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The clinical study of CAR-T cells in the treatment of acute myeloid leukemia

The clinical study of CAR-T cells in the treatment of acute myeloid leukemia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041054
Enrollment
Unknown
Registered
2020-12-17
Start date
2020-12-31
Completion date
Unknown
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia

Interventions

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Compliance with patients with refractory and relapsed acute myeloid leukemia; the definition of refractory is: (1) Treat patients who have not achieved partial remission after 2 courses of treatment with a standard remission induction program. (2) Relapse within 6 months after the first remission is also called early relapse. (3) Those who relapsed 6 months after the first remission, but failed to treat again with the original remission induction program. (4) Relapsed multiple times. Recurrence is defined as: patients who have achieved complete remission after treatment, with more than 5% of leukemia cells in the bone marrow, also known as intramedullary recurrence; or the appearance of leukemia lesions outside the bone marrow, also known as extramedullary recurrence (usually in the central nervous system, Testicular leukemia is the most common); 2. The diseased cells were confirmed to express CLL1/CD33/CD123/NKG2D/LILRB2(CD85d)/LILRB4 (CD85k)/ADGRE2/CCR1 targets; 3. KPS > 60 points; 4. The expected survival time is more than 3 months; 5. Gender is not limited, age 2-75 years old; 6. Patients who are clinically diagnosed as high-risk type, relapse and refractory type, or who do not have the conditions to receive standard treatment; 7. No serious mental disorders; 8. Sufficient heart, liver and kidney function (a. Liver function: ALT/AST = 95%; d. Heart function: left ventricular ejection fraction (LVEF) >= 40%;); 9. There are no other serious diseases that conflict with this plan (such as autoimmune diseases, immunodeficiency, organ transplantation); 10. Able to cooperate with trial management and follow-up; 11. The patient voluntarily participated in the study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) History of other malignant tumors; (2) Uncontrolled active infection; (3) Those with underlying diseases that require systemic application of glucocorticoids; (4) Acute and chronic GVHD; (5) T cell inhibitor therapy; (6) Women during pregnancy and lactation; (7) Patients with hepatitis B during the active period; (8) Other conditions deemed unsuitable to participate in the study by other researchers (HIV infection, intravenous drug addicts, etc.), or other conditions that affect the analysis of the results of this clinical study.

Design outcomes

Primary

MeasureTime frame
Safety;

Secondary

MeasureTime frame
Overall remission rate;Progression Free Survival;

Countries

CHINA

Contacts

Public ContactZhao Mingfeng

Tianjin First Central Hospital

mingfengzhao@sina.com+86 13752640369

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 13, 2026