Multiple MyelomaPhase 1NCT03266692
Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing ACTR087 and SEA-BCMA in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Cogent Biosciences, Inc. at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma, Multiple Myeloma in Relapse, Refractory Multiple Myeloma
- What is being tested?
- ACTR087 and SEA-BCMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Feb 2018to 1 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Absolute neutrophil (ANC) count greater than 1000/ µL
- Platelet count greater than 50,000/µL
- Estimated GFR >30mL/min/1.73m2
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Baylor Scott & White
Dallas, Texas, 75246
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46327
Mayo Clinic
Jacksonville, Florida, 32224
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mayo Clinic
Phoenix, Arizona, 85054
About this study
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
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.
- Being tested
- ACTR087, SEA-BCMA
- 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
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTR087Biological
Autologous T cell product
SEA-BCMABiological
B-cell maturation antigen (BCMA)-directed antibody
| Study group | Role | What they receive |
|---|---|---|
| ACTR087 in combination with SEA-BCMA | Experimental | Not described Receives: Biological: ACTR087; Biological: SEA-BCMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
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
Measured: 52 weeks
Secondary outcomes (10)
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
Measured: 21 days
Anti-myeloma activity as measured by overall response rate (per IMWG response criteria)
Measured: 52 weeks
Anti-myeloma activity as measured by duration of response
Measured: 52 weeks
Anti-myeloma activity as measured by progression-free survival
Measured: 52 weeks
Anti-myeloma activity as measured by overall survival
Measured: 52 weeks
Assessment of persistence of ACTR087 as measured by flow cytometry and qPCR
Measured: 52 weeks
Assessment of ACTR087 phenotype and function as measured by flow cytometry
Measured: 52 weeks
Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR087 administration
Levels of inflammatory markers, cytokines/chemokines
Measured: 52 weeks
SEA-BCMA PK
SEA-BCMA plasma concentration
Measured: 52 weeks
Assessment of anti-drug antibodies (ADA) after SEA-BCMA administration
Incidence of ADAs to SEA-BCMA
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start22 Feb 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cogent Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seagen Inc.
- Responsible party
- Sponsor
- Investigators
- Jessica Sachs, MD, Study director, Cogent Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266692
- Sponsor's protocol ID
- ATTCK-17-01
- Status last verified
- Mar 2020
- First submitted
- 22 Aug 2017
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03266692
- Acronym / sponsor ID
- ATTCK-17-01
- Keywords
- BCMA, SEA-BCMA, B Cell Maturation Antigen, ACTR, ACTR087, T cell, T cell product, relapsed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cogent Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Seagen Inc.
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACTR087 in combination with SEA-BCMA | Experimental | Biological: ACTR087, Biological: SEA-BCMA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTR087Autologous T cell product | Biological | ACTR087 in combination with SEA-BCMA |
| SEA-BCMAB-cell maturation antigen (BCMA)-directed antibody | Biological | ACTR087 in combination with SEA-BCMA |
Primary outcome
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
10 secondary outcomes
Safety of SEA-BCMA as measured by incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: 21 days
Anti-myeloma activity as measured by overall response rate (per IMWG response criteria)
Time frame: 52 weeks
Anti-myeloma activity as measured by duration of response
Time frame: 52 weeks
Anti-myeloma activity as measured by progression-free survival
Time frame: 52 weeks
Anti-myeloma activity as measured by overall survival
Time frame: 52 weeks
Assessment of persistence of ACTR087 as measured by flow cytometry and qPCR
Time frame: 52 weeks
Assessment of ACTR087 phenotype and function as measured by flow cytometry
Time frame: 52 weeks
Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR087 administration
Time frame: 52 weeks
SEA-BCMA PK
Time frame: 52 weeks
Assessment of anti-drug antibodies (ADA) after SEA-BCMA administration
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Sachs, MD study director
Cogent Biosciences, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACTR087 and SEA-BCMA in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Cogent Biosciences, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of ACTR087 in combination with SEA-BCMA (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.