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

NCT02840110 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2021-10-11

No results posted yet for this study

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.

Conditions

Interventions

OTHER

ACTR T Cell Product

Sponsors & Collaborators

  • Cogent Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Jessica Sachs, MD · Cogent Biosciences, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2020-10-23
Completion
2021-02-23

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02840110 on ClinicalTrials.gov