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

Phase 1

Completed

• Conditions: on Hodgkin's Lymphoma

• Registration Number: JPRN-jRCT2080225077
• Lead Sponsor: Chugai Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 12

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>pharmacokinetics<br>other<br>other(DLT)<br>NCI CTCAE

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>pharmacokinetics<br>other<br>other (ADA)<br>Revised Response Criteria for Malignant Lymphoma