NKG2D CAR-NK Cell Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT05247957 | Terminated

• 1 other identifier: CARNK-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will explore the maximum tolerated dose of cord blood NKG2D CAR-NK in the treatment of recurrent refractory acute myeloid leukemia in a dose-escalation manner, and observe its clinical safety and efficacy.

Conditions

Safety and Efficacy

Keywords

NKG2D CAR-NK; Relapsed or Refractory Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity

  To evaluate the clinical safety and short-term efficacy of NKG2D ligand-specific umbilical cord blood CAR-NK cells in the treatment of patients with relapsed refractory acute myeloid leukemia by intravenous infusion

  28 days

• Maximal Tolerable Dose

  tolerability evaluationtransplantation after intravenous infusion of NKG2D ligand-specific umbilical cord blood CAR-NK cells for patients with relapsed refractory acute myeloid leukemia

  28 days

Secondary Outcomes (1)

• leukemia-free survival#LFS#

  52weeks

Study Arms (1)

NKG2DL-specific CAR-NK cells

EXPERIMENTAL

Experimental: NKG2DL-specific CAR-NK cells, 2 infusions on Day 0 and Day 7 After preconditioning with chemotherapy, NKG2DL-specific CAR-NK cells will be evaluated

Biological: CAR-NK cells

Interventions

CAR-NK cells BIOLOGICAL

NKG2DL-specific CAR-NK cells, 2 infusions on Day 0 and Day 7

Also known as: NKG2DL-specific CAR-NK cells

NKG2DL-specific CAR-NK cells

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 10 years old and ≤ 75 years old, male or female;
• Meet the diagnostic criteria for recurrent AML: detection of leukemia cells after complete remission (CR) or \>0.1% of leukemia cells in bone marrow, including recurrence after allogeneic hematopoietic stem cell transplantation, or extramedullary infiltration of leukemia cells;
• Initial cases with failure of 2 lines of standard treatment; patients who relapsed within 12 months after consolidation intensification after CR; recurrence in 12 months and no respond to conventional chemotherapy; 2 or more recurrences; persistent extramedullarial leukemia;
• Patients currently have no effective treatment options, such as chemotherapy or allogeneic hematopoietic stem cell transplantation, or patients voluntarily choose to infuse NKG2D CAR-NK cells as the first treatment option;
• Physical status assessment (ECOG-PS) of the Eastern Oncology Collaborative Group is 0-2 points;
• Estimated survival \> 3 months
• Flow cytometry check for NKG2D ligand expression on the surface of cancer cells for a reference of selecting patients
• The main organs of the patient are well functioned: (1) cardiac function: no heart disease or coronary heart disease, the patient's cardiac function grade 1-2; (2) liver function: TBIL≦3ULN, AST≦2.5ULN, ALT≦2.5ULN; (3) Renal function: Cr≦1.25ULN;
• The patient's peripheral superficial vein can meet the needs of intravenous injection;
• No other serious diseases that conflict with this protocol (e.g., autoimmune diseases, immunodeficiency, organ transplantation);
• No history of other malignant tumors;
• Women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraception during both the trial and for 3 months after the test;
• Subjects have negative HIV, HBV, HCV, syphilis serology test results
• Written informed consent form must be signed before enrollment.

You may not qualify if:

• Acute promyelocytic leukemia (type M3);
• Patients with cardiac insufficiency, patients with hepatic and renal insufficiency;
• Those who need treatment with other malignant tumors;
• Poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>90 mmHg) or clinically significant cardiovascular and cerebrovascular diseases such as cerebrovascular accident (within 6 months before signing the informed consent form), myocardial infarction (within 6 months before signing the informed consent), unstable angina, congestive heart failure, or severe arrhythmias that cannot be controlled with drugs or have a potential impact on research treatment;
• Also suffering from other hematologic diseases (such as hemophilia, myelofibrosis, etc., which researchers consider unsuitable for inductees);
• Diffuse vascular internal coagulation;
• Concomitant serious infection or other serious underlying medical condition;
• Have immunodeficiency and autoimmune diseases;
• Have severe allergic diseases;
• Clinical symptoms of brain dysfunction or severe mental illness that can not understand or follow the research protocol;
• Have participated in clinical trials of other drugs within 4 weeks or within 21 days of surgery;
• Have received cell therapy in the previous 1 month;
• Have received hormonal drug therapy in the previous 14 days;
• Known HIV-positive patients or hepatitis B and C patients and syphilis patients;
• Have received organ transplants (excluding stem cell transplant patients);

Sponsors & Collaborators

• Hangzhou Cheetah Cell Therapeutics Co., Ltd: lead

Study Sites (1)

Hebei Yanda Lu Daopei Hospital

Sanhe, Hebei, China

Location

MeSH Terms

Conditions

Recurrence; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Peihua Lu, MD

  Hebei Yanda Lu Daopei Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 21, 2022
• Study Start: October 13, 2021
• Primary Completion: December 12, 2022
• Study Completion: December 20, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)