Actively Recruiting
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
Led by Sanofi · Updated on 2025-12-23
96
Participants Needed
16
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and activity of SAR448501/DR-0201, a bispecific antibody, in adults with relapsed or refractory B-cell non-Hodgkin lymphoma who have not responded to at least two prior standard therapies. This open-label phase 1 study aims to find the optimal biological dose by assessing pharmacokinetics, pharmacodynamics, clinical effects, and immune response in a group of patients with this condition. Participants will receive SAR448501 for up to 52 weeks in different dose levels, with multiple ascending doses studied across several cohorts. The study includes an initial screening period lasting up to 28 days, followed by the treatment period, then a safety follow-up of about 28 days. Afterward, participants enter a long-term follow-up phase every three months that continues until withdrawal of consent, death, or study closure. During the study, patients will undergo evaluations to monitor adverse events, disease response, and drug levels in the body. Assessments include measuring tumor response, survival outcomes, and immune reactions. Researchers will also collect biopsy samples before and during treatment when safely possible. Overall, each participant's involvement lasts about three years, including screening, treatment, safety monitoring, and long-term follow-up visits.
CONDITIONS
Brief 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 failed at least two prior standard life-prolonging therapies
- Adequate marrow reserve, kidney, and liver function
- Measurable disease with nodal lesions greater than 1.5 cm or extranodal lesions greater than 1.0 cm
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 12 weeks
- Use of highly effective contraception during the study and for 180 days after last dose for males and females of childbearing potential
- Negative serum pregnancy test within 7 days prior to first dose for females of childbearing potential
- Availability of tumor tissue block or recent biopsy samples from the past 12 months
- More than 60 days since prior CAR-T therapy at first dosing
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 certain follicular or mantle cell lymphoma cases with restrictions
- Prior solid organ transplant
- Autologous stem cell transplant within 100 days prior to dosing
- Active or history of autoimmune disease except well-controlled or remote cases
- Major surgery within 28 days before dosing
- Significant uncontrolled diseases that may affect study compliance
- History of CNS disease unless remote and without neurologic deficits
- QTcF interval greater than 480 msec
- Significant cardiovascular disease
- Recent anticancer systemic therapy within 4 weeks before study drug or 5 drug half-lives, except low-dose corticosteroids
- Known HIV, hepatitis B or C infection
- Active infection requiring treatment within 2 weeks before dosing
- Live vaccine administration within 4 weeks before study drug or expected during study
- Other invasive malignancies within 2 years except specified exceptions
- Blood clotting abnormalities or high risk of clotting events within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive the study drug SAR448501 in escalating doses for up to 52 weeks.
Visits occur according to dose escalation cohorts for up to 52 weeks
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)
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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