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Trial Title:
L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma
NCT ID:
NCT06478381
Condition:
Relapsed/Refractory B-cell Lymphomas
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
L218CAR19
Description:
L218CAR19 is intravenously administered at three dose levels.
Arm group label:
Dose Escalation
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18-75 years at the time of inclusion
- Written informed consent
- Patients with relapsed/refractory CD19 positive B-cell lymphomas, who have received
at least two lines of treatment
- With measurable disease
- ECOG PS 0-2 at protocol entry
- Estimated life expectancy of 3 months or longer
- Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count
≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow
involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN), or ≤3 x ULN if
elevation is due to hepatic involvement by lymphoma; Serum glutamic-oxaloacetic
transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or
≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤
1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%
- Women of childbearing potential must use safe anticonception (e.g. contraceptive
pills, intrauterine devices etc.) during the study and 6 months after the
administration of study drug; Male patients must use contraception for the duration
of the study and 6 months after the administration of study drug if his partner is
of childbearing potential
Exclusion Criteria:
- Patients with heart disease: atrial fibrillation; History of Class III or IV New
York Heart Association (NYHA) heart failure, myocardial infarction or other
significant cardiac disease within 12 months of screening; LVEF<50%; clinical
significant pericardial effusion; Long QT syndrome
- History of severe pulmonary function impairment
- With other uncontrolled malignancy
- With active bacterial, viral, or fungal infections
- WIth uncontrolled autoimmune disease or congential immunodeficiency
- HIV antibody positive patients
- Known severe hypersensitivity to biological product
- Patients with known active central nervous system (CNS) disease, including lymphoma
CNS involvement
- Patients with prior CAR-T therapy
- History of allogeneic stem cell transplantation
- History of autogeneic stem cell transplantation within 6 months of screening
- History of major surgery within 4 weeks of screening
- Patients receiving live (attenuated) vaccines within 6 weeks of screening
- Pregnant or lactating women, or pregnant plan within 12 months
- Involvement of cardiac tissue by lymphoma
- with emergency due to oncothlipsis
- Unwillingness or inability to comply with the protocol
- Deemed 'unfit' by the treating physician
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Cancer Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanyan Liu
Phone:
86-037165587791
Email:
yyliu@zzu.edu.cn
Contact backup:
Last name:
Zheng Yan
Phone:
86+13598097015
Email:
zlyyyanzheng3920@zzu.edu.cn
Start date:
June 1, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06478381
