Actively Recruiting
Evaluation of the Safety and Efficacy of Human CI-135 (FLT3) Targeted CAR-T Cells Injection for Subjects with Relapsed/Refractory Acute Myeloid Leukemia
Led by Hrain Biotechnology Co., Ltd. · Updated on 2025-01-07
7
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
Sponsors
H
Hrain Biotechnology Co., Ltd.
Lead Sponsor
T
The First Affiliated Hospital of Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Safety and Efficacy of Human CI-135 (FLT3) Targeted CAR-T Cells Injection for Subjects with Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers aged 18 to 70 years, male or female, who understand and agree to participate and complete all study procedures
- Expected survival of more than 12 weeks
- Diagnosed with Acute Myeloid Leukemia by ELN 2017 criteria and meeting one of these: no remission after at least 3 induction therapy cycles; remission then relapse within 1 year; remission over 1 year but no remission after relapse chemotherapy; relapse after transplantation; or two or more relapses
- For certain patients with FLT3 mutations, must have had at least one tyrosine kinase inhibitor treatment without remission or relapsed after remission, unless unable to tolerate or contraindicated
- Positive for FLT3 mutation or FLT3 expression 35% or higher
- ECOG performance status score of 1-2
- Liver, kidney, heart, and lung functions within specified limits including GFR ≥60 ml/min/1.73 m², serum creatinine ≤2 times ULN, AST/ALT ≤3 times ULN, total bilirubin ≤1.5 times ULN, oxygen saturation >92%, LVEF ≥50%, no pericardial effusion, and no major ECG abnormalities
- Able to understand the study and sign informed consent
You will not qualify if you...
- Diagnosed with acute promyelocytic leukemia (APL M3)
- Presence of other uncontrolled cancers likely to interfere with safety or efficacy assessments
- Prior treatment with CAR-T cells or other genetically modified cell therapies
- Significant cardiovascular risks such as congestive heart failure, unstable angina, serious arrhythmias, recent coronary angioplasty, implantable cardiac defibrillator, or other major comorbidities impacting safety or study completion
- Positive for hepatitis B surface antigen or core antibody with detectable HBV DNA, positive hepatitis C antibody with detectable RNA, positive HIV antibodies, or positive syphilis test
- Positive for acute or chronic hepatitis C unless fully treated and virus undetectable post-treatment
- History of arterial or venous thrombosis within 3 months before enrollment
- History of graft-versus-host disease requiring systemic immunomodulators
- History of central nervous system diseases needing treatment such as uncontrolled seizures
- Uncontrolled active infections
- Known allergy to any components of the CI-135 CAR-T formulation or lymphodepletion drugs cyclophosphamide and fludarabine
- Currently pregnant, breastfeeding, or planning pregnancy within 1 year after infusion
- Other conditions judged unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
S
Suning Chen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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