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Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840110
Recruitment Status : Enrolling by invitation
First Posted : July 21, 2016
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Unum Therapeutics Inc.

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.

Condition or disease Intervention/treatment
B Cell Lymphomas Multiple Myeloma Solid Tumor HER-2 Protein Overexpression Other: ACTR T Cell Product

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Start Date : October 2016
Estimated Primary Completion Date : December 2035
Estimated Study Completion Date : December 2035


Group/Cohort Intervention/treatment
Post-ACTR
Subjects who have previously been treated with an ACTR T cell product
Other: ACTR T Cell Product



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Biospecimen Retention:   Samples With DNA

Blood for replication competent retrovirus (RCR) testing

Remaining biological samples from other protocol procedures (e.g., blood for presence of ACTR+ T cells) may also be stored, at the discretion of the sponsor, for potential future biomarker analyses of T cells, DNA, RNA, and other cells or molecules to study immunology or gene therapy.

Optional blood, bone marrow, and tissue samples also may be collected in the event of a subject's death if an autopsy is performed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840110


Locations
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United States, Arizona
Banner MD Anderson
Gilbert, Arizona, United States, 85234
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
Loyola University
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana Bone and Marrow Transplantation
Indianapolis, Indiana, United States, 46237
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Tennessee
Tennessee Oncology - Nashville
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor University Medical Center, Charles Sammons Cancer Center
Dallas, Texas, United States, 75246
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Unum Therapeutics Inc.
Investigators
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Study Director: Jessica Sachs, MD Unum Therapeutics Inc.
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Responsible Party: Unum Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02840110    
Other Study ID Numbers: UT-201502
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases