Actively Recruiting
A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Relapsed/ Refractory B-Cell Non-Hodgkin Lymphoma
Led by Sanofi · Updated on 2025-12-23
96
Participants Needed
16
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Relapsed/ Refractory B-Cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with relapsed or refractory B-cell non-Hodgkin lymphoma who have failed at least two prior life-prolonging standard therapies and have no recognized treatment options offering clinical benefit
- Adequate bone marrow, kidney, and liver function
- Measurable disease with at least one nodal lesion larger than 1.5 cm or one extranodal lesion larger than 1.0 cm
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Use of highly effective contraception during the study and for 180 days after last dose; females of childbearing potential must have a negative pregnancy test within 7 days before first dose
- Availability of tumor tissue block or recent biopsy within 12 months and willingness to provide baseline and at least one on-treatment biopsy unless unsafe
- Participants who had prior CAR-T therapy must be more than 60 days post-CAR-T on first dosing day
You will not qualify if you...
- Diagnosis of Burkitt's or Burkitt's-like lymphoma or lymphoplastic lymphoma
- Current central nervous system involvement by malignancy
- Prior allogeneic stem cell transplant except in follicular lymphoma or mantle cell lymphoma if transplant was less than 100 days before dosing or with graft versus host disease grade higher than 1
- Prior solid organ transplantation
- Autologous stem cell transplant within 100 days of dosing
- History of autoimmune disease such as myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis, vascular thrombosis with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis vasculitis, or glomerulonephritis unless well-controlled or remote
- Major surgery within 28 days prior to dosing
- Significant uncontrolled disease affecting study compliance
- Current or past central nervous system disease with residual neurological deficits
- Corrected QT interval (QTcF) over 480 msec
- Significant cardiovascular disease
- Receipt of any anticancer systemic therapy within 4 weeks prior to first drug administration except corticosteroids at ≤ 25 mg/day prednisone or equivalent
- Known infection with HIV, hepatitis B, or hepatitis C viruses
- Active infection requiring systemic antimicrobial treatment within 2 weeks prior to dosing
- Live attenuated vaccine within 4 weeks prior to first drug administration or planned during the study
- Another invasive cancer within past 2 years except certain low-risk cancers
- Coagulation abnormalities or hypercoagulation risks including recent hypercoagulation events or anticoagulation outside therapeutic range
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Investigational Site Number : 001-203
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
2
Investigational Site Number : 001-202
Townsville, Queensland, Australia, 4814
Actively Recruiting
3
Investigational Site Number : 001-205
Adelaide, South Australia, Australia, 5000
Actively Recruiting
4
Investigational Site Number : 001-204
Melbourne, Victoria, Australia, 3121
Actively Recruiting
5
Investigational Site Number : 001-201
Perth, Western Australia, Australia, 6009
Actively Recruiting
6
Investigational Site Number : 001-703
Kamenitz, Serbia, 21204
Active, Not Recruiting
7
Investigational Site Number : 001-601
Singapore, Singapore, 119074
Actively Recruiting
8
Investigational Site Number : 001-602
Singapore, Singapore, 308433
Actively Recruiting
9
Investigational Site Number : 001-401
Busan, South Korea, 48108
Actively Recruiting
10
Investigational Site Number : 001-403
Busan, South Korea, 49201
Actively Recruiting
11
Investigational Site Number : 001-404
Goyang-si, South Korea, 10408
Actively Recruiting
12
Investigational Site Number : 001-402
Seoul, South Korea, 03080
Actively Recruiting
13
Investigational Site Number : 001-405
Seoul, South Korea, 06351
Actively Recruiting
14
Investigational Site Number : 001-503
Changhua, Taiwan, 505
Actively Recruiting
15
Investigational Site Number : 001-502
Kaohsiung City, Taiwan, 83301
Actively Recruiting
16
Investigational Site Number : 001-501
Taipei, Taiwan, 10048
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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