NK Cell Infusion for Patients With Acute Myeloid Leukemia

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Natural killer (NK) cells exert antitumor effects via their cytotoxic and cytokine-secreting capacity without present of clinical symptoms. In recent years, with the continuous advancement of in vitro expansion methods, the application of good quality management technology, NK cells could be clinical grade expanded without the need for pre-purification, feeder-free, and serum-free culture. In this clinical trial the investigators want to demonstrate the safety and efficacy chemotherapy combined with donor-derived in vitro activated NK cells infusion for high risk AML patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborator: The University of Science and Technology of China
• Treatments: Cyclophosphamide; Fludarabine

Criteria

Inclusion Criteria:

1. AML patients receiving standard NCCN induction and consolidation chemotherapy;

2. Age> = 18 years old;

3. Relapsed and refractory AML: continued non-remission after induction and consolidation chemotherapy with NCCN standard protocol, or relapse after remission, or continued MRD positive;

4. MDS-RAEB, MDS-AML, MPD-AML;

5. ECOG≤3;

6. No serious organ dysfunction within 2 weeks before treatment:

1. Heart: no arrhythmia and LVEF≥50% and no pericardial effusion;

2. Liver: liver function <2 times the upper limit of ALT and <1.5 times the upper limit of total bilirubin, no active hepatitis;

3. Kidney: serum creatinine <1.5 mg / dl; or if serum creatinine exceeds the upper limit, serum creatinine clearance should be CrCl> 50 ml / min;

4. indoor fingertip blood oxygen saturation ≧ 92%;

7. Expected survival time ≥ 3 months;

8. The interval between re-induction therapy and NK cell therapy is at least 2 weeks, and the toxic and side effects of all induction remission treatments have disappeared; if the patient is receiving non-invasive chemotherapy, such as hydroxyurea, low-dose cytarabine, before receiving this program Should be discontinued before;

9. All patients and donors are willing to join this clinical trial and sign informed consent.

Exclusion Criteria:

1. Combined with a history of other malignant tumors <5 years (except cured skin basal cell carcinoma, cured cervical carcinoma in situ and gastrointestinal tumors confirmed to be cured by endoscopic mucosal resection);

2. Have received bone marrow or organ transplant;

3. Those who are allergic to the biological agents used in this treatment;

4. active infection;

5. Those who received other cell treatments such as DLI, CMV-CTL, EBV-CTL;

6. HBV carriers;

7. Patients with extramedullary recurrence;

8. Chest radiographic examination to determine patients with pulmonary inflammation;

9. Researchers do not consider it appropriate to participate in this trial.