Allogenic CD123-CAR-NK Cells in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia

NCT05574608 | Unknown Early Phase 1

• 1 other identifier: CAR-NK123-JD
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The CD123-Targeted CAR-NK cell therapy is a new treatment that is being investigated for treatment of acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety of CD123-CAR NK cells given to these patients.

Conditions

Acute Myeloid Leukemia Refractory; Acute Myeloid Leukemia Recurrent

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicities (DLTs)

  1 Months

• Treatment-emergent adverse events

  3 months

• Treatment-related adverse events

  3 months

Secondary Outcomes (6)

• Complete response (CR)

  3 months

• Progression free survival (PFS)

  12 months

• Overall Survival (OS)

  12 months

• Proportion of subjects with minimal-residual disease (MRD) negative response

  3 months

• The area under the concentration time-curve (AUC) of CD123-CAR-NK cells

  3 Months

Study Arms (1)

Experimental: Experimental: CD123-CAR-NK.

EXPERIMENTAL

The relapsed/refractory AML patients will receive allogenic CD123-Targeted CAR-NK cells infusion (1x10\^9, 1-2x10\^7/kg) after precondition chemotherapy.

Biological: CD123-CAR-NK cells

Interventions

CD123-CAR-NK cells BIOLOGICAL

CD123-CAR-NK is an allogenic CD123-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy.

Experimental: Experimental: CD123-CAR-NK.

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old, no gender or race;
• Expected survival period ≥ 3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
• The diagnosis of AML with bone marrow biopsy, immunohistochemistry or Flow cytometry definitively positive for CD123 and met one of the following criteria:
• A. Diagnostic criteria for relapsed AML: after complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration; B. Diagnostic criteria for refractory AML: naive patients who were ineffective after 2 courses of standard regimens; patients relapsed within 12 months who underwent consolidation and intensive therapy after CR; patients relapsed after 12 months but were ineffective after conventional chemotherapy; Patients with two or more relapses; patients with persistent extramedullary leukemia; C. Patients eligible for relapsed or refractory AML remained minimally residual disease positive after salvage therapy
• Adequate organ function:
• A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL/min; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%;
• Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.;
• Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• Central nervous system involved;
• Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide;
• Systemic use of hormones within 2 weeks prior to enrollment (except for patients with inhaled corticosteroids);
• Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.
• History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;
• Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;
• Women who are pregnant (urine/blood pregnancy test positive) or lactating;
• Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness;
• \. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead
• Beijing JD Biotech Co. LTD.: collaborator

Study Sites (1)

The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

Study Officials

• Liangding Hu, Docotr

  The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liangding Hu, Doctor

CONTACT

+86 01066947171; huliangding@sohu.com

Yao Sun, Doctor

CONTACT

+86 01066947172; suny320@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluate the safety of JD023 injection.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 10, 2022
• Study Start: October 1, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2024
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)