L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma

Henan Cancer Hospital

Status and phase

Enrolling

Phase 1

Conditions

Relapsed/Refractory B-cell Lymphomas

Treatments

Drug: L218CAR19

Study type

Interventional

Funder types

Other

Identifiers

NCT06478381

HNSZLYYML09

Details and patient eligibility

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.

Enrollment

22 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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