Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

a study on Neoplasms

Summary

Location
at UCLA UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Sarah M. Larson, MD (ucla)
Headshot of Sarah M. Larson
Sarah M. Larson

Description

Summary

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.

Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Official Title

Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

Keywords

Neoplasms, Long-term follow up, Gene-Modified T Cells, CAR T Cell, Gene-modified (GM) T cell therapy

Eligibility

You can join if…

  • Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored or Celgene alliance partner-sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
  • Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.

You CAN'T join if...

Not Applicable

Other protocol-defined inclusion/exclusion criteria apply

Locations

  • University Of California San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • University of California, San Francisco- California accepting new patients
    San Francisco California 94143 United States
  • UCLA Medical Centre-Santa Monica accepting new patients
    Santa Monica California 90095 United States
  • Local Institution - 01206 withdrawn
    Los Angeles California 90048 United States
  • Local Institution - 01043 withdrawn
    Sacramento California 95816 United States
  • City Of Hope accepting new patients
    Duarte California 91010-301 United States
  • Local Institution - 01119 not yet accepting patients
    Stanford California 94305 United States

Lead Scientist at University of California Health

  • Sarah M. Larson, MD (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 21 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
BMS Clinical Trial Information
ID
NCT03435796
Phase
Phase 2/3 Neoplasms Research Study
Study Type
Interventional
Participants
Expecting 317 study participants
Last Updated