ong-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells.

Phase 1

• Conditions: Defined by parent protocol. The study will enroll all adult and paediatric subjects who received at least one genetically modified T cells infusion in a previous Celgene sponsored study (see protocol section 4.2). Initially it is planned to enroll patients from parent studies BB2121-MM-001 (EudraCT 2017-002245-29; for adult patients with relapsed and refractory multiple myeloma) and JCAR017-BCM-001 (EudraCT 2017-000106-38; for adult subjects with aggressive B-Cell Non-Hodgkin Lymphoma).; MedDRA version: 20.0 Level: LLT Classification code 10025631 Term: Malignant lymphoid neoplasm NOS System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001465-24-ES
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-21
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 218

Inclusion Criteria

1. All adult and pediatric subjects who 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. Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign an ICF/IAF prior to any study-related assessments/procedures being
conducted.
3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 118
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Not Applicable.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified