Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma

Overview

This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory Multiple Myeloma.

SparkCures ID 904
Trial Phase Phase 1
Enrollment 30 Patients
Treatments
Trial Sponsors
  • Unum Therapeutics Inc.
Trial Collaborators
  • Seattle Genetics
NCT Identifier

NCT03266692

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Signed written informed consent obtained prior to study procedures
  • Histologically- or cytologically-confirmed relapsed or refractory multiple myeloma (MM) with measurable disease
  • Must have received at least 3 prior lines of therapy to include treatment with a proteasome inhibitor (eg, bortezomib, carfilzomib, or ixazomib) and an immunomodulatory agent (eg, lenalidomide, pomalidomide) unless double-refractory to both; and a hematopoietic stem cell transplant (HSCT), for those subjects considered HSCT-eligible.
  • Quantitative serum IgG levels for subjects with IgG MM must not exceed the institutional upper limit of normal (ULN)
  • ECOG 0 or 1
  • Life expectancy of at least 6 months
  • Absolute neutrophil (ANC) count greater than 1000/ µL
  • Platelet count greater than 50,000/µL
  • Estimated GFR >30mL/min/1.73m2

Exclusion Criteria:

  • Known active central nervous system (CNS) involvement by MM
  • Systemic rheumatic or autoimmune diseases or acute or chronic infections
  • Uncontrolled thromboembolic events or recent severe hemorrhage
  • Subjects who are currently using more than 5mg/day of prednisone (or an equivalent glucocorticoid exceeding physiologic replacement levels)
  • Prior treatment as follows:
    • T cell-directed antibody therapy (eg. Alemtuzumab, anti-thymocyte globulin) within 6 months of enrollment
    • Any prior myeloma-directed therapy including cytotoxic chemotherapy, biologic therapy, or radiotherapy within 2 weeks of enrollment
    • Any mAb or other protein therapeutic containing Fc-domains within 4 weeks of enrollment
    • Experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
    • Prior BCMA-directed investigational agents at any time
    • Prior cell or gene therapy, excluding transfers of genetically unmodified autologous cells (eg. Hematopoietic stem cell transplantation), at any time; or prior allogeneic HSCT at any time
  • Pregnant or breastfeeding

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified Medical College of Wisconsin - Froedtert Hospital

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Mayo Clinic (Jacksonville)

Jacksonville, FL

Blood and Marrow Transplantation - Franciscan Health

Indianapolis, IN

Tufts Medical Center Cancer Center

Boston, MA

Arizona
Florida
Mayo Clinic (Jacksonville)

Jacksonville, FL

Indiana
Blood and Marrow Transplantation - Franciscan Health

Indianapolis, IN

Massachusetts
Tufts Medical Center Cancer Center

Boston, MA

Ohio
Texas
Wisconsin
Verified Medical College of Wisconsin - Froedtert Hospital

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Resources

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