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 Larson (ucla)

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  • Local Institution - 01206 withdrawn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  • Local Institution - 01043 withdrawn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 Larson (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 20 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