L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma
A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of L218CAR19 in Patients With CD19 Positive Relapsed/Refractory B-cell Lymphomas
Henan Cancer Hospital
22 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria18
- 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
Interventions
L218CAR19 is intravenously administered at three dose levels.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06478381