4SCAR-CD44v6 T Cell Therapy Targeting Cancer
ConditionCancers Which Are CD44v6 Positive
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-75
SponsorShenzhen Geno-Immune Medical Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
CD44v6-specific CAR gene-engineered T cells
Biological/Vaccine4SCAR-CD44v6 Infusion of 4SCAR-CD44v6 T cells at 10\^6 cells/kg body weight
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Experimental: Single arm 4SCAR-CD44v6 T cells to treat cancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of infusion
Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
Time frame
1 year2
Clinical response
Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov