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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-22

Study Completion Date

2019-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Myeloma Multiple Myeloma in Relapse Refractory Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACTR087 in combination with SEA-BCMA

Group Type EXPERIMENTAL

ACTR087

Intervention Type BIOLOGICAL

Autologous T cell product

SEA-BCMA

Intervention Type BIOLOGICAL

B-cell maturation antigen (BCMA)-directed antibody

Interventions

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ACTR087

Autologous T cell product

Intervention Type BIOLOGICAL

SEA-BCMA

B-cell maturation antigen (BCMA)-directed antibody

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No