Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma

NCT06630806 · View on ClinicalTrials.gov ↗

Study Summary

This is a first-in-human study of SAR446523 conducted in patients with RRMM. The study consists of two parts: Dose escalation (Part A): In this part, up to 6 dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part. Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming from Part A), to determine the optimal dose as the recommended phase 2 dose (RP2D) of SAR446523.

Interventions

  • DRUG SAR446523

Study Locations (18)

Other

  • Investigational Site Number : 2500002 — Lille
  • Investigational Site Number : 2500001 — Nantes
  • Investigational Site Number : 3760004 — Haifa
  • Investigational Site Number : 3760002 — Jerusalem
  • Investigational Site Number : 7240001 — Madrid

Quebec

  • Investigational Site Number : 1240001 — Montreal
  • Investigational Site Number : 1240002 — Sherbrooke

Arizona

  • Mayo Clinic in Arizona - Phoenix- Site Number : 8400005 — Phoenix

Florida

  • Mayo Clinic in Florida- Site Number : 8400003 — Jacksonville

Minnesota

  • Mayo Clinic in Rochester - Minnesota- Site Number : 8400004 — Rochester

New Jersey

  • Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001 — Hackensack

Pennsylvania

  • Thomas Jefferson University Hospital- Site Number : 8400002 — Philadelphia

New South Wales

  • Investigational Site Number : 0360001 — Wollongong

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2024-10-30
Est. Completion 2029-05-14
Phase Phase 1

Sponsor

Sanofi

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06630806

The ClinicalTrials.gov registry entry for NCT06630806 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Plasma Cell Myeloma Refractory appearing as the primary indexed condition, and to 1 intervention — of which SAR446523 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06630806 reports 18 study locations spanning 13 distinct geographic areas — top geographies include Other, Quebec, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06630806 about?

NCT06630806 is a clinical study titled "A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma". This is a first-in-human study of SAR446523 conducted in patients with RRMM. The study consists of two parts: Dose escalation (Part A): In this part, up to 6 dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommen...

What is the current status of trial NCT06630806?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2024-10-30. Estimated completion is 2029-05-14.

What conditions does trial NCT06630806 study?

This clinical trial studies the following conditions: Plasma Cell Myeloma Refractory. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06630806?

The interventions under investigation include: SAR446523 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06630806?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06630806 being conducted?

This trial has 18 study locations across Arizona, Florida, Minnesota, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial