Natural Killer Cells Infusion for Treating Acute Myeloid Leukemia Patients With Minimal Residual Disease

Acute Myeloid Leukemia Clinical Trial

Official title:

Phase I Clinical Trial of Haploid Donor-derived in Vitro Activated Natural Killer Cells Infusion for Patients With Minimal Residual Disease After Consolidation Therapy for Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04209712
• Other study ID #: DS2019070101
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
• Contact: Jiang ZHU
• Phone: +86-15900398802
• Email: zhujiang[@]icell.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial will evaluate the effectiveness and safety of haploid donor-derived in vitro activated natural killer(NK) cells infusion for Treating acute myeloid leukemia Patients With minimal residual disease.

Description:

Patients of acute myeloid leukemia after chemotherapy with MRD(minimal residual disease) will receive NK cell infusion combined with consolidation chemotherapy. The bone marrow morphology and MRD remission of the patients will be observed 15 days after the same treatment. All patients will be followed up for 1 year.

NK cells are prepared in Beijing iCELL Biotechnology Co.,Ltd, which is subsidiary to Shanghai iCELL Biotechnology Co.,Ltd.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 80 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with acute myeloid leukemia;

2. MRD after 2 course of standard chemotherapy;

3. No plan for hematopoietic stem cell transplantation;

4. Hemoglobin (Hb) >=60g/L, white blood cell count (WBC) >=2.5x10^9/L, platelet count >=30x10^9/L;

5. Patients have self-knowledge ability and can sign informed and voluntary consent forms;

6. Patients or their clients, guardians of pediatric patients signed the informed and voluntary consent form and joined the study.

Exclusion Criteria:

1. Intracranial hypertension or unconsciousness;

2. Symptomatic heart failure or severe arrhythmia;

3. Respiratory failure;

4. With other types of malignant tumor diseases;

5. T lymphocytic acute leukemia;

6. Diffuse intravascular;

7. Serum creatinine and / or urea nitrogen >=1.5 times the normal value;coagulation;

8. Serum total bilirubin >=1.5 times the normal value;

9. Sepsis or other difficult-to-control infections;

10. Uncontrollable diabetes;

11. severe mental disorders;

12. WHO physical status classification >=3;

13. People who are allergic to Interleukin-2;

14. Patients after organ transplant;

15. Pregnant and lactating women.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Neoplasm, Residual

Intervention

Biological:
• haploid allogeneic NK cell therapy
NK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2.

Locations

Country	Name	City	State
China	Hebei Yanda Ludaopei Hospital	Langfang	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	Hebei Yanda Ludaopei Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal Residual Disease (MRD)	MRD-negative is defined as <0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as >=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.	12 months
Secondary	Number of participants with adverse events	Evaluation of toxicities defined as any CTCAE (v. 4.03)	12 months