Actively Recruiting
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma
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-lymphoma
CONDITIONS
Official Title
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed CD5-positive T-cell non-Hodgkin lymphoma according to 2016 WHO classification
- Relapsed or refractory T-cell non-Hodgkin lymphoma with one of the following: no remission or relapse after second-line or more chemotherapy; primary drug resistance; relapse after autologous hematopoietic stem cell transplantation
- CD5 expression rate greater than 90%
- At least one evaluable tumor lesion according to Lugano 2014
- Total bilirubin C51 mol/L, ALT/AST C 3 times upper limit of normal, creatinine C 176.8 mol/L
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiography
- Pulse oxygen saturation of 92% or higher
- Estimated life expectancy of at least 12 weeks
- ECOG performance status of 0 to 2
- Pregnant or lactating women, or patients with fertility willing to use effective contraception for at least 6 months after last cell infusion
- Voluntary participation with informed consent
You will not qualify if you...
- History of epilepsy or other central nervous system disorders
- Electrocardiogram showing prolonged QT interval or severe heart diseases such as severe arrhythmia
- Active infection with hepatitis B, C, or E virus
- Active untreated infections
- Prior use of any gene therapy products
- Recent anti-tumor treatments within specified washout periods: systemic corticosteroids within 72 hours (except low-dose physiological replacement), small molecule targeted therapy within 72 hours, systemic chemotherapy within 2 weeks (except pretreatment), radiotherapy within 4 weeks
- Proliferation rate less than 5 times response to CD3/CD28 co-stimulation
- Any condition deemed unsuitable for trial participation by investigator
- Any situation increasing risk to subjects or interfering with trial results as judged 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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