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

NCT06392477 | Recruiting Phase 1

• 3 other identifiers: DR-0201-ONC-001DR0201ONC001U1111-1328-7660
• Study Type: interventional
• Target: 96
• Locations: 5 countries
• Sites: 16

Brief 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.

Conditions

B-cell Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse event (TEAE)

  Baseline to 28 days post last dose

• Potential pharmacologically optimized dose/regimen(s) of SAR448501 / DR-0201 in participants with R/R B-NHL

  Potential pharmacologically optimized dose/regimen(s) of SAR448501/DR-0201 in participants with R/R B-NHL as determined using an integrated assessment of efficacy, safety, pharmacokinetic (PK)/pharmacodynamic (PD), and exposure-response relationships

  Cycle 1 (Day 1 to Day 28)

Secondary Outcomes (12)

• Response rate assessed for CLL

  Baseline until disease progression (up to the end of treatment at Week 52)

• Response rate assessed for all other B-NHL lymphomas

  Baseline until disease progression (up to the end of treatment at Week 52)

• Duration of response/remission (DOR)

  Baseline until disease progression (up to the end of treatment at Week 52)

• Complete response/remission rate (CRR)

  Baseline until the end of treatment (Week 52)

• Time to response (TTR in months)

  Baseline until the end of treatment (Week 52)

Study Arms (1)

SAR448501 dose escalation

EXPERIMENTAL

SAR448501 will be administered for up to 52 weeks. Different cohorts with up to 8 dose levels will be included.

Drug: SAR448501

Interventions

SAR448501 DRUG

Bispecific antibody

Also known as: DR-0201

SAR448501 dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with R/R B-NHL which has failed at least 2 prior lines available life-prolonging standard therapy and without treatment options that are recognized to offer clinical benefit.
• Adequate marrow reserve, renal function, and hepatic function.
• Measurable disease defined as ≥ 1 bi-dimensionally measurable nodal lesion of \> 1.5 cm in the longest dimension for participants with fluorodeoxyglucose (FDG)-avid disease for subtypes with nodular disease or at least one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest dimension.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Life expectancy of ≥ 12 weeks.
• Use of a highly effective contraceptive measure for all males and all females of childbearing potential during study through 180 days post last dose; Females of childbearing potential need to have a negative serum pregnancy test within 7 days prior to first dose.
• Tumor tissue block or 3 to 5 unstained slides from lymph node or other relevant biopsy collected in the past 12 months. Participants must be willing to provide a baseline and at least 1 on-treatment biopsy, unless not safely accessible.
• Participants who have received prior CAR-T therapy must be \>60 days post CAR-T at day of first dosing.

You may not qualify if:

• Burkitt's or Burkitt's like lymphoma or lymphoplastic lymphoma.
• Current history of central nervous system (CNS) involvement by malignancy.
• Prior allogeneic stem cell transplantation except for those with follicular lymphoma (FL) and mantle cell lymphoma (MCL), who are excluded if transplant occurred less than 100 days prior to dosing or if they exhibit grade \> 1 graft versus host disease.
• Prior solid organ transplantation.
• Autologous stem cell transplantation ≤ 100 days prior to dosing.
• History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjorgen's syndrome, Guillain-Barre-syndrome, multiple sclerosis vasculitis, or glomerulonephritis (participants with a remote history of, or well-controlled autoimmune disease, may be eligible).
• Major surgery in the last 28 days prior to dosing.
• Evidence of significant, uncontrolled concomitant disease that could affect compliance with study.
• Current or past history of CNS disease (participants with remote history of non-lymphoma CNS disease and with no residual neurologic deficits may be eligible to enroll).
• QT interval corrected by Fridericia's formula (QTcF) \> 480 msec.
• Significant cardiovascular disease.
• Received any anticancer systemic therapy within 4 weeks prior to first drug administration or 5 half-lives of the drug, whatever is shorter. Treatment with corticosteroid ≤ 25 mg/day prednisone or equivalent is allowed. Inhaled and topical steroids are allowed.
• Known infection with HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).
• Active infection at baseline requiring systemic treatment with antimicrobial, antifungal, or antiviral agents in the 2 weeks prior to dosing.
• Administration of a live, attenuated vaccine within 4 weeks prior to first drug administration or anticipation that such vaccine administration would be necessary during the course of the study.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (16)

Investigational Site Number : 001-203

Camperdown, New South Wales, 2050, Australia

RECRUITING

Investigational Site Number : 001-202

Townsville, Queensland, 4814, Australia

RECRUITING

Investigational Site Number : 001-205

Adelaide, South Australia, 5000, Australia

RECRUITING

Investigational Site Number : 001-204

Melbourne, Victoria, 3121, Australia

RECRUITING

Investigational Site Number : 001-201

Perth, Western Australia, 6009, Australia

RECRUITING

Investigational Site Number : 001-703

Kamenitz, 21204, Serbia

ACTIVE NOT RECRUITING

Investigational Site Number : 001-601

Singapore, 119074, Singapore

RECRUITING

Investigational Site Number : 001-602

Singapore, 308433, Singapore

RECRUITING

Investigational Site Number : 001-401

Busan, 48108, South Korea

RECRUITING

Investigational Site Number : 001-403

Busan, 49201, South Korea

RECRUITING

Investigational Site Number : 001-404

Goyang-si, 10408, South Korea

RECRUITING

Investigational Site Number : 001-402

Seoul, 03080, South Korea

RECRUITING

Investigational Site Number : 001-405

Seoul, 06351, South Korea

RECRUITING

Investigational Site Number : 001-503

Changhua, 505, Taiwan

RECRUITING

Investigational Site Number : 001-502

Kaohsiung City, 83301, Taiwan

RECRUITING

Investigational Site Number : 001-501

Taipei, 10048, Taiwan

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): January 21, 2028
• Study Completion (Estimated): February 11, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

AU (5); SG (2); TW (3); KR (5); SE (1)