Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Toripalimab for Patients With Recurrent Malignant Lymphoma

NCT ID: NCT03316144

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-12
• Study Completion Date: 2019-12-30

Brief Summary

The primary objective is to assess the safety and tolerability of JS-001 in subjects with recurrent malignant lymphoma, and to evaluate its preliminary efficacy.

The secondary objectives are to: 1) characterize the single-dose and multi-dose pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3) assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate biomarkers associated with the efficacy of JS-001.

Conditions

Malignant Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 mg/kg Toripalimab

humanized anti-PD-1 monoclonal antibody is to be injected intravenously 1mg/kg Q2w until disease progresses or unacceptable tolerability occurs

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: BIOLOGICAL

Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS001. Subjects will be assigned to a dose schedule in the order of study entry.

3 mg/kg Toripalimab

humanized anti-PD-1 monoclonal antibody is to be injected intravenously 3mg/kg Q2w until disease progresses or unacceptable tolerability occurs

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: BIOLOGICAL

Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS001. Subjects will be assigned to a dose schedule in the order of study entry.

10 mg/kg Toripalimab

humanized anti-PD-1 monoclonal antibody is to be injected intravenously 10mg/kg Q2w until disease progresses or unacceptable tolerability occurs

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: BIOLOGICAL

Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS001. Subjects will be assigned to a dose schedule in the order of study entry.

Interventions

Toripalimab

Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS001. Subjects will be assigned to a dose schedule in the order of study entry.

Intervention Type: BIOLOGICAL

Other Intervention Names

JS001, TAB001

Eligibility Criteria

Inclusion Criteria

• Willing to sign Informed Consent;
• Re-entry into the study is allowed with a second informed consent;
• Willing to provide blood sample for biomarker analysis(mandatory). The tissue sample is optional;
• A diagnosis of an advanced malignant tumor confirmed by histology or cytology (including typical Hodgkin's lymphoma and B cell source non-hodgkin's lymphoma);
• No standard of care for the patient;
• At least 1 measurable lesion;
• Aged 18-65 years;
• Anticipated life expectancy of at least 6 months;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• At least 4 weeks elapsed since receiving systemic chemotherapy;
• At least 4 weeks elapsed since receiving definite radiotherapy;
• At least 2 weeks since the last dose of systemic steroid therapy (>10 mg/day prednisone or equivalent);
• At least 4 weeks since receiving anti-cancer biotherapy;
• Recovered from previous treatment related adverse reaction; willing to use an acceptable contraceptive method;
• A negative pregnancy test for female subjects of childbearing potential;

Exclusion Criteria

• Active central nervous system (CNS) metastases and/or carcinomatous meningitis;
• Known history of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 2 years, or underwent successful definitive resection of basal or squamous cell carcinoma of the skin, or in situ cervical cancer;
• Active, known or suspected autoimmune disease.Autoimmune diseases caused by lymphoma are not included in this list;
• Patients who have had car-T cell therapy
• Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibodies;
• Significant medical disease;
• Active infection;
• Active tuberculosis or history of tuberculosis with one year;
• Infection of Human immunodeficiency virus (HIV);
• A complication requiring immune-suppression;
• Received a live vaccine within 4 weeks prior to first dose of study drug pleural or abdominal effusion with symptoms;
• Drug or alcohol abuse (for subjects in the pharmacokinetic cohorts) ; evidence of interstitial lung disease;
• Active hepatitis B or C, or with significant risk of hepatitis reactivation;
• Known immediate or delayed hypersensitivity reaction or idiosyncrasy to monoclonal antibodies or drugs chemically related to the study drug. History of serious hypersensitivity reaction or serious hepatotoxicity related to any drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junyuan Qi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Blood Diseases Hospital, Chinese Academy of Medical Sciences

Locations

Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

Junshi-JS001-011

Identifier Type: -

Identifier Source: org_study_id