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

Cogent Biosciences, Inc.6 sites in 1 country15 target enrollmentFebruary 22, 2018

ConditionsMultiple Myeloma Multiple Myeloma in Relapse Refractory Multiple Myeloma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: Cogent Biosciences, Inc.
Enrollment: 15
Locations: 6
Primary Endpoint: Safety and tolerability of ACTR087 in combination with SEA-BCMA
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 22, 2018

End Date

October 1, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cogent Biosciences, Inc.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

Anti-myeloma activity as measured by overall survival(52 weeks)
Anti-myeloma activity as measured by progression-free survival(52 weeks)
Safety of SEA-BCMA as measured by incidence of Treatment Emergent Adverse Events (TEAEs)(21 days)
Anti-myeloma activity as measured by overall response rate (per IMWG response criteria)(52 weeks)
Anti-myeloma activity as measured by duration of response(52 weeks)
Assessment of persistence of ACTR087 as measured by flow cytometry and qPCR(52 weeks)
Assessment of ACTR087 phenotype and function as measured by flow cytometry(52 weeks)
Assessment of anti-drug antibodies (ADA) after SEA-BCMA administration(52 weeks)
Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR087 administration(52 weeks)
SEA-BCMA PK(52 weeks)