L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma

NCT ID: NCT06478381

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-06-30

Brief 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.

Conditions

Relapsed/Refractory B-cell Lymphomas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation

L218CAR19 is administered via infusion with ascending dose levels to determine the maximum tolerated dose (MTD)

Group Type: EXPERIMENTAL

L218CAR19

Intervention Type: DRUG

L218CAR19 is intravenously administered at three dose levels.

Interventions

L218CAR19

L218CAR19 is intravenously administered at three dose levels.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yanyan Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanyan Liu

Role: PRINCIPAL_INVESTIGATOR

Affiliated Cancer Hospital of Zhengzhou University

Locations

Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanyan Liu

Role: CONTACT

yyliu@zzu.edu.cn

86 037165587791

Zheng Yan

Role: CONTACT

zlyyyanzheng3920@zzu.edu.cn

86 13598097015

Facility Contacts

Yanyan Liu

Role: primary

yyliu@zzu.edu.cn

86-037165587791

Zheng Yan

Role: backup

zlyyyanzheng3920@zzu.edu.cn

86+13598097015

Other Identifiers

HNSZLYYML09

Identifier Type: -

Identifier Source: org_study_id