Status:
UNKNOWN
TAA6 Cell Injection In The Treatment of Patients With Relapsed / Refractory Acute Myeloid Leukemia
Lead Sponsor:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborating Sponsors:
Anhui Provincial Hospital
Conditions:
CAR
Acute Myeloid Leukemia
Eligibility:
All Genders
18-70 years
Phase:
NA
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 target...
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 myeloi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04692948
Start Date
December 9 2019
End Date
December 1 2023
Last Update
March 8 2021
Active Locations (1)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230000