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A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Relapsed/ Refractory B-Cell Non-Hodgkin Lymphoma
Sponsor: Sanofi
Summary
This is an open-label, multiple ascending dose (MAD), phase 1 study in adult patients with relapsed or refractory (R/R) B cell non-Hodgkin lymphoma (B-NHL). The purpose of the study is to identify possible optimal biological dosage(s) by assessing safety, tolerability, pharmacokinetics (PK), pharmacodynamics, clinical activity and immunogenicity of SAR448501/DR-0201. The study duration per participant will be approximately 3 years, including a screening period of up to 28 days, a treatment period of 52 weeks, a safety follow-up period of approximately 28 days and a long-term follow-up period of every 3 months until withdrawal of consent, participant death or study closure, whichever is sooner.
Official title: A Multicenter, Multiple Expansion Cohort Phase 1 Study Evaluating the Safety and Activity of SAR448501/DR-0201 as Multiple Ascending Doses in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2024-07-08
Completion Date
2028-02-11
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
SAR448501
Bispecific antibody
Locations (16)
Investigational Site Number : 001-203
Camperdown, New South Wales, Australia
Investigational Site Number : 001-202
Townsville, Queensland, Australia
Investigational Site Number : 001-205
Adelaide, South Australia, Australia
Investigational Site Number : 001-204
Melbourne, Victoria, Australia
Investigational Site Number : 001-201
Perth, Western Australia, Australia
Investigational Site Number : 001-703
Kamenitz, Serbia
Investigational Site Number : 001-601
Singapore, Singapore
Investigational Site Number : 001-602
Singapore, Singapore
Investigational Site Number : 001-401
Busan, South Korea
Investigational Site Number : 001-403
Busan, South Korea
Investigational Site Number : 001-404
Goyang-si, South Korea
Investigational Site Number : 001-402
Seoul, South Korea
Investigational Site Number : 001-405
Seoul, South Korea
Investigational Site Number : 001-503
Changhua, Taiwan
Investigational Site Number : 001-502
Kaohsiung City, Taiwan
Investigational Site Number : 001-501
Taipei, Taiwan