Status:
TERMINATED
Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Cogent Biosciences, Inc.
Collaborating Sponsors:
Seagen Inc.
Conditions:
Multiple Myeloma
Multiple Myeloma in Relapse
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03266692
Start Date
February 22 2018
End Date
October 1 2019
Last Update
March 30 2020
Active Locations (7)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
3
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States, 46327
4
Tufts Medical Center
Boston, Massachusetts, United States, 02111