Using CAR-T cells to treat acute myeloid leukemia

Clinical Study of Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Myeloid Leukemia

This study is testing if a new treatment using specially modified immune cells can help people with relapsed or stubborn acute myeloid leukemia feel better and improve their outcomes.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 2 Years to 75 Years
• Sex: All
• Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China (other)
• Drugs / interventions: CAR T, CAR-T
• Locations: 1 site (Kunming, Yunnan)
• Trial ID: NCT04923919 on ClinicalTrials.gov

What this trial studies

This clinical study aims to enroll 100 patients with relapsed or refractory acute myeloid leukemia (AML) to receive a single dose of autologous CAR T cells targeting specific leukemia markers. The safety and efficacy of this CAR T therapy will be assessed by monitoring adverse events and comparing patient outcomes to their previous standard treatments. Blood and bone marrow samples will be collected before and 12 months after the infusion to evaluate the activity and pharmacokinetics of the CAR T cells.

Who should consider this trial

Good fit: Ideal candidates include patients aged 2-75 with relapsed or refractory acute myeloid leukemia who have specific leukemia markers and a performance status score above 60.

Not a fit: Patients who do not express the targeted markers or have a life expectancy of less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat acute myeloid leukemia.

How similar studies have performed: Other studies using CAR-T cell therapy for hematological malignancies have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. The diagnosis of myeloid leukemia was clear;Refractory treatment was defined as: (1) 2 patients who did not achieve partial remission after treatment with standard induced remission regimens.② The patients who relapsed within 6 months after the first remission were also called early recurrence.③ The failure relapsed 6 months after the initial response, but was retreated with the original induced response regimen.(4) multiple relapse.Relapse is defined as: patients who achieve complete remission after treatment, more than 5% of leukemia cells in the bone marrow, also known as intramedullary recurrence;Or the presence of leukaemia outside the bone marrow, also known as extramedullary relapse (usually in the central nervous system, testicular leukemia is the most common);
2. Diseased cells were confirmed to express CD123, CLL1 and other targets;
3. KPS \> 60 points;
4. Expected survival of more than 3 months;
5. No gender limitation, age 2-75;
6. Patients clinically diagnosed as high-risk type, refractory type of recurrence or not eligible for standard treatment;
7. No serious mental disorders;
8. Sufficient heart, liver and renal function (a. Liver function: ALT/AST \< 3 times upper limit of normal value (ULN) and bilirubin ≤34.2μmol/L;B. Renal function: creatinine \< 220μmol/L;C. Lung function: indoor oxygen saturation ≥95%;D. Cardiac function: left ventricular ejection fraction (LVEF) ≥40%;);
9. No other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation) that are in conflict with this program;
10. Can cooperate with trial management and follow-up;
11. Patients voluntarily participated in the study and signed the informed consent

Exclusion Criteria:

1. History of other malignant tumors;
2. Uncontrolled active infection;
3. Patients with underlying diseases requiring systemic use of glucocorticoids;
4. Acute or chronic GVHD;
5. T-cell inhibitor therapy;
6. Pregnant and lactating women;
7. Patients with active hepatitis B;
8. Other conditions considered by the investigator to be inappropriate for the study (HIV infection, intravenous drug addiction, etc.), or other conditions that may affect the analysis of the results of the clinical study.

Where this trial is running

Kunming, Yunnan

• No.212 Daguan Road, Xishan District — Kunming, Yunnan, China (RECRUITING)

Study contacts

• Study coordinator: Wang Sanbin, Doctor

Conditions: Acute Myeloid Leukemia