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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

- 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.

Patients with RR-NHL subtype T cell lymphoma (TCL) including the following subtype of disease:

Must not have

Has active autoimmune disease including autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, inflammatory bowel syndrome, pneumonitis or any chronic condition requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily.

Amyloidosis, chronic lymphocytic leukemia and prolymphocytic leukemia. Known central nervous system (CNS) involvement by myeloma, lymphoma or other CNS disease such as neurodegenerative condition or CNS movement disorder.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion (estimated 16 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests SAR442257, a new drug, in patients with hard-to-treat multiple myeloma and non-Hodgkin lymphoma. It aims to find the highest safe dose and see if the drug can shrink tumors.

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.

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.

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 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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My condition is marginal zone lymphoma.

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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 have been diagnosed with lymphoplasmacytic lymphoma.

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My lymphoma involves MYC, BCL2, or BCL6 rearrangement.

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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.

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I have had 3 types of treatments for my condition, including PI, IMiD, and anti-CD38 mAb.

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My heart pumps well and I don't have fluid around it, confirmed by an ECHO.

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My multiple myeloma is measurable by medical tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune disease that needs more than 10 mg of prednisone daily.

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I have a condition affecting my brain or nervous system, such as amyloidosis, leukemia, or a movement disorder.

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I have serious heart issues, including recent heart attack or uncontrolled blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion (estimated 16 months)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine maximum tolerated dose (MTD)

Determine recommended Phase 2 dose (RP2D)

Secondary study objectives

Assessment of PK parameter: AUC0-τ

Assessment of PK parameter: Ctrough

Assessment of pharmacokinetic (PK) parameter: Cmax

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 16Eligibility criteria met