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



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 80
Updated:3/6/2019
Start Date:February 22, 2018
End Date:March 2021
Contact:Iga Sienczylo
Email:iga.sienczylo@unumrx.com
Phone:617-945-5576

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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

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.


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
We found this trial at
7
sites
660 Hall Street
Dallas, Texas 75246
Principal Investigator: Houston Holmes III, MD
Phone: 214-818-8325
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Cindy Varga, MD
Phone: 617-636-8589
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Sikander Ailawadhi, MD
Phone: 904-953-3376
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Don Benson, MD
Phone: 614-685-6059
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Indianapolis, Indiana 46237
Principal Investigator: Luke P Akard, MD
Phone: 317-528-5500
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Indianapolis, IN
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Parameswaran Hari, MD
Phone: 414-805-8378
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
Principal Investigator: Jeremy T Larsen, MD
Phone: 480-342-6068
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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