A Study to Evaluate the Safety and Efficacy of CI-135 CAR-T Cell Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

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

This study is a single-arm, open-label, dose-escalating trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of anti human CI-135 (FLT3) CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory Acute Myeloid Leukemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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∙ Subjects must meet all of the following criteria to be enrolled:

• Subjects volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the trial procedures;

• Aged from 18 to 70 years (including cut-off value), Male and female;

• Expected survival \> 12 weeks;

• Previously diagnosed as Acute Myeloid Leukemia by ELN updated criteria (2017) and one of the following indicators that is satisfied:

‣ AML patients who have not achieved complete remission (CR) after at least three cycles of standard induction therapy, or

⁃ AML patients who achieved complete remission after induction therapy but relapsed within one year, or

⁃ AML patients who achieved complete remission after induction therapy for more than one year but did not achieve remission after one cycle of chemotherapy with the original regimen following relapse, or

⁃ AML patients who relapsed after transplantation, or

⁃ AML patients who experienced two or more relapses. Note: For patients meeting conditions a), b), or c) with FLT3 mutations, they must have undergone at least one treatment with a tyrosine kinase inhibitor (TKI) without achieving complete remission or have relapsed after achieving complete remission, except for those who cannot tolerate TKI therapy or have contraindications to TKI treatment.

• Positive for FLT3 mutation confirmed by leukemia cell genetic testing, or FLT3 expression ≥35%;

• ECOG performance status score of 1-2;

• Liver, kidney, heart, and lung functions meeting the following criteria:

‣ Glomerular filtration rate (GFR) ≥60 ml/min/1.73 m² or serum creatinine ≤2 times the upper limit of normal (ULN);

⁃ Serum AST and ALT ≤3 times of ULN, and total bilirubin ≤1.5 times the ULN;

⁃ Oxygen saturation \> 92%;

⁃ Left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion observed on ultrasound, and no clinically significant electrocardiographic abnormalities.

• Able to understand the study and sign the informed consent form.

Locations
Other Locations
China
First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Suning Chen, M.D.
chensuning@sina.com
86-13814881746
Time Frame
Start Date: 2022-01-26
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 7
Treatments
Experimental: Experimental: Anti CI-135 (FLT3) CAR-T Injection
Single administration: 0.5 \* 10\^6 CAR-T cells/kg, 1.0 \* 10\^6 CAR-T cells/kg
Related Therapeutic Areas
Sponsors
Leads: Hrain Biotechnology Co., Ltd.
Collaborators: The First Affiliated Hospital of Soochow University

This content was sourced from clinicaltrials.gov

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