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Monoclonal Antibodies

SAR442257 for Multiple Myeloma and Non-Hodgkin Lymphoma

Phase 1
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- must have received at least 3 prior lines of therapy including proteasome inhibitor (PI), immunomodulatory agent (IMiD), and anti-CD38 mAb;
- Histopathologically confirmed mycosis fungoides or Sézary syndrome (cutaneous T cell lymphoma [CTCL] stage IIB or greater according to the European Organization for Research and Treatment of Cancer/International Society for Cutaneous Lymphomas [EORTC-ISCL] consensus classification) at study entry with progressive, persistent, or recurrent disease who have no available remaining standard therapeutic options (ie, refractory) as determined by the Investigator.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (estimated 16 months)
Awards & highlights

Study Summary

This trial is testing a new drug for people with multiple myeloma or non-Hodgkin lymphoma who have not responded to other treatments. The goal is to find the highest dose of the drug that is safe and to see if it has any effect against the cancer.

Who is the study for?
Adults with relapsed and refractory multiple myeloma (RRMM) or non-Hodgkin lymphoma (RR-NHL), who have tried at least three prior therapies including specific agents, are not responding to certain treatments, and have measurable disease. They should be in stable condition with a life expectancy of at least 12 weeks, an ECOG performance status ≤2, no severe heart issues, and willing to use contraception.Check my eligibility
What is being tested?
The trial is testing SAR442257 as a single agent to find the highest dose patients can tolerate without severe side effects (MTD) for RRMM and RR-NHL. It will also determine the recommended Phase 2 dose (RP2D), study its safety profile, how it moves through the body (pharmacokinetics), potential immune response against it (immunogenicity), and initial signs of effectiveness against tumors.See study design
What are the potential side effects?
Specific side effects of SAR442257 aren't listed but generally may include reactions related to drug infusion, changes in blood counts or organ function tests indicating inflammation or damage. Side effects could range from mild symptoms like fatigue to more serious conditions requiring medical attention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had 3 types of treatments for my condition, including PI, IMiD, and anti-CD38.
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I have advanced cutaneous T cell lymphoma with no standard treatment options left.
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My condition is a type of T cell lymphoma.
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I have been diagnosed with diffuse large B-cell lymphoma.
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I can take care of myself but might not be able to do heavy physical work.
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I have a type of non-Hodgkin lymphoma with a tumor larger than 1.5 cm.
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I have been diagnosed with mantle cell lymphoma.
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My condition is marginal zone lymphoma.
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I have been diagnosed with diffuse large B-cell lymphoma.
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My multiple myeloma has not responded to or I cannot tolerate standard treatments.
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I can take care of myself and am up and about more than half of my waking hours.
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My condition is transformed follicular lymphoma.
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I am at least 18 years old or the legal adult age in my country.
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I have been diagnosed with follicular lymphoma.
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My multiple myeloma is measurable by medical tests.
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My condition is transformed follicular lymphoma.
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I have been diagnosed with lymphoplasmacytic lymphoma.
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My cancer is a specific type of immune system cancer linked to breast implants or affects my intestines, liver, or spleen.
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My heart pumps well and I don't have fluid around it, confirmed by an ECHO.
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I can provide a tissue sample from my lymphoma for testing.
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My condition is a type of T cell lymphoma.
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My condition worsened within 60 days after my last anti-CD38 antibody treatment.
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My lymphoma involves MYC, BCL2, or BCL6 rearrangement.
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I have advanced cutaneous T cell lymphoma with no standard treatment options left.
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I have been diagnosed with small lymphocytic lymphoma.
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My cancer is a specific type affecting the immune system and related to breast implants or certain organs.
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I have a type of non-Hodgkin lymphoma with a tumor larger than 1.5 cm.
Select...
I have had 3 types of treatments for my condition, including PI, IMiD, and anti-CD38 mAb.
Select...
My heart pumps well and I don't have fluid around it, confirmed by an ECHO.
Select...
My lymphoma involves MYC, BCL2, or BCL6 rearrangement.
Select...
My condition is a type of T-cell lymphoma.
Select...
I have relapsed or refractory multiple myeloma.
Select...
My condition is marginal zone lymphoma.
Select...
I have been diagnosed with lymphoplasmacytic lymphoma.
Select...
My multiple myeloma is measurable by medical tests.
Select...
My non-Hodgkin lymphoma has not responded to or cannot tolerate standard treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (estimated 16 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (estimated 16 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine maximum tolerated dose (MTD)
Determine recommended Phase 2 dose (RP2D)
Secondary outcome measures
Assessment of PK parameter: AUC0-τ
Assessment of PK parameter: Ctrough
Assessment of pharmacokinetic (PK) parameter: Cmax
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose escalationExperimental Treatment1 Intervention
SAR442257 will be given intravenously with lead-in doses (LID) in the first-week, followed by once weekly until week 4 (Cycle 1) and once weekly for each subsequent cycle(s).

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,158 Previous Clinical Trials
3,514,301 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,908 Total Patients Enrolled

Media Library

SAR442257 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04401020 — Phase 1
Cancer Research Study Groups: Dose escalation
Cancer Clinical Trial 2023: SAR442257 Highlights & Side Effects. Trial Name: NCT04401020 — Phase 1
SAR442257 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04401020 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What outcomes are researchers striving to attain with this experiment?

"Primarily, this clinical trial seeks to identify the maximum tolerated dose over a projected 4 month period. In addition to that objective, it will also assess pharmacokinetic parameters (AUC0-τ), overall response rate for RRMM according to IMWG 2016 criteria, and incidence of anti-drug antibodies (ADA) against SAR442257."

Answered by AI

What is the aggregate number of participants in this clinical research?

"This medical study seeks 57 participants that meet the given inclusion criteria. Patients can sign up at multiple facilities such as Mayo Clinic of Rochester-Site Number:8400003 in Rochester, Minnesota and City of Hope-Site Number:8400001 located in Duarte, California."

Answered by AI

Are there remaining vacancies in this trial that patients can apply to?

"Affirmative. Clinicaltrials.gov displays the information that this clinical trial, which was posted on July 24th 2020, is currently seeking applicants. The research requires 57 individuals to be recruited from 8 individual sites."

Answered by AI

What is the regulatory status of SAR442257?

"Preliminary evidence suggests SAR442257 is relatively safe, so it was given a score of 1. This being said, as this is only a Phase 1 trial there are limited data supporting safety and efficacy."

Answered by AI
~10 spots leftby Mar 2025