Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT03266692 |
Recruitment Status :
Terminated
(Business reasons)
First Posted : August 30, 2017
Last Update Posted : March 30, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma Multiple Myeloma in Relapse Refractory Multiple Myeloma | Biological: ACTR087 Biological: SEA-BCMA | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Study of ACTR087, an Autologous T Cell Product, in Combination With SEA-BCMA, a Monoclonal Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma |
Actual Study Start Date : | February 22, 2018 |
Actual Primary Completion Date : | October 1, 2019 |
Actual Study Completion Date : | October 1, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: ACTR087 in combination with SEA-BCMA |
Biological: ACTR087
Autologous T cell product Biological: SEA-BCMA B-cell maturation antigen (BCMA)-directed antibody |
- Safety and tolerability of ACTR087 in combination with SEA-BCMA [ Time Frame: 28 days ]Composite outcome measure assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of AEs and clinically significant abnormalities of laboratory values
- Determination of recommended Phase 2 dosing regimen [ Time Frame: 52 weeks ]Review of DLTs, Maximum tolerated contour (MTC), incidence and severity of AEs and clinically significant abnormalities of laboratory values
- Safety of SEA-BCMA as measured by incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 21 days ]Review of all TEAEs, including incidence and severity of AEs, DLTs and clinically significant abnormalities of laboratory values
- Anti-myeloma activity as measured by overall response rate (per IMWG response criteria) [ Time Frame: 52 weeks ]
- Anti-myeloma activity as measured by duration of response [ Time Frame: 52 weeks ]
- Anti-myeloma activity as measured by progression-free survival [ Time Frame: 52 weeks ]
- Anti-myeloma activity as measured by overall survival [ Time Frame: 52 weeks ]
- Assessment of persistence of ACTR087 as measured by flow cytometry and qPCR [ Time Frame: 52 weeks ]
- Assessment of ACTR087 phenotype and function as measured by flow cytometry [ Time Frame: 52 weeks ]
- Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR087 administration [ Time Frame: 52 weeks ]Levels of inflammatory markers, cytokines/chemokines
- SEA-BCMA PK [ Time Frame: 52 weeks ]SEA-BCMA plasma concentration
- Assessment of anti-drug antibodies (ADA) after SEA-BCMA administration [ Time Frame: 52 weeks ]Incidence of ADAs to SEA-BCMA

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266692
United States, Arizona | |
Mayo Clinic | |
Phoenix, Arizona, United States, 85054 | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
United States, Indiana | |
Indiana Blood and Marrow Transplantation | |
Indianapolis, Indiana, United States, 46327 | |
United States, Massachusetts | |
Tufts Medical Center | |
Boston, Massachusetts, United States, 02111 | |
United States, Ohio | |
Ohio State University Wexner Medical Center | |
Columbus, Ohio, United States, 43210 | |
United States, Texas | |
Baylor Scott & White | |
Dallas, Texas, United States, 75246 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Study Director: | Jessica Sachs, MD | Cogent Biosciences, Inc. |
Responsible Party: | Cogent Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT03266692 |
Other Study ID Numbers: |
ATTCK-17-01 |
First Posted: | August 30, 2017 Key Record Dates |
Last Update Posted: | March 30, 2020 |
Last Verified: | March 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
BCMA SEA-BCMA B Cell Maturation Antigen ACTR ACTR087 T cell T cell product |
relapsed refractory multiple myeloma adoptive T cells autologous gene therapy cell therapy |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |