Clinical Trials /

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

NCT03266692

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: ATTCK-17-01
  • NCT ID: NCT03266692

Conditions

  • Multiple Myeloma
  • Multiple Myeloma in Relapse
  • Refractory Multiple Myeloma

Interventions

DrugSynonymsArms
ACTR087ACTR087 in combination with SEA-BCMA
SEA-BCMAACTR087 in combination with SEA-BCMA

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.

Trial Arms

NameTypeDescriptionInterventions
ACTR087 in combination with SEA-BCMAExperimental
  • ACTR087
  • SEA-BCMA

Eligibility 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
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability of ACTR087 in combination with SEA-BCMA
Time Frame:28 days
Safety Issue:
Description:Composite outcome measure assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of AEs and clinically significant abnormalities of laboratory values

Secondary Outcome Measures

Measure:Safety of SEA-BCMA as measured by incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame:21 days
Safety Issue:
Description:Review of all TEAEs, including incidence and severity of AEs, DLTs and clinically significant abnormalities of laboratory values
Measure:Anti-myeloma activity as measured by overall response rate (per IMWG response criteria)
Time Frame:52 weeks
Safety Issue:
Description:
Measure:Anti-myeloma activity as measured by duration of response
Time Frame:52 weeks
Safety Issue:
Description:
Measure:Anti-myeloma activity as measured by progression-free survival
Time Frame:52 weeks
Safety Issue:
Description:
Measure:Anti-myeloma activity as measured by overall survival
Time Frame:52 weeks
Safety Issue:
Description:
Measure:Assessment of persistence of ACTR087 as measured by flow cytometry and qPCR
Time Frame:52 weeks
Safety Issue:
Description:
Measure:Assessment of ACTR087 phenotype and function as measured by flow cytometry
Time Frame:52 weeks
Safety Issue:
Description:
Measure:Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR087 administration
Time Frame:52 weeks
Safety Issue:
Description:Levels of inflammatory markers, cytokines/chemokines
Measure:SEA-BCMA PK
Time Frame:52 weeks
Safety Issue:
Description:SEA-BCMA plasma concentration
Measure:Assessment of anti-drug antibodies (ADA) after SEA-BCMA administration
Time Frame:52 weeks
Safety Issue:
Description:Incidence of ADAs to SEA-BCMA

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Unum Therapeutics Inc.

Trial Keywords

  • 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

Last Updated

July 26, 2019