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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04692948
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : March 8, 2021
Sponsor:
Collaborator:
Anhui Provincial Hospital
Information provided by (Responsible Party):
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Study Description
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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）

Condition or disease Intervention/treatment Phase
CAR Acute Myeloid Leukemia Other: Chimeric antigen receptor T cells (car-t) Not Applicable

Detailed Description:

AML is a malignant disease of myeloid hematopoietic stem / progenitor cells and the most common hematological malignancy. It is characterized by abnormal proliferation of primitive and immature myeloid cells in bone marrow and peripheral blood. In recent years, due to the aging of the population, the incidence of AML and MDS has been on the rise. What is also troubling us is that the incidence of treatment-related MDS and AML in children and adolescents with Hodgkin's disease, sarcoma, breast and testicular tumors, lymphoma and other patients who survive after treatment is also gradually increasing. Occupational exposure such as ionizing radiation and benzene and petrochemical are also related to the incidence of AML.

Car t therapy is the most effective and widely used in the treatment of all. B7-H3, also known as cd276, was first discovered in 2001. It is mainly expressed on the cell surface, such as activated dendritic cells, monocytes, T cells, B cells and NK cells. Studies have shown that B7-H3 can stimulate the expansion and killing of T cells, and may selectively stimulate the signal receptor of T cells. It is a promising target for AML immunotherapy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TAA6 Cell Injection In The Treatment of Patients With Relapsed / Refractory Acute Myeloid Leukemia
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TAA6 cell injection

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)
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 Name: TAA6 cell injection


Outcome Measures
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Primary Outcome Measures :
  1. ORR 3 ORR 3 [ Time Frame: three months after CAR-T cells infusion ]
    3-month objective response rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-70 (including the cut-off value), and the gender was not limited;
  2. The expected survival time ≥ 12 weeks;
  3. ECOG score 0-2;
  4. After the standard treatment, the disease relapsed or progressed, and the researchers judged that there was no other positive effect Standard treatment plan;

  5. The liver and kidney function and cardiopulmonary function meet the following requirements:

    1. Creatinine ≤ 1.5 ULN;;
    2. LVEF ≥ 45%;
    3. Blood oxygen saturation > 91%;
    4. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN;
  6. Able to understand the trial and have signed the informed consent.

Exclusion Criteria:

  1. Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy;
  2. 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;
  3. The patients with HBV (HCV) positive and HBV (HCV) positive in peripheral blood were detected for HBV (HCV) positive Syphilis was positive;
  4. 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;
  5. Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
  6. Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);
  7. 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;
  8. Patients who had received car-t therapy or other gene modified cell therapy before screening;
  9. 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);
  10. Participated in other clinical studies within 3 months before screening;
  11. There was evidence of central nervous system invasion during screening;
  12. According to the judgment of the researchers, it does not conform to the condition of cell preparation;
  13. Other researchers think that it is not suitable for inclusion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692948


Contacts
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Contact: Xingbing Wang 13856007984 wangxingbing@ustc.edu.cn
Contact: Huimin Meng 0551-65728070 huimin.meng@persongen.com.cn

Locations
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China, Anhui
Anhui Provincial Hospital Recruiting
Hefei, Anhui, China, 230000
Contact: xingbing wang, doctor    +86 18963789012    wangxingbing@ustc.edu.cn   
Sponsors and Collaborators
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Anhui Provincial Hospital
Investigators
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Principal Investigator: Xingbing Wang No.1, Swan Lake Road, new administrative and Cultural District, Hefei City, Anhui Province
More Information
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Responsible Party: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT04692948    
Other Study ID Numbers: PG-CART-TAA6-001
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms