Clinical trial · Interventional
CAR-T Cells Therapy in Relapsed/Refractory Acute Myeloid Leukemia
The Prospective, Multi-center And Single-arm Clinical Study of Chimeric Antigen Receptor T(CAR-T) Cells Therapy in Relapsed/Refractory Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The therapeutic effect was not as expected
Summary
Brief summary (as posted)
Acute myeloid leukemia (AML) is a group of genetically highly heterogeneous malignant disease . The disease is the most common type of adult acute leukemia. Overall survival (OS) was less than 50% in 5 years. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy. The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized, although it start late, several clinical trials have been register in ClinicalTrials.gov.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Acute Myeloid Leukemia(AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART therapy in Acute myeloid leukemia(AML) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CART therapy in Acute myeloid leukemia
- description
- In order to assess the safety and validity of using CAR-T therapy refractory/relapsed acute myeloid leukemia（AML）patients with one kind of CD38-CART/CD33-CART/CD56-CART/CD123-CART/CD117-CART/CD133-CART/CD34-CART/Mucl-CART,subjects will receive 10\^6-10\^7/Kg transduced CAR T cells at one time.
- interventionNames
- Biological: CART therapy in Acute myeloid leukemia(AML)
Primary outcomes (1)
- measure
- Adverse events that Are related to treatment
- timeFrame
- 2 years
- description
- Determine the toxicity profile of the CD38/CD33/CD56/CD123/CD117/CD133/CD34/ Mucl-targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
Show eligibility criteria text
Inclusion Criteria: 1. Relapsed/Refractory AML patients 2. Positive for any of CD33, CD38, CD56, CD117, CD123, CD34, or Muc1.(cytology, genetic testing) 3. Estimated survival time is more than 3 months in multiple myeloma,and Karnofsky Performance Status（KPS) score is more than 80. 4. No cytapheresis and cell separation contraindication. 5. Hemoglobin is more than 80 gram per litre. 6. The function of important organ was satisfied:(1)cardiac ultrasound indicated that cardiac ejection fractions is more than 50%（EF≥50%）, and the electrocardiogram showed no obvious abnormality;(2)Blood oxygen saturation is more than 90%（SpO2≥90%）;(3)Creatinine（Cr） is less than 2.5 times the upper limit of normal;(4)Alanine transaminase（ALT）and glutamic-oxalacetic transaminase（AST）is less than 3 times the upper limit of normal,and total bilirubin is less than 2 milligram per deciliter(TBil≤2.0mg/dL). 7. After discussion by the expert group, the patient's condition was analyzed and combined with the general physical condition of the patient, the benefit of participating in the clinical trial was greater than the risk. 8. Volunteered for this clinical trail and signed a consent form . 9. Currently, chemotherapy and approved targeted therapies are ineffective for the patients.Or patients cannot tolerate current chemotherapy. Exclusion Criteria: 1. Active other disease and cannot control after treatment. 2. Patients with actively infection of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV). 3. Severe psychiatric disorder or other disease in central nervous system. 4. Patients are infected with fungus,bacteria or virus,and are difficult to control after treatment. 5. Patients with infection of HIV . 6. Pregnant or lactating women. 7. Patients who have Graft-Versus-Host Disease (GVHD) should receive systemic administration of immunosuppressive agents. 8. Patients have received other genetic therapy products. 9. Patients who have received systemic administration of glucocorticoid agents in one week before CART therapy. 10. Any situation may do harm to the subjects or interfere the results. 11. Have had Prolonged QT interval or severe heart disease in the past.
References
Publications (0)
Data not yet available