B Cell LymphomasNCT02840110
Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product
An observational study of B Cell Lymphomas and Multiple Myeloma, run by Cogent Biosciences, Inc. at 16 sites in United States.
Trial summary
Subjects treated with an ACTR product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cell Lymphomas, Multiple Myeloma, Solid Tumor
- What is being tested?
- ACTR T Cell Product
- How many people
- 22 participants
- Where
- 16 sitesUnited States
- Study dates
- Oct 2016to 23 Feb 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects with disease progression after being treated with at least one dose of an ACTR T cell product in the parent study or other investigational setting
Who may be able to join
- Willing to provide informed consent for participation in the study
- Received at least 1 dose of an ACTR T cell product in an investigational or other treatment setting, such as compassionate use, named patient IND, expanded access program, or equivalent settings
- Has completed study assessments and follow-up visits in the prior study or other investigational setting to the extent willing and able to do so
- Able to comply with study requirements
Who cannot join
- None
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
University of Maryland
Baltimore, Maryland, 21201
Tufts Medical Center
Boston, Massachusetts, 02111
Ohio State University
Columbus, Ohio, 43210
Baylor University Medical Center, Charles Sammons Cancer Center
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 27710
Banner MD Anderson
Gilbert, Arizona, 85234
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana Bone and Marrow Transplantation
Indianapolis, Indiana, 46237
Mayo Clinic Florida
Jacksonville, Florida, 32224
Loyola University
Maywood, Illinois, 60153
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
Tennessee Oncology - Nashville
Nashville, Tennessee, 37203
Yale University
New Haven, Connecticut, 06520
Mayo Clinic Arizona
Phoenix, Arizona, 85054
About this study
Official title: Long-Term Follow-Up Study of Subjects Treated With an Autologous T Cell Product Expressing an Antibody-Coupled T-Cell Receptor (ACTR)
Subjects treated with an ACTR product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. No investigational product or treatment will be administered in this study. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.
- Being tested
- ACTR T Cell Product
- Medical subject headings
- Lymphoma, B-Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTR T Cell ProductOther
| Study group | Role | What they receive |
|---|---|---|
| Post-ACTR | Subjects who have previously been treated with an ACTR T cell product Receives: Other: ACTR T Cell Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of ACTR T cell product as assessed by overall survival
Measured: Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by serious adverse events related to ACTR T cell product
Measured: Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by Grade 3 or 4 adverse events related to ACTR T cell product
Measured: Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by adverse events of special interest, regardless of grade or relatedness to the ACTR T cell product
Measured: Total of 15 years after first receiving an ACTR T cell product
ACTR T cell persistence in subjects previously treated with an ACTR T cell product
Measured: Total of 15 years after first receiving an ACTR T cell product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startOct 2016
- Primary completion23 Oct 2020
- Study completion23 Feb 2021
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell LymphomasStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cogent Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica Sachs, MD, Study director, Cogent Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840110
- Sponsor's protocol ID
- UT-201502
- Status last verified
- Oct 2021
- First submitted
- 13 Jul 2016
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up Study of Subjects Treated With an Autologous T Cell Product Expressing an Antibody-Coupled T-Cell Receptor (ACTR)
- ClinicalTrials.gov ID
- NCT02840110
- Acronym / sponsor ID
- UT-201502
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cogent Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 21 Jul 2016 (estimated)
- 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.
Subjects treated with an ACTR product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. No investigational product or treatment will be administered in this study. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-ACTR | – | Other: ACTR T Cell ProductSubjects who have previously been treated with an ACTR T cell product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects with disease progression after being treated with at least one dose of an ACTR T cell product in the parent study or other investigational setting
Key inclusion criteria (4 listed)
- Willing to provide informed consent for participation in the study
- Received at least 1 dose of an ACTR T cell product in an investigational or other treatment setting, such as compassionate use, named patient IND, expanded access program, or equivalent settings
- Has completed study assessments and follow-up visits in the prior study or other investigational setting to the extent willing and able to do so
- Able to comply with study requirements
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ACTR T Cell Product | Other | Post-ACTR |
Primary outcome
Long-term safety of ACTR T cell product as assessed by overall survival
Time frame: Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by serious adverse events related to ACTR T cell product
Time frame: Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by Grade 3 or 4 adverse events related to ACTR T cell product
Time frame: Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by adverse events of special interest, regardless of grade or relatedness to the ACTR T cell product
Time frame: Total of 15 years after first receiving an ACTR T cell product
ACTR T cell persistence in subjects previously treated with an ACTR T cell product
Time frame: Total of 15 years after first receiving an ACTR T cell product
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: No
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B Cell Lymphomas and Multiple Myeloma, run by Cogent Biosciences, Inc. at 16 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 4 inclusion and 1 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 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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.
Are results available for this study?
The study was stopped early (reason given: Business Decision). 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?
Long-term safety of ACTR T cell product as assessed by overall survival (time frame: Total of 15 years after first receiving an ACTR T cell product). The study lists 5 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 11 Oct 2021.