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Study identifier: NCT06392477 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Relapsed/ Refractory B-Cell Non-Hodgkin Lymphoma

Condition: B-cell Non Hodgkin Lymphoma  ·  Sponsor: Sanofi

PhasePhase 1
Planned participants96
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Trial Transparency email recommended (Toll free for US & Canada)  ·  800-633-1610  ·  Contact-US@sanofi.com

Always discuss trial participation with your own doctor first.

Locations (16)

Investigational Site Number : 001-203Camperdown, New South Wales, AustraliaRecruiting
Investigational Site Number : 001-202Townsville, Queensland, AustraliaRecruiting
Investigational Site Number : 001-205Adelaide, South Australia, AustraliaRecruiting
Investigational Site Number : 001-204Melbourne, Victoria, AustraliaRecruiting
Investigational Site Number : 001-201Perth, Western Australia, AustraliaRecruiting
Investigational Site Number : 001-703Kamenitz, SerbiaActive Not Recruiting
Investigational Site Number : 001-601Singapore, SingaporeRecruiting
Investigational Site Number : 001-602Singapore, SingaporeRecruiting
Investigational Site Number : 001-401Busan, South KoreaRecruiting
Investigational Site Number : 001-403Busan, South KoreaRecruiting
Investigational Site Number : 001-404Goyang-si, South KoreaRecruiting
Investigational Site Number : 001-402Seoul, South KoreaRecruiting

+ 4 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06392477