Universal 4SCAR7U Targeting CD7-positive Malignancies

Trial statusRecruiting
Trial phasePhase 1
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 universal CAR T cells based on 4SCAR7U design against CD7-positive hematological malignancies using CD7 specific universal CAR T cells. The study also aims to learn more about the function of CD7 targeting CAR T cells and their persistence in patients of hematological malignancies.

Eligibility criteria

Qualifiers

Age older than 6 months.

Confirmed expression of CD7 and additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry.

Karnofsky performance status (KPS) score is higher than 80 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 or hepatitis C virus (HCV) infection.

Pregnant or nursing women may not participate.

Trial design

Treatments tested in this trial

  • Universal CD7-specific CAR gene-engineered T cells

Treatment groups

30 Participants
are divided into 1 treatment group