Actively Recruiting
Evaluation of the Safety and Efficacy of Human CI-135 (FLT3) Targeted CAR-T Cell Injection for Relapsed or 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
Researchers are evaluating the safety, tolerability, and how the body processes and responds to a new treatment called anti-human CI-135 (FLT3) CAR-T Injection in patients with relapsed or refractory Acute Myeloid Leukemia (AML). This early-phase study also aims to observe the initial effectiveness of this therapy in this patient group. The study targets adults aged 18 to 70 years who have specific types of relapsed or resistant AML with FLT3 mutations or high FLT3 expression. The treatment involves infusing patients with their own genetically modified T cells, called Human Derived anti-CI135 CAR-T Injection, designed to target the FLT3 protein on leukemia cells. This is a single-arm, open-label, dose-escalation study, meaning all participants receive this investigational therapy and doses may be adjusted to find the optimal balance of safety and effect. The trial includes a treatment period followed by monitoring for side effects and treatment response. Participants will be closely monitored for dose-limiting toxicities within 28 days post-infusion. The study includes assessments of liver, kidney, heart, and lung function, along with performance status evaluations. Safety monitoring will include checking for infections, cardiovascular risks, and potential allergic reactions. Patients must be able to understand the study and provide informed consent, with survival expected to be greater than 12 weeks. The total study duration and follow-up details are designed to ensure careful observation of treatment effects and participant well-being.
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
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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.
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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