L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma

NCT06478381 | Recruiting Phase 1

• 1 other identifier: HNSZLYYML09
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity (DLT)

  Occurrence of DLTs

  Up to 4 weeks

• Treatment-emergent adverse event (AE)

  Incidence of treatment-emergent AEs

  Up to 1 year

Secondary Outcomes (9)

• Quantification of L218CAR19 in peripheral blood

  Up to 1 year

• Time to reach Cmax (Tmax) of L218CAR19

  Up to 3 months

• Area under the curve (AUC) of L218CAR19

  Up to 3 months

• Clearance (CL) of L218CAR19

  Up to 3 months

• Immunogenic response to L218CAR19

  Up to 1 year

Study Arms (1)

Dose Escalation

EXPERIMENTAL

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

Drug: L218CAR19

Interventions

L218CAR19 DRUG

L218CAR19 is intravenously administered at three dose levels.

Dose Escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yanyan Liu

  Affiliated Cancer Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanyan Liu

CONTACT

86 037165587791; yyliu@zzu.edu.cn

Zheng Yan

CONTACT

86 13598097015; zlyyyanzheng3920@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 27, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

CN (1)