Age: 1 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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