Universal CAR-T Cells for treating Acute Myeloid Leukemia

Universal CAR T Cells for the Treatment of Acute Myeloid Leukemia

This study is testing a new off-the-shelf CAR T-cell therapy for people with relapsed or hard-to-treat Acute Myeloid Leukemia to see if it can help them quickly and effectively.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 6 Months to 75 Years
• Sex: All
• Sponsor: Shenzhen Geno-Immune Medical Institute (Academic / other)
• Drugs / interventions: CAR T, CAR-T, chemotherapy
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT05995041 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of universal CAR T-cell products targeting CLL-1, CD33, CD38, and CD123 in patients with relapsed and refractory Acute Myeloid Leukemia (AML). The approach aims to provide off-the-shelf CAR T-cell therapy, which can be administered quickly to patients with limited time due to severe disease progression. The study will also investigate the functionality and persistence of these universal CAR T cells in the patient's body. By using a universal product, the trial seeks to overcome challenges associated with traditional CAR T-cell therapies that require patient-specific customization.

Who should consider this trial

Good fit: Ideal candidates include patients over 6 months old with confirmed expression of CLL-1, CD123, CD38, and/or CD33 in their AML blasts.

Not a fit: Patients with severe illness or uncontrolled infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a rapid and effective therapeutic option for patients with difficult-to-treat AML.

How similar studies have performed: While CAR T-cell therapies have shown success in treating B cell malignancies, this approach for AML is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age older than 6 months.
2. Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts 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 active 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. The bone marrow AML burden (MRD) is above 50%.
8. 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 Acute Myeloid Leukemia; AML; Universal CAR T; CD33, CD123, CD38, CLL-1