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

Stopped early · Phase 1

Conditions studied: Multiple Myeloma, Multiple Myeloma in Relapse, Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT03266692

Run by

Cogent Biosciences, Inc.

People needed

15

Starts

2018-02-22

Expected to finish

2019-10-01

Last updated by the study team

2020-03-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Indiana Blood and Marrow Transplantation — Indianapolis, Indiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Baylor Scott & White — Dallas, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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