Safety and Efficacy of Anti-FLT3 CAR- T Cell (TAA05 Cell Injection) in the Treatment of Relapsed/ Refractory Acute Myeloid Leukemia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a clinical trial of Anti-FLT3 CAR-T Cell (TAA05 Cell Injection) in the treatment of patients with relapsed / refractory acute myeloid leukemia. The purpose is to evaluate the safety and efficacy of anti-FLT3 CAR-T cells in patients with relapsed / refractory acute myeloid leukemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

⁃ Aged 18 \

• 70 years old (including boundary value), regardless of gender;

⁃ FLT-3 positive acute myeloid leukemia;

⁃ The expected survival time was more than 3 months;

⁃ ECOG score 0-2;

⁃ Refractory or relapsed AML patients after standardized treatment who meet any of the following criteria:

∙ After complete remission (CR), there were ≥5% leukemia cells or blast cells in the bone marrow(except for other reasons such as bone marrow regeneration after consolidation chemotherapy)in the peripheral blood and extramedullary lesions;

‣ Naive patients who are treated with 2 courses of treatment and are ineffective;

‣ Those who have relapsed within 12 months after CR after consolidation and intensive treatment;

‣ Those who relapse after 12 months but are ineffective after conventional chemotherapy;

‣ Subjects who experienced relapses twice or multiple times; with persistent extramedullary leukemia.

⁃ Kidney function, cardiopulmonary function, liver function, and coagulation function meet the following requirements:

∙ Creatinine ≤ 1.5 ULN;

‣ Left ventricular ejection fraction ≥ 50% and echocardiography does not reveal pericardial effusions and ECG does not reveal clinically significant abnormal bands;

‣ Blood oxygen saturation \> 92%;

‣ Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN; for the patients with ALT and AST abnormalities caused by disease which researchers judge (e.g. liver infiltrates or bile duct obstruction), the indicators of which can be relaxed to ≤5× ULN;

‣ PT/INR and PTT ≤ 1.5 ULN;

⁃ Patients understand the trial and have signed the informed consent form.

Locations
Other Locations
China
Wuhan Union Hospital
RECRUITING
Wuhan
Contact Information
Primary
Heng Mei
hmei@hust.edu.cn
027-8572600
Backup
Chenggong Li
chenggongli@hust.edu.cn
18868112136
Time Frame
Start Date: 2022-06-14
Estimated Completion Date: 2027-06-14
Participants
Target number of participants: 12
Treatments
Experimental: TAA05 Cell Injection
Fludarabine + Cyclophosphamide + TAA05 Cell Injection Patients will receive lymphodepletion with fludarabine (25 mg/kg) and cyclophosphamide (250 mg/kg) for 3 days on day -7\~-2, followed by the infusion of TAA05 Cell with the dose of 1×10\^8, 2×10\^8 or 4×10\^8 cells on day 0. If no dose-limited toxicity(DLT) emerges in the group, then the subsequent higher dose will be used in the next group. If DLT emerges in a single subject in any dose level, 3 more subjects will be enrolled to the same dose level. After the end of dose climbing, if the maximum dose group(MTD) is still not observed, the highest dose group is defined as MTD.
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

This content was sourced from clinicaltrials.gov