Induced Pluripotent Stem Cells Derived Natural Killer Cells Therapy for Refractory and Relaps Acute Myelogenous Leukemia

NCT06702098 | Not Yet Recruiting Early Phase 1

• 1 other identifier: Ruixin Biotech
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study on the use of iNK cells for the treatment of refractory relapsed acute myeloid leukemia.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

iNK cells; R/R AML; iPSCs

Outcome Measures

Primary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events

  12 months

• MRD negative rate

  12 months

• Progression-free Survival

  12 months

• Overall survival

  12 months

Secondary Outcomes (1)

• Determination of chimerism of iNK cells in peripheral blood of subject.

  12 months

Study Arms (1)

Cell therapy group

EXPERIMENTAL

Intravenous infusion of iNK cells is given to the subject, 5\*108 to 1\*109 cells/dose, two doses per week, a total of 8 doses. And then 1\*109 cells/dose, one doses every 4 weeks , a total of 5 doses.

Drug: iNK cells

Interventions

iNK cells DRUG

Induced pluripotent stem cells derived NK cells.

Cell therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must satisfy the following criteria to be enrolled in the study.
• Patient is ≥ 18 and ≤ 80 years of age at the time of signing the Study informed consent form (ICF).
• Patient understands and voluntarily signs the Study ICF prior to any study-related assessments/procedures are conducted.
• Patient has eligible disease status:
• Primary or Secondary acute myeloid leukemia (AML) Patients in first of second Morphological Complete Remission (CR), Morphological Complete Remission with incomplete hematologic recovery (CRi), or Morphologic Leukemia-free State (MLFS) as defined by the European LeukemiaNet (ELN) recommendations for AML Response Criteria (Dohner, 2017).
• R/R diagnosis based on confirmed diagnosis with local pathology report following any reinduction/ salvage therapy ELN guidelines.
• Relapsed AML are defined as having relapsed after achieving ≥ 1 CR, including relapse after allogeneic stem cell transplantation (≥ 2 months after transplant).
• Refractory AML, defined as not achieving CR, CRi, or MLFS after 2 or more cycles of induction therapy (primary refractory) or not achieving CR after treatment for relapsed AML.
• Secondary AML (MDS transformation): Secondary AML patients are eligible to participate if they have received a minimum of one prior line of treatment for AML.
• Treatment-related AML: Treatment-related AML patients are eligible to participate if they have received a minimum of one prior line of treatment for AML.
• No active infection.
• No heart , liver and kidney functioninsufficiency.
• No central nervous system leukemia.

You may not qualify if:

• Subject meets one of the following criteria. 1.1History of CAR-T treatment with third degree CRS. 1.2 History of NK cell and CIK cell immunotherapy.
• Serious cardiovascular and cerebrovascular diseases. 2.1 Severe heart rhythm or conduction abnormalities, corrected QT interval (QTc)≥480 ms.
• Complete left bundle branch block, second- or third-degree atrioventricular block; 2.3 Severe, uncontrolled cardiac arrhythmias requiring medication. 2.4 New York Heart Association (NYHA) class II or above congestive heart failure.
• Left ventricular ejection fraction (LVEF) \<50% in color Doppler echocardiography.
• History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, severe pericardial disease, ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment.
• Previous or present concomitant other malignancies (except for basal cell carcinoma of the skin, non-melanoma and non-melanoma, carcinoma in situ of the breast/cervix that have been effectively controlled, and other malignancies that have been effectively controlled without treatment in the past five years).
• Uncontrollable systemic disease(e.g. uncontrolled hypertension, diabetes, etc).
• Pregnant women, lactating females, patients who refuse to use effective contraception during the study.
• history of severe neurological or psychiatric illness.
• Positive for hepatitis B surface antigen.
• Patients who are judged by the investigator to be unsuitable for participating in this study.

Sponsors & Collaborators

• Guangzhou Ruixin Biotechnological Co., LTD: lead
• Fifth Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Guangzhou Ruixin Biotechnology Co., Ltd

Guangzhou, Guangdong Province, China, 523786, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Huo Tan, MD

  Fifth Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Runhui Zheng, MD

  Fifth Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Liu J Jianbo Liu, MD

CONTACT

+86-020-85959142; 332520646@qq.com

Xiaodan Luo, MD

CONTACT

+86-020-85959142; jackeny@163.com

Study Design

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

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 22, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 24, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee(learned intermediary) identified for this purpose.

Locations

CN (1)