Actively Recruiting
A Clinical Study on the Safety and Effectiveness of 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
N/A
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CD5 CAR-T cell therapy in patients with relapsed or refractory CD5-positive T-cell non-Hodgkin lymphoma, also known as T-lymphoblastic lymphoma. This early phase 1 clinical study builds upon previous research confirming the safety of this therapy, aiming to further assess its effectiveness and gather additional safety data by expanding the number of participants to 30. Participants in this study will receive CD5 CAR-T cells through intravenous infusion. The treatment follows a dose escalation design with three dose levels tested using the standard 3+3 method. This approach helps determine the appropriate dosage while monitoring for safety and treatment response over time. During the study, patients will be closely monitored for dose-limiting toxicities up to 28 days after treatment and treatment-emergent adverse events for up to two years. Researchers will assess the overall response rate within 12 weeks, duration of remission up to one year, progression-free survival up to two years, and overall survival up to one year after infusion. Various laboratory tests, imaging, and clinical evaluations will be conducted to track patient progress and safety throughout the study period.
CONDITIONS
Brief 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 (T-NHL) according to the 2016 WHO classification
- Relapsed or refractory T-NHL with no remission or relapse after second-line or more chemotherapy, primary drug resistance, or relapse after autologous hematopoietic stem cell transplantation
- CD5 expression rate greater than 90%
- At least one evaluable tumor lesion according to Lugano 2014 criteria
- Total bilirubin ≤ 51 µmol/L, ALT/AST ≤ 3 times the upper limit of normal, creatinine ≤ 176.8 µmol/L
- Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography
- Pulse oxygen saturation of 92% or higher
- Estimated life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Pregnant or lactating women, or men and women with fertility willing to use effective contraception for at least 6 months after last cell infusion
- Voluntary participation with informed consent provided
You will not qualify if you...
- History of epilepsy or other central nervous system disorders
- Prolonged QT interval on electrocardiogram or severe heart diseases including severe arrhythmia
- Active infection with hepatitis B, C, or E virus
- Active infections that are not cured
- Prior use of any gene therapy products
- Recent anti-tumor therapies: systemic corticosteroids within 72 hours (except low dose physiologic replacement), small molecule targeted therapy within 72 hours, systemic chemotherapy within 2 weeks (except pretreatment), or radiotherapy within 4 weeks
- Proliferation rate less than 5 times response to CD3/CD28 co-stimulation signal
- Any condition judged by the investigator as unsuitable for participation
- Any situation that may increase risk or interfere with trial results as judged by researchers
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days after treatment
Participants receive CD5 CAR-T Cells therapy by intravenous infusion with dose escalation following the 3+3 dose escalation design across 3 dose levels.
1 infusion visit and multiple follow-up visits during the first 28 days
Duration - Up to 2 years after treatment
Participants are monitored for safety and effectiveness, including treatment-emergent adverse events, overall response, remission duration, progression-free survival, and overall survival.
Regular visits for up to 2 years after treatment
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
Y
Yongxian Hu, MD
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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