Actively Recruiting
L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma
Led by Henan Cancer Hospital · Updated on 2024-06-27
22
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
L218CAR19 is a kind of chimeric antigen receptor T-cell immunotherapy targeting CD19 on B cells. The goal of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of L218CAR19 in patients with B-cell lymphomas who have received at least two lines of systemic treatment.
CONDITIONS
Official Title
L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years at the time of inclusion
- Written informed consent
- Patients with relapsed or refractory CD19-positive B-cell lymphomas who have received at least two lines of treatment
- Measurable disease present
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 at study entry
- Estimated life expectancy of 3 months or longer
- Hemoglobin level of at least 8 g/dL (5 mmol/l)
- Platelet count of at least 75 x 10^9/L (or at least 50 x 10^9/L if bone marrow involvement is documented)
- Absolute neutrophil count of at least 1.0 x 10^9/L
- Serum bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), or up to 3 times ULN if elevated due to lymphoma involvement of the liver
- Serum AST and/or ALT less than or equal to 2.5 times ULN, or up to 5 times ULN if elevated due to lymphoma involvement of the liver
- Serum creatinine less than or equal to 1.5 times ULN
- Left ventricular ejection fraction (LVEF) of at least 50%
- Women of childbearing potential must use safe contraception during the study and for 6 months after treatment
- Male patients must use contraception during the study and for 6 months after treatment if their partner is of childbearing potential
You will not qualify if you...
- History of heart disease including atrial fibrillation, Class III or IV NYHA heart failure, myocardial infarction, or significant cardiac disease within 12 months before screening
- Left ventricular ejection fraction (LVEF) below 50%
- Clinically significant pericardial effusion
- Long QT syndrome
- Severe pulmonary function impairment
- Presence of other uncontrolled cancers
- Active bacterial, viral, or fungal infections
- Uncontrolled autoimmune disease or congenital immunodeficiency
- HIV antibody positive status
- Known severe hypersensitivity to biological products
- Active central nervous system (CNS) disease including lymphoma involvement
- Prior CAR-T therapy
- History of allogeneic stem cell transplantation
- Autologous stem cell transplantation within 6 months before screening
- Major surgery within 4 weeks before screening
- Receipt of live vaccines within 6 weeks before screening
- Pregnant or breastfeeding women or plans to become pregnant within 12 months
- Lymphoma involvement of cardiac tissue
- Emergency due to oncothlipsis
- Unwillingness or inability to comply with the study protocol
- Deemed unfit by the treating physician
AI-Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450008
Actively Recruiting
Research Team
Y
Yanyan Liu
CONTACT
Z
Zheng Yan
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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