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

Primary Purpose

CAR, Acute Myeloid Leukemia

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Chimeric antigen receptor T cells (car-t)

About this trial

This is an interventional treatment trial for CAR

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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;
Able to understand the trial and have signed the informed consent.

Exclusion Criteria:

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;
Other researchers think that it is not suitable for inclusion.

Sites / Locations

Anhui Provincial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAA6 cell injection

Arm Description

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.

Outcomes

Primary Outcome Measures

ORR 3 ORR 3

3-month objective response rate

Secondary Outcome Measures

Full Information

NCT ID

NCT04692948

First Posted

December 28, 2020

Last Updated

March 4, 2021

Sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Collaborators

Anhui Provincial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04692948

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 9, 2019 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Collaborators

Anhui Provincial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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）

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CAR, Acute Myeloid Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TAA6 cell injection

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Chimeric antigen receptor T cells (car-t)

Other Intervention Name(s)

TAA6 cell injection

Intervention Description

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.

Primary Outcome Measure Information:

Title

ORR 3 ORR 3

Description

3-month objective response rate

Time Frame

three months after CAR-T cells infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; Other researchers think that it is not suitable for inclusion.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xingbing Wang

Phone

13856007984

wangxingbing@ustc.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Huimin Meng

Phone

0551-65728070

huimin.meng@persongen.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xingbing Wang

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anhui Provincial Hospital

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

xingbing wang, doctor

Phone

+86 18963789012

wangxingbing@ustc.edu.cn

12. IPD Sharing Statement

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

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