NCT05943314

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 12, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

June 9, 2023

Last Update Submit

October 31, 2023

Conditions

Acute Myeloid Leukemia

Keywords

AMLCLL1CD33

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Event-free survival

    Up to 12 months after CLL1/+CD33 CAR-T infusion

  • Overall survival

    Up to 12 months after CLL1/+CD33 CAR-T infusion

  • Duration of Overall Response

    Up to 12 months after CLL1/+CD33 CAR-T infusion

  • MRD negative rate

    Up to 12 months after CLL1/+CD33 CAR-T infusion

Study Arms (1)

CLL1/+CD33 CAR-T

EXPERIMENTAL

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

Biological: CLL1/+CD33 CAR-T

Interventions

CLL1/+CD33 CAR-TBIOLOGICAL

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

CLL1/+CD33 CAR-T

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The patient or his/her legal guardian volunteers for the trial and signs an informed consent form;
  • Age range 1-18 years;
  • 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 ;
  • 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% ;
  • The blood flow of peripheral superficial vein was unobstructed, which could meet the demands of intravenous drip and mononuclear cell collection;
  • ECOG score was 0-2.

You may not qualify if:

  • The patients had uncontrollable infectious diseases within 4 weeks before the enrollment;
  • Active hepatitis B/C virus;
  • HIV infection, treponema syphilis positive patients;
  • Pathological diagnosis of primary tumors other than acute myeloid leukemia;
  • Suffering from serious autoimmune diseases or immunodeficiency diseases;
  • The patient is allergic to antibodies or cytokines and other macromolecular biological drugs;
  • Pregnant or lactating women;
  • Patients who were considered ineligible for study for other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Provincial Children's Hospital

Fuzhou, Fujian, 350005, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Hui Zhang, doctor

    Children's Hospital of Fujian Province

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2023

First Posted

July 13, 2023

Study Start

July 12, 2023

Primary Completion

August 28, 2023

Study Completion

August 28, 2023

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

CN(1)