Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab (TJ011133) With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma

What's the purpose of this trial?

The purpose of this study is to assess how safe lemzoparlimab (TJ01133) is and how lemzoparlimab (TJ01133) moves through the body of adult participants with MM when given with or without dexamethasone, and in combination with other anti-myeloma regimens. Adverse events and change in disease activity will be assessed.

This is an upcoming trial that has not yet started accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
    • Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma.
    • Refractory defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy, or progresses within 60 days of last therapy.
  • Measurable disease within 28 days prior to enrollment.
  • Arm A - Lemzoparlimab (TJ011133) with or without Dexamethasone
    • For Both Escalation and Expansion Phase, participant must have refractory to 3 prior lines of treatment including standard of care (SOC).
  • Arm B - Lemzoparlimab (TJ011133) + Pomalidomide-Dexamethasone
    • For Escalation Phase - Participant must have received at least 2 prior lines of therapy, including lenalidomide and a Proteasome inhibitor (PI).
    • For Expansion Phase - Participant must have received at least 1 prior line of therapy, including lenalidomide and a Proteasome inhibitor (PI).
  • Arm C - Lemzoparlimab (TJ011133) + Carfilzomib-Dexamethasone
    • For Both Escalation and Expansion Phase - Participant must have received at least 1 prior line of therapy.
  • Arm D - Lemzoparlimab (TJ011133) + Daratumumab-Dexamethasone
    • For Escalation Phase: Participant must have received at least 3 prior lines of therapy including a PI and an Immunomodulatory imide drug (IMiD).
    • For Expansion Phase: Participant must have received at least 1 prior line of therapy including a PI and an IMiD.

Exclusion Criteria:

  • Arm B - Lemzoparlimab (TJ011133) + Pomalidomide-Dexamethasone
    • For Both Escalation and Expansion Phase participant must have had no prior treatment with pomalidomide.
  • Arm C - Lemzoparlimab (TJ011133) + Carfilzomib-Dexamethasone
    • For Both Escalation and Expansion Phase - prior treatment with carfilzomib.
  • Arm D - Lemzoparlimab (TJ011133) + Daratumumab-Dexamethasone
    • For Both Escalation and Expansion Phase - prior treatment with daratumumab or other anti-CD38 therapy.

Additional Trial Information

Phase 1

Enrollment: 163 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

University of Arizona Comprehensive Cancer Center

Tucson, AZ

Not Yet Accepting

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting

Kentucky

Norton Cancer Institute St. Matthews Campus

Louisville, KY

Not Yet Accepting

Louisiana

Tulane Cancer Center Tulane University School of Medicine

New Orleans, LA

Not Yet Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Not Yet Accepting

Michigan

University of Michigan Comprehensive Cancer Center

Ann Arbor, MI

Not Yet Accepting

Henry Ford Hospital

Detroit, MI

Not Yet Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Not Yet Accepting

New Jersey

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Not Yet Accepting

New York

North Carolina

Wake Forest Baptist Comprehensive Cancer Center Wake Forest School of Medicine

Winston-Salem, NC

Not Yet Accepting

Duke Cancer Center Duke University Medical Center

Durham, NC

Not Yet Accepting

Pennsylvania

University of Pennsylvania Presbyterian Medical Center

Philadelphia, PA

Not Yet Accepting

Texas

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Not Yet Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Not Yet Accepting

Virginia

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Not Yet Accepting

Washington

University of Washington School of Medicine

Seattle, WA

Not Yet Accepting

Wisconsin

Aurora Sinai Medical Center

Milwaukee, WI

Not Yet Accepting
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