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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