Clinical Study on Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in the Treatment of Acute Myeloid Leukemia

NCT ID: NCT05943314

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2023-08-28

Brief Summary

This is a single-center, single-arm, open, intravenous drug administration of the safety and efficacy of clinical study.

Detailed Description

The primary objective of the clinical trial was to evaluate the safety and efficacy of single dose infusion of anti-CLL1 /+CD33 CAR T cells in patients with refractory/recurrent acute myeloid leukemia. A total of about 5 patients with refractory/recurrent acute myeloid leukemia were enrolled in this study, and the target dose range was 1.00~2.50x10^6/kgCAR-positive T cells.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CLL1/+CD33 CAR-T

The target dose range for subjects was set to be 1.00\~2.50x10\^6/kg CAR-positive T cells.

Group Type: EXPERIMENTAL

CLL1/+CD33 CAR-T

Intervention Type: BIOLOGICAL

CLL1/+CD33 CAR T is a type of CAR T cell therapy for patients with treating/relapsed acute myeloid leukemia.

Interventions

CLL1/+CD33 CAR-T

CLL1/+CD33 CAR T is a type of CAR T cell therapy for patients with treating/relapsed acute myeloid leukemia.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. The patient or his/her legal guardian volunteers for the trial and signs an informed consent form;

2. Age range 1-18 years;

3. Acute myeloid leukemia (AML) with CLL1 and CD33 markers (including secondary patients) was diagnosed by pathology, histology and flow cytometry, or complete hematologic remission could not be achieved after 1 course of chemotherapy for hematologic relapse after drug withdrawal ;

4. The main organ functions of the patients were good: (1) liver function: ALT/AST < 3 times the upper limit of normal (ULN) and bilirubin ≤34.2 μmol/l; (2) renal function: creatinine < 220 μmol/l; (3) lung function: oxygen saturation ≥95% ; (4) cardiac function: left ventricular ejection fraction (LVEF)≥40% ;

5. The blood flow of peripheral superficial vein was unobstructed, which could meet the demands of intravenous drip and mononuclear cell collection;

6. ECOG score was 0-2.

Exclusion Criteria

1. The patients had uncontrollable infectious diseases within 4 weeks before the enrollment;

2. Active hepatitis B/C virus;

3. HIV infection, treponema syphilis positive patients;

4. Pathological diagnosis of primary tumors other than acute myeloid leukemia;

5. Suffering from serious autoimmune diseases or immunodeficiency diseases;

6. The patient is allergic to antibodies or cytokines and other macromolecular biological drugs;

7. Pregnant or lactating women;

8. Patients who were considered ineligible for study for other reasons.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Bio-gene Technology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Zhang, doctor

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fujian Province

Locations

Fujian Provincial Children's Hospital

Fuzhou, Fujian, China

Countries

China

Other Identifiers

BG-CT-21-001

Identifier Type: -

Identifier Source: org_study_id