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


Title A Phase 1 Study of ACTR087, an Autologous T Cell Product, in Combination with SEA-BCM, a Monoclonal Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma 
Therapeutic Area Multiple Myeloma
Principal Investigator Cindy Varga, MD
Min Age 18 Years
Max Age 80 Years
Gender All
Contact Natasha Khona
617-636-2683
More Information https://www.clinicaltrials.gov/ct2/show/NCT03266692

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. 

Study Details

Inclusion Criteria

  • 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
  • Life expectancy of at least 6 months

Exclusion Criteria

  • Known active central nervous system (CNS) involvement by MM
  • Systemic rheumatic or autoimmune diseases or acute or chronic infections
  • Subjects who are currently using more than 5mg/day of prednisone (or an equivalent glucocorticoid exceeding physiologic replacement levels)

Study Requirements

The purpose of this study is to test an experimental drug product called ACTR087 (antibody coupled T cell receptor) in combination with another experimental drug called SEA-BCMA. 

This study tests different doses and combinations of ACTR087 and SEA-BCMA. 

The first cohort (group of participants enrolled in the study) will be given the lowest dose of ACTR087 and the lowest dose of SEA-BCMA. If the first combination of doses is found to be safe, then the next cohort will be given a higher dose of SEA-BCMA along with the lowest dose of ACTR087. As long as each combination of doses is found to be safe, the next cohort to enroll subjects will test a higher dose of either SEA-BCMA or ACTR087. The study is designed to test higher doses of ACTR087 and/or SEA-BCMA until the highest safe combination is reached. 

The duration of the study may be different for each study participant. For most participants, the study will include a screening period of up to 30 days to determine eligibility for study participation. If eligible white blood cells will be collected by leukapheresis. Following leukapheresis, study subjects begin to receive SEA-BCMA once every 21 days.

PET/CT scans are performed at screening, Day 16 of Cycle 2, at suspected Complete Response and as clinically indicated at suspected Progression of Disease. This frequency is considered standard of care treatment. 

The total amount of blood that will be needed for all of the screening tests will be about 3 teaspoons. After the screening period, if confirmed to be eligible for the study, subjects will have a visit to have the leukapheresis performed. 

Approximately 30 subjects will be treated in this study across approximately 8 sites in the United States. We expect to enroll up to 10 subjects at Tufts Medical Center.