A PHASE I STUDY OF RO7082859 IN PATIENTS WITH B-CELL NON-HODGKIN'S LYMPHOMA

JRCT ID: jRCT2080225077

Registered date:18/02/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Non Hodgkin's Lymphoma
• Date of first enrollment: 02/03/2020
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : RO7082859
INN of investigational material : glofitamab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 2.5 mg or more weekly or 3 weekly
Generic name etc : obinutuzumab
INN of investigational material : obinutuzumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 1000 mg as an IV infusion
Generic name etc : Tocilizumab
INN of investigational material : Tocilizumab
Therapeutic category code : 639 Other biological preparations
Dosage and Administration for Investigational material : 8mg/kg as an IV infusion

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

safety
pharmacokinetics
other
other(DLT)
NCI CTCAE

Secondary Outcome

safety
efficacy
pharmacokinetics
other
other (ADA)
Revised Response Criteria for Malignant Lymphoma

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- CD20 positive B cell NHL that is recurrent or refractory to standard therapy or for which no standard therapy exists.
- Pathologically confirmed B cell NHL.
- ECOG PS of 0 or 1.
- Life expectancy =>12 weeks from the date of enrollment.
- Major organ function meets all criteria.

Exclude criteria

- Pregnant or lactating woman.
- Current or previous autoimmune disease.
- Positive test result for human immunodeficiency virus antibody, hepatitis B surface antigen, HBs antibody, hepatitis B core antibody, or hepatitis C virus antibody.
- Current or previous clinically significant liver disease.
- Current central nervous system lymphoma, metastases to the CNS, or meningeal metastases.
- History of previous therapy with allogenic hematopoietic stem cell transplantation or solid organ transplantation.
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or fusion proteins.

Related Information

• Primary Sponsor: Chugai Pharmaceutical Co., Ltd.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): JapicCTI-205172