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.
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
Drug | Synonyms | Arms |
---|
ACTR087 | | ACTR087 in combination with SEA-BCMA |
SEA-BCMA | | ACTR087 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
Name | Type | Description | Interventions |
---|
ACTR087 in combination with SEA-BCMA | Experimental | | |
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: | Terminated |
Lead Sponsor: | Cogent Biosciences, 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
March 30, 2020