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

Acute Myeloid Leukemia Clinical Trial

Official title:

Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in Refractory/Recurrent Acute Myeloid Leukemia: a Single-arm, Non-blind Clinical Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05943314
• Other study ID #: BG-CT-21-001
• Status: Withdrawn
• Phase: N/A
• Start date: July 12, 2023
• Est. completion date: August 28, 2023

Study information

• Verified date: October 2023
• Source: Guangzhou Bio-gene Technology Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 28, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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

Locations

Country	Name	City	State
China	Fujian Provincial Children's Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Bio-gene Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cytokine level after CLL1/+CD33 CAR-T infusion	Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion.	CAR T cell infusion before and 12 months after infusion
Primary	The change characteristics of chimeric antigen receptor(CAR)-T cell number in patients after infusion.	Track CAR-T cells expansion in patients after infusion by flow cytometry	CAR T cell infusion before and 12 months after infusion
Primary	The change characteristics of chimeric antigen receptor(CAR)-T cell copy number in patients after infusion.	Track CAR-T cells expansion in patients after infusion by Real-time Quantitative Polymerase Chain Reaction(qPCR)	CAR T cell infusion before and 12 months after infusion
Secondary	Event-free survival	Counting from the beginning of cell transfusion until treatment failure, recurrence, or death (various causes). Subjects without any of these events were counted up to the last follow-up examination date. For patients without CR or CRi, EFS is calculated from the beginning of cell transfusion until disease progression or death. Based on the initial event.	Up to 12 months after CLL1/+CD33 CAR-T infusion
Secondary	Overall survival	Death from any cause from the beginning of cell transfusion	Up to 12 months after CLL1/+CD33 CAR-T infusion
Secondary	Duration of Overall Response	The time from the start of cell infusion when CR or PR is first achieved to disease progression.	Up to 12 months after CLL1/+CD33 CAR-T infusion
Secondary	MRD negative rate	The rate of MRD negative subjects was determined by flow cytometry.	Up to 12 months after CLL1/+CD33 CAR-T infusion