TAA6 Cell Injection In The Treatment of Patients With Relapsed / Refractory Acute Myeloid Leukemia

NCT04692948 | Unknown

• 1 other identifier: PG-CART-TAA6-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study of TAA6 cell injection in the treatment of patients with relapsed / refractory Acute Myeloid Leukemia . The purpose is to evaluate the safety and effectiveness of CD276 targeted autologous chimeric antigen receptor T cells infusion in patients with relapsed / refractory CD276 positive Acute Myeloid Leukemia.（TAA6 cell injection is a T cell targeting CD276 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)

TAA6 cell injection

EXPERIMENTAL

Drug: TAA6 cell injection（Targeting CD276 autologous chimeric antigen receptor T cells） 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.

Other: Chimeric antigen receptor T cells (car-t)

Interventions

Chimeric antigen receptor T cells (car-t) OTHER

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.

Also known as: TAA6 cell injection

TAA6 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 (including the cut-off value), and the gender was not limited;
• The expected survival time ≥ 12 weeks;
• ECOG score 0-2;
• After the standard treatment, the disease relapsed or progressed, and the researchers judged that there was no other positive effect Standard treatment plan;
• The liver and kidney function and cardiopulmonary function meet the following requirements:
• Creatinine ≤ 1.5 ULN;;
• LVEF ≥ 45%;
• Blood oxygen saturation \> 91%;
• Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN;
• Able to understand the trial and have signed the informed consent.

You may not qualify if:

• Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy;
• In addition to 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;
• The patients with HBV (HCV) positive and HBV (HCV) positive in peripheral blood were detected for HBV (HCV) positive Syphilis was positive;
• Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), severe arrhythmia;
• Unstable systemic diseases judged by researchers: 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 planning pregnancy within 1 year after cell reinfusion or male subjects whose partners plan to conceive within 1 year after cell reinfusion;
• Patients who had received car-t therapy or other gene modified cell therapy before screening;
• Subjects who were receiving systemic steroid therapy within 7 days before screening or who were judged by the researcher to need long-term systemic steroid therapy during the 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 screening;
• According to the judgment of the researchers, it does not conform to the condition 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

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

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: December 28, 2020
• First Posted: January 5, 2021
• Study Start: December 9, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

CN (1)