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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03266692
Other study ID # ATTCK-17-01
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date February 22, 2018
Est. completion date October 1, 2019

Study information

Verified date March 2020
Source Unum Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date October 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Biological:
ACTR087
Autologous T cell product
SEA-BCMA
B-cell maturation antigen (BCMA)-directed antibody

Locations

Country Name City State
United States Tufts Medical Center Boston Massachusetts
United States Ohio State University Wexner Medical Center Columbus Ohio
United States Baylor Scott & White Dallas Texas
United States Indiana Blood and Marrow Transplantation Indianapolis Indiana
United States Mayo Clinic Jacksonville Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Mayo Clinic Phoenix Arizona

Sponsors (2)

Lead Sponsor Collaborator
Unum Therapeutics Inc. Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of ACTR087 in combination with SEA-BCMA Composite outcome measure assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of AEs and clinically significant abnormalities of laboratory values 28 days
Primary Determination of recommended Phase 2 dosing regimen Review of DLTs, Maximum tolerated contour (MTC), incidence and severity of AEs and clinically significant abnormalities of laboratory values 52 weeks
Secondary Safety of SEA-BCMA as measured by incidence of Treatment Emergent Adverse Events (TEAEs) Review of all TEAEs, including incidence and severity of AEs, DLTs and clinically significant abnormalities of laboratory values 21 days
Secondary Anti-myeloma activity as measured by overall response rate (per IMWG response criteria) 52 weeks
Secondary Anti-myeloma activity as measured by duration of response 52 weeks
Secondary Anti-myeloma activity as measured by progression-free survival 52 weeks
Secondary Anti-myeloma activity as measured by overall survival 52 weeks
Secondary Assessment of persistence of ACTR087 as measured by flow cytometry and qPCR 52 weeks
Secondary Assessment of ACTR087 phenotype and function as measured by flow cytometry 52 weeks
Secondary Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR087 administration Levels of inflammatory markers, cytokines/chemokines 52 weeks
Secondary SEA-BCMA PK SEA-BCMA plasma concentration 52 weeks
Secondary Assessment of anti-drug antibodies (ADA) after SEA-BCMA administration Incidence of ADAs to SEA-BCMA 52 weeks
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