Study Stopped
Business reasons
Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma
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
1 other identifier
interventional
15
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 multiple-myeloma
Started Feb 2018
Shorter than P25 for phase_1 multiple-myeloma
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
February 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedMarch 30, 2020
March 1, 2020
1.6 years
August 22, 2017
March 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety and tolerability of ACTR087 in combination with SEA-BCMA
Composite outcome measure assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of AEs and clinically significant abnormalities of laboratory values
28 days
Determination of recommended Phase 2 dosing regimen
Review of DLTs, Maximum tolerated contour (MTC), incidence and severity of AEs and clinically significant abnormalities of laboratory values
52 weeks
Secondary Outcomes (10)
Safety of SEA-BCMA as measured by incidence of Treatment Emergent Adverse Events (TEAEs)
21 days
Anti-myeloma activity as measured by overall response rate (per IMWG response criteria)
52 weeks
Anti-myeloma activity as measured by duration of response
52 weeks
Anti-myeloma activity as measured by progression-free survival
52 weeks
Anti-myeloma activity as measured by overall survival
52 weeks
- +5 more secondary outcomes
Study Arms (1)
ACTR087 in combination with SEA-BCMA
EXPERIMENTALInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cogent Biosciences, Inc.lead
- Seagen Inc.collaborator
Study Sites (7)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46327, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Baylor Scott & White
Dallas, Texas, 75246, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jessica Sachs, MD
Cogent Biosciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2017
First Posted
August 30, 2017
Study Start
February 22, 2018
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
March 30, 2020
Record last verified: 2020-03