Universal CAR T therapy targeting CD7-positive blood cancers

Safety and Efficacy of Universal 4SCAR7U T Cell Therapy Targeting CD7-positive Hematological Malignancies

This study is testing a new type of CAR T cell therapy that targets a specific marker in certain blood cancers to see if it can help patients with these aggressive diseases.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 6 Months to 75 Years
• Sex: All
• Sponsor: Shenzhen Geno-Immune Medical Institute (other)
• Drugs / interventions: CAR T, CAR-T, chimeric antigen receptor
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT05995028 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, feasibility, and efficacy of universal CAR T cells designed to target CD7-positive hematological malignancies, including T-cell acute lymphoblastic leukemia, acute myeloid leukemia, and NK cell lymphoma. The study aims to understand how these CAR T cells function and persist in patients with these aggressive diseases. Participants will receive CD7-specific CAR gene-engineered T cells, which are modified to enhance their ability to attack cancer cells expressing the CD7 marker.

Who should consider this trial

Good fit: Ideal candidates for this study include patients over 6 months old with confirmed CD7 expression in their cancer cells and a good performance status.

Not a fit: Patients with severe illnesses or uncontrolled infections may not benefit from this study due to their inability to comply with the treatment protocol.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with CD7-positive hematological malignancies, potentially improving survival rates and outcomes.

How similar studies have performed: Other studies have shown promise in using CAR T cell therapies for hematological malignancies, but this specific approach targeting CD7 is relatively novel.

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.

Where this trial is running

Shenzhen, Guangdong

• Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Lung-Ji Chang, Ph.D

Conditions: T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, Acute Myeloid Leukemia, NK Cell Lymphoma, T-ALL, TCL, AML, NK lymphoma