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B-cell Non Hodgkin LymphomaPhase 1NCT06392477

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

A Phase 1 study testing SAR448501 in people with B-cell Non Hodgkin Lymphoma, run by Sanofi at 16 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Non Hodgkin Lymphoma
What is being tested?
SAR448501
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
16 sitesin 5 countries
Study dates
8 Jul 2024to 11 Feb 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 18Show fewer
  • 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.

Trial locations and contacts

16 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

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

800-633-1610 ext. option 6

Contact-US@sanofi.com

16 sites in 5 countries

Australia5 sites, 5 recruiting

  • Investigational Site Number : 001-205

    Adelaide, South Australia, 5000

    Recruiting

  • Investigational Site Number : 001-203

    Camperdown, New South Wales, 2050

    Recruiting

  • Investigational Site Number : 001-204

    Melbourne, Victoria, 3121

    Recruiting

  • Investigational Site Number : 001-201

    Perth, Western Australia, 6009

    Recruiting

  • Investigational Site Number : 001-202

    Townsville, Queensland, 4814

    Recruiting

Other trials in Australia

South Korea5 sites, 5 recruiting

  • Investigational Site Number : 001-401

    Busan, 48108

    Recruiting

  • Investigational Site Number : 001-403

    Busan, 49201

    Recruiting

  • Investigational Site Number : 001-404

    Goyang-si, 10408

    Recruiting

  • Investigational Site Number : 001-402

    Seoul, 03080

    Recruiting

  • Investigational Site Number : 001-405

    Seoul, 06351

    Recruiting

Other trials in South Korea

Taiwan3 sites, 3 recruiting

  • Investigational Site Number : 001-503

    Changhua, 505

    Recruiting

  • Investigational Site Number : 001-502

    Kaohsiung City, 83301

    Recruiting

  • Investigational Site Number : 001-501

    Taipei, 10048

    Recruiting

Other trials in Taiwan

Singapore2 sites, 2 recruiting

  • Investigational Site Number : 001-601

    Singapore, 119074

    Recruiting

  • Investigational Site Number : 001-602

    Singapore, 308433

    Recruiting

Other trials in Singapore

Serbia1 site

  • Investigational Site Number : 001-703

    Kamenitz, 21204

    Active, not recruiting

Other trials in Serbia

About this study

Official title: 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

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.

Being tested
SAR448501
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR448501Drug

    Also called DR-0201

    Bispecific antibody

Study groups in NCT06392477
Study groupRoleWhat they receive
SAR448501 dose escalationExperimentalSAR448501 will be administered for up to 52 weeks. Different cohorts with up to 8 dose levels will be included.
Receives: Drug: SAR448501

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse event (TEAE)

    Measured: Baseline to 28 days post last dose

  2. 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

    Measured: Cycle 1 (Day 1 to Day 28)

Secondary outcomes (12)

  1. Response rate assessed for CLL

    Response rate assessed for chronic lymphocytic leukemia (CLL) by International Workshop on Chronic Lymphocytic Leukemia (iwCLL). The iwCLL response is based on the overall physical examination and evaluation of blood and bone marrow: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).

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

  2. Response rate assessed for all other B-NHL lymphomas

    Response rate assessed for all other B-NHL lymphomas by Lugano response criteria. The Lugano response is based on the overall radiographic response: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), not evaluable (NE) and not available (NA).

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

  3. Duration of response/remission (DOR)

    DOR is defined as the time between first disease response and date of disease progression or death due to any cause, whichever occurs first.

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

  4. Complete response/remission rate (CRR)

    Proportion of participants who have a complete response/remission, based on the disease assessments by the Investigator.

    Measured: Baseline until the end of treatment (Week 52)

  5. Time to response (TTR in months)

    TRR is defined as the time between the first administration of investigational medicinal product (IMP) at Cycle 1 Day 1 (C1D1) until first documented disease response.

    Measured: Baseline until the end of treatment (Week 52)

  6. Progression-free survival (PFS)

    PFS is defined as the time between the first administration of IMP at C1D1 and date of disease progression or death due to any case, whichever occurs first.

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

  7. Overall survival (OS)

    OS is defined as the time between the first administration of IMP (C1D1) and death due to any cause.

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

  8. Assessment of pharmacokinetic (PK) parameters: AUC0-t

    Area under the plasma concentration versus time curve calculated using the trapezoidal method during a dosing interval (t)

    Measured: Baseline to 28 days post last dose

  9. Assessment of PK parameters: Cmax

    Maximum observed plasma concentration

    Measured: Baseline to 28 days post last dose

  10. Assessment of PK parameters: Tmax

    Time to reach Cmax

    Measured: Baseline to 28 days post last dose

  11. Assessment of PK parameters: terminal elimination half-life

    Time for the concentration to decrease in half

    Measured: Baseline to 28 days post last dose

  12. Incidence of anti-drug antibodies (ADAs)

    Incidence of anti-drug antibodies (ADAs) against SAR448501/DR-0201

    Measured: Baseline to 28 days post last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start8 Jul 2024
  3. Primary completion21 Jan 2028 (estimated)
  4. Study completion11 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06392477
Sponsor's protocol ID
DR-0201-ONC-001
Other IDs
DR0201ONC001, U1111-1328-7660
Status last verified
Dec 2025
First submitted
23 Apr 2024
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR448501 in people with B-cell Non Hodgkin Lymphoma, run by Sanofi at 16 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Australia, South Korea, Taiwan, Singapore, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse event (TEAE) (time frame: Baseline to 28 days post last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06392477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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