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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
Sponsor:
Collaborator:
Seagen Inc.
Information provided by (Responsible Party):
Cogent Biosciences, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Multiple Myeloma in Relapse Refractory Multiple Myeloma Biological: ACTR087 Biological: SEA-BCMA Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 :
  1. 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

  2. Anti-myeloma activity as measured by overall response rate (per IMWG response criteria) [ Time Frame: 52 weeks ]
  3. Anti-myeloma activity as measured by duration of response [ Time Frame: 52 weeks ]
  4. Anti-myeloma activity as measured by progression-free survival [ Time Frame: 52 weeks ]
  5. Anti-myeloma activity as measured by overall survival [ Time Frame: 52 weeks ]
  6. Assessment of persistence of ACTR087 as measured by flow cytometry and qPCR [ Time Frame: 52 weeks ]
  7. Assessment of ACTR087 phenotype and function as measured by flow cytometry [ Time Frame: 52 weeks ]
  8. Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR087 administration [ Time Frame: 52 weeks ]
    Levels of inflammatory markers, cytokines/chemokines

  9. SEA-BCMA PK [ Time Frame: 52 weeks ]
    SEA-BCMA plasma concentration

  10. Assessment of anti-drug antibodies (ADA) after SEA-BCMA administration [ Time Frame: 52 weeks ]
    Incidence of ADAs to SEA-BCMA


Eligibility Criteria
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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
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
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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


Locations
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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
Sponsors and Collaborators
Cogent Biosciences, Inc.
Seagen Inc.
Investigators
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Study Director: Jessica Sachs, MD Cogent Biosciences, Inc.
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cogent Biosciences, 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:
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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