RecruitingPhase 1NCT06392477

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

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

Sponsor

Sanofi

Enrollment

96 participants

Start Date

Jul 8, 2024

Study Type

INTERVENTIONAL

Conditions

B-cell Non Hodgkin Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SAR448501 (also known as DR-0201) in people with a type of blood cancer called B-cell non-Hodgkin lymphoma (B-NHL) that has come back or stopped responding to at least 2 previous treatments. **You may be eligible if...** - You have B-NHL that has returned or is no longer responding to treatment - You have tried at least 2 prior treatments without success - Your cancer has at least one measurable tumor on imaging - You are in generally good health (ECOG score of 0 or 1) - You have at least 12 weeks of expected survival **You may NOT be eligible if...** - You are pregnant or breastfeeding (reliable contraception required) - You cannot provide a tumor tissue sample for analysis - Your liver, kidney, or bone marrow function does not meet required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSAR448501

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

View Full Details on ClinicalTrials.gov

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NCT06392477

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