Acute Myeloid Leukemia Clinical Trial
Official title:
TAA6 Cell Injection In The Treatment of Patients With Relapsed / Refractory Acute Myeloid Leukemia
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)
Status | Recruiting |
Enrollment | 5 |
Est. completion date | December 2023 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Anhui Provincial Hospital | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
PersonGen BioTherapeutics (Suzhou) Co., Ltd. | Anhui Provincial Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ORR 3 ORR 3 | 3-month objective response rate | three months after CAR-T cells infusion |
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