ong-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Phase 2
Recruiting
- Conditions
- eoplasms
- Registration Number
- JPRN-jRCT2033230513
- Lead Sponsor
- Hayakawa Jin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 77
Inclusion Criteria
1. 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.
2. Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
Exclusion Criteria
Not Applicable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess the risk of delayed adverse events following exposure to GM T cells<br>2. To monitor for long-term persistence of GM T cells, including analysis of vector integration sites, as appropriate<br>3. To monitor for generation of replication-competent lentiviruses<br>4. To assess long-term efficacy following treatment with GM T cells<br>5. Describe growth and sexual maturity status for subjects who were aged < 18 years at time of GM T-cell treatment
- Secondary Outcome Measures
Name Time Method 1. To monitor for B-cell levels in subjects who received CD19-directed GM T-cell therapy