A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Relapsed/ Refractory B-Cell Non-Hodgkin Lymphoma
NCT ID: NCT06392477
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
96 participants
INTERVENTIONAL
2024-07-08
2028-02-11
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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SAR448501 dose escalation
SAR448501 will be administered for up to 52 weeks. Different cohorts with up to 8 dose levels will be included.
SAR448501
Bispecific antibody
Interventions
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SAR448501
Bispecific antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Another invasive malignancy in the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin, asymptomatic prostate cancer requiring only hormonal therapy and with normal prostate-specific antigen for \> 1 year, and tumors deemed by the investigator to be of low likelihood for recurrence).
* Prothrombin time/international normalized ratio (INR) and activated partial thromboplastin time or partial thromboplastin time (aPTT/PTT) \> 1.3 × ULN or outside the therapeutic range of the local laboratory if receiving therapeutic anticoagulation that would affect the prothrombin time/INR, participants with a history of a hypercoagulation event within 6 months, or participants who have known hypercoagulation risk factors will be excluded.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Other Identifiers
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DR-0201-ONC-001
Identifier Type: -
Identifier Source: org_study_id
DR0201ONC001
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1328-7660
Identifier Type: REGISTRY
Identifier Source: secondary_id