Universal 4SCAR7U Targeting CD7-positive Malignancies

Launched by SHENZHEN GENO-IMMUNE MEDICAL INSTITUTE · Aug 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment called universal CAR T cells, specifically designed to target a protein known as CD7 found on certain types of blood cancers, including T-cell Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia. The main goals of the trial are to see if this treatment is safe and effective, and to learn how well these CAR T cells work in patients with these types of cancers. The trial is currently recruiting participants, and it is open to individuals aged 6 months and older who have cancer cells expressing CD7.

To be eligible for this trial, participants need to be in relatively good health, with a performance status score indicating they can carry out daily activities, and they should expect to live for at least three more months. They must also meet specific health criteria, including normal function of organs like the liver and kidneys. However, people with severe health issues, active infections, or those who are pregnant cannot participate. If someone joins the trial, they can expect to receive the new treatment and be closely monitored throughout the study to see how their body responds. This trial represents a promising step in exploring new treatments for challenging blood cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age older than 6 months.
• • 2. Confirmed expression of CD7 and additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry.
• • 3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months.
• • 4. 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.
• • 5. Hgb≥80g/L.
• • 6. No cell separation contraindications.
• • 7. Abilities to understand and the willingness to provide written informed consent.
• Exclusion Criteria:
• • 1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
• • 2. Active bacterial, fungal or viral infection not controlled by adequate treatment.
• • 3. Known HIV or hepatitis C virus (HCV) infection.
• • 4. Pregnant or nursing women may not participate.
• • 5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
• • 6. Previous treatment with any gene therapy products.
• • 7. Patients, in the opinion of investigators, may not be able to comply with the study.