Actively Recruiting
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL
Led by Zhejiang University · Updated on 2024-10-09
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL
CONDITIONS
Official Title
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with CD5 positive T-Acute Lymphoblastic Leukemia according to NCCN 2020 guidelines
- Relapsed or refractory CD5+ T-ALL, including no complete remission after standard chemotherapy, relapse within 12 months after first remission, or multiple recurrences
- CD5 expression rate greater than 90%
- Bone marrow blasts over 5% by morphology and/or over 1% by flow cytometry
- Total bilirubin ≤ 51 µmol/L; ALT and AST ≤ 3 times upper normal limit; creatinine ≤ 176.8 µmol/L
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiography
- Oxygen saturation of 92% or higher
- Estimated life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Willingness to use effective contraception during the study and for 6 months after last cell infusion if of childbearing potential
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of epilepsy or other central nervous system diseases
- Prolonged QT interval or severe heart disease
- Active infection with hepatitis B, C, or E virus
- Active infections without cure
- Previous use of any gene therapy products
- Recent anti-tumor therapy: systemic corticosteroids within 72 hours (except low-dose physiological replacement), small molecule targeted therapy within 72 hours, systemic chemotherapy within 2 weeks, or radiotherapy within 4 weeks
- Proliferation rate less than 5 times response to CD3/CD28 co-stimulation
- Any condition judged by investigators as unsuitable for participation
- Any situation that may increase risk or interfere with trial results as determined by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, MD
CONTACT
Y
Yongxian Hu, MD
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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