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

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Myeloma; Solid Tumor; HER-2 Protein Overexpression; B Cell Lymphomas
• Intervention / Treatment: Other: ACTR T Cell Product

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Winship Cancer Institute
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indiana Bone and Marrow Transplantation
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology - Nashville
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center, Charles Sammons Cancer Center
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Long-term safety of ACTR T cell product as assessed by overall survival	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	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	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	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	Total of 15 years after first receiving an ACTR T cell product

Collaborators and Investigators

• Sponsor: Cogent Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ACTUAL): October 23, 2020
• Study Completion (ACTUAL): February 23, 2021

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (ESTIMATE): July 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Multiple Myeloma
• Other Study ID Numbers: UT-201502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO