Clinical trial NCT02840110: Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product
Official title: Long-Term Follow-Up Study of Subjects Treated With an Autologous T Cell Product Expressing an Antibody-Coupled T-Cell Receptor (ACTR)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: B Cell Lymphomas
Multiple Myeloma
Solid Tumor
HER-2 Protein Overexpression
Lead sponsor: Cogent Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 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.


Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria

* None

Primary outcomes:
measure: Long-term safety of ACTR T cell product as assessed by overall survival
timeFrame: Total of 15 years after first receiving an ACTR T cell product
measure: Long-term safety of ACTR T cell product as assessed by serious adverse events related to ACTR T cell product
timeFrame: Total of 15 years after first receiving an ACTR T cell product
measure: Long-term safety of ACTR T cell product as assessed by Grade 3 or 4 adverse events related to ACTR T cell product
timeFrame: Total of 15 years after first receiving an ACTR T cell product
measure: 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
timeFrame: Total of 15 years after first receiving an ACTR T cell product
measure: ACTR T cell persistence in subjects previously treated with an ACTR T cell product
timeFrame: Total of 15 years after first receiving an ACTR T cell product
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Bone and Marrow Transplantation
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Tennessee Oncology - Nashville
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center, Charles Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Cogent Biosciences, Inc.
name: Jessica Sachs, MD
role: STUDY_DIRECTOR
References: