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RECRUITING
NCT06392477
PHASE1

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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

Interventions

DRUG

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