Universal 4SCAR7U Targeting CD7-positive Malignancies

Recruiting now · Phase 1

Conditions studied: T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, Acute Myeloid Leukemia, NK Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT05995028

Run by

Shenzhen Geno-Immune Medical Institute

People needed

30

Starts

2023-10-31

Expected to finish

2026-12-31

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 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.
• 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 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.
• Previous treatment with any gene therapy products.
• 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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