Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia

NCT06027853 | Recruiting Phase 1

• 1 other identifier: QH-CLL1-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 target CAR iPSC NK cells in patients with relapsed/refractory AML

Conditions

AML, Adult

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  Safety and Tolerability

  28 Days from first dose of iPSC NK cell infusion

• Incidence of subjects with Dose Limiting Toxicities within each dose level cohort

  Tolerability

  28 Days from first dose of iPSC NK cell infusion

Secondary Outcomes (1)

• Determination of the pharmacokinetics (PK) of iPSC NK cells in peripheral blood

  Up to approximately 2 years after last dose of iPSC NK cell infusion

Study Arms (1)

CAR-NK cell therapy in Adult subjects with r/r AML

EXPERIMENTAL

CAR-NK cell therapy in Adult subjects with r/r AML

Drug: CLL1 CAR-NK cell injection

Interventions

CLL1 CAR-NK cell injection DRUG

Drug: CLL1 NK cell therapy Drug: Cyclophosphamid Lympho-conditioning Agent Drug: Fludarabine Lympho-conditioning Agent Drug: VP-16 Lympho-conditioning Agent

CAR-NK cell therapy in Adult subjects with r/r AML

Eligibility Criteria

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

You may qualify if:

• ≥18 years old.
• Confirmed diagnosis of r/r AML
• CLL1 expression is positive in AML blasts.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks.
• Adequate organ and marrow function, as defined below:
• Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft- Gault formula) ≥ 50 mL/min;
• Total bilirubin (TBIL) ≤ 2 x the ULN;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN;
• International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
• Females of childbearing potential must have a negative serum pregnancy test.
• Donor specific antibody (DSA) is negative: MFI \<= 2000.
• Provision of signed and dated informed consent form (ICF).

You may not qualify if:

• Allergic to drug used in this study.
• Subjects received any antitumor therapy as follows, prior to first NK infusion:
• Systemic steroid therapy within 3 days (except physiological replacement therapy);
• Systemic antitumor therapy within 2 weeks or at least 5 half-lives, whichever is less;
• Radiotherapy within 4 weeks;
• Donor lymphocyte infusion within 6 weeks;
• Intrathecal treatment within 1 week;
• CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months;
• History of allogeneic stem cell transplantation.
• Received the vaccine within 4 weeks prior to the first infusion and/or expected to require vaccination from the study period to 12 weeks after the last infusion.
• Active central nervous system Leukemia.
• Acute Promyelocytic Leukemia (APL).
• History of other malignant tumors, except for those who have achieved complete remission more than 5 years after radical treatment without any signs of recurrence.
• Active autoimmune diseases.
• History of central nervous system disease or meningeal involvement such as epilepsy, paralysis, aphasia, stroke, etc.

Sponsors & Collaborators

• Zhejiang University: lead
• Hangzhou Qihangene Biotech Co.,Ltd.: collaborator

Study Sites (1)

Clinical research ethics committee of the first affiliated hospital, college of medicine, zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

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

• He Huang, MD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, MD

CONTACT

+8613605714822; hehuangyu@126.com

Yongxian Hu, MD

CONTACT

+8615957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: September 10, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)