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

JRCT ID: jRCT2033230513

Registered date:15/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neoplasms
• Date of first enrollment: 15/12/2023
• Target sample size: 77
• Countries of recruitment: Austria,Japan,Belgium,Japan,Canada,Japan,Finland,Japan,France,Japan,Germany,Japan,Italy,Japan,Netherlands,Japan,Norway,Japan,Spain,Japan,Sweden,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Gene-Modified T cell therapy (No investigational product will be administered in this study)

Outcome(s)

Primary Outcome

1. To assess the risk of delayed adverse events following exposure to GM T cells
2. To monitor for long-term persistence of GM T cells, including analysis of vector integration sites, as appropriate
3. To monitor for generation of replication-competent lentiviruses
4. To assess long-term efficacy following treatment with GM T cells
5. Describe growth and sexual maturity status for subjects who were aged < 18 years at time of GM T-cell treatment

• Secondary Outcome: 1. To monitor for B-cell levels in subjects who received CD19-directed GM T-cell therapy

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.

• Exclude criteria: Not Applicable

Related Information

• Primary Sponsor: Hayakawa Jin
• Secondary ID(s): NCT03435796