TAA05 Cell Injection in the Treatment of Recurrent / Refractory Acute Myeloid Leukemia

NCT05017883 | Unknown

• 1 other identifier: V2.0
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study of ytaa05 cell injection in the treatment of patients with recurrent / refractory acute myeloid leukemia.The purpose is to evaluate the safety and preliminary efficacy of FLT3 car-t cells in patients with recurrent / refractory FLT3 positive acute myeloid leukemia.#TAA05 cell injection is a T cell targeting FLT3 chimeric antigen receptor#

Conditions

CAR; Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• ORR 3 ORR 3

  3-month objective response rate

  three months after CAR-T cells infusion

Study Arms (1)

TAA05 cell injection

EXPERIMENTAL

TAA6 cell injection#Targeting FLT3 autologous chimeric antigen receptor T cells#

Drug: TAA05 cell injection

Interventions

TAA05 cell injection DRUG

Chimeric antigen receptor T cells (car-t) Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner,which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.

TAA05 cell injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 \~ 70 years old (including boundary value), regardless of gender;
• Acute myeloid leukemia with FLT3 positive (positive rate ≥ 30%) verified by flow cytometry or immunohistochemistry;
• The expected survival time was more than 12 weeks;
• ECoG score 0-2;
• Refractory or relapse after standardized treatment;
• Liver and kidney function and cardiopulmonary function meet the following requirements:
• Creatinine ≤ 1.5 ULN;
• Left ventricular ejection fraction ≥ 45%;
• Blood oxygen saturation \> 91%;
• Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN；
• Understand the test and have signed the informed consent form.

You may not qualify if:

• Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive agents;
• Malignant tumors other than acute myeloid leukemia within 5 years before screening, except fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and breast ductal carcinoma in situ after radical operation;
• hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference range; Hepatitis C virus (HCV) antibody positive and hepatitis C virus (HCV) RNA positive in peripheral blood; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis test positive;
• Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ grade III), severe arrhythmia;
• Unstable systemic diseases judged by the researcher: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
• Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);
• Pregnant or lactating women, female subjects who planned pregnancy within 1 year after cell reinfusion, or male subjects whose partners planned pregnancy within 1 year after cell reinfusion;
• Those who had received car-t therapy or other gene modified cell therapy before screening;
• Subjects who were receiving systemic steroid treatment within 7 days before screening or who were determined by the investigator to need long-term systemic steroid treatment during treatment (except inhalation or local use);
• Participated in other clinical studies within 3 months before screening;
• There was evidence of central nervous system invasion during subject screening;
• According to the judgment of the researcher, it does not conform to the situation of cell preparation;

Sponsors & Collaborators

• PersonGen BioTherapeutics (Suzhou) Co., Ltd.: lead
• Anhui Provincial Hospital: collaborator

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, 230000, 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

• Xingbing Wang

  No.1, Swan Lake Road, new administrative and Cultural District, Hefei City, Anhui Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingbing Wang

CONTACT

13856007984; wangxingbing@ustc.edu.cn

Huimin Meng

CONTACT

0551-65728070; huimin.meng@persongen.com.cn

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: August 17, 2021
• First Posted: August 24, 2021
• Study Start: July 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2025
• Last Updated: November 4, 2021

Record last verified: 2021-08

Locations

CN (1)