Long-term Study to Evaluate Safety and Persistence of GF-CART01

GenomeFrontier Therapeutics TW Co., Ltd.

Status: Begins enrollment in 2 months

Conditions: Primary Mediastinal Large B-Cell Lymphoma; High Grade B Cell Lymphoma; Follicular Lymphoma (FL); DLBCL - Diffuse Large B Cell Lymphoma

Study type: Observational

Funder types: Industry

Identifiers

NCT06985576

GF-01-01e

Details and patient eligibility

About

The goal of this observational study is to learn about the long-term safety of GF-CART01 after cell infusion up to 15 years.

Full description

This comprehensive long-term follow-up study is meticulously designed to assess the safety and persistence of GF-CART01. Subjects who participated in the initial study of GF-01-01 and received treatment with GF-CART01, irrespective of their completion status, are eligible to participate in this follow-up study. The study may allow for a maximum enrollment of 18 subjects.

Enrollment: 18 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Subjects previously enrolled in the study of GF-CART01 (Protocol No.: GF-01-01) and received GF-CART01 infusion
2. Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent
3. Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement

Exclusion Criteria: None

Trial design

18 participants in 1 patient group

LTFU

Description:

Subjects who participated in the initial study of GF-01-01 and received treatment with GF-CART01, irrespective of their completion status, are invited to participate in this follow-up study.