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

This study is not yet open for participant recruitment.
Verified August 2017 by Unum Therapeutics Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03266692
First Posted: August 30, 2017
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Unum Therapeutics Inc.
  Purpose
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.

Condition Intervention Phase
Multiple Myeloma Multiple Myeloma in Relapse Refractory Multiple Myeloma Biological: ACTR087 Biological: SEA-BCMA Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Unum Therapeutics Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACTR087 in combination with SEA-BCMA Biological: ACTR087
Autologous T cell product
Biological: SEA-BCMA
B-cell maturation antigen (BCMA)-directed antibody

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Iga Sienczylo 617-945-5576 ext 238 iga.sienczylo@unumrx.com
Contact: Jessica Sachs, MD 617-286-6604 jessica.sachs@unumrx.com

Sponsors and Collaborators
Unum Therapeutics Inc.
Seattle Genetics, Inc.
Investigators
Study Director: Jessica Sachs, MD Unum Therapeutics Inc.
  More Information

Responsible Party: Unum Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03266692     History of Changes
Other Study ID Numbers: ATTCK-17-01
First Submitted: August 22, 2017
First Posted: August 30, 2017
Last Update Posted: August 30, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Unum Therapeutics Inc.:
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

Additional relevant MeSH terms:
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