Long-term Study to Evaluate Safety and Persistence of GF-CART01
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: DLBCL - Diffuse Large B Cell Lymphoma, Follicular Lymphoma (FL), Primary Mediastinal Large B-Cell Lymphoma, High Grade B Cell Lymphoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Long-term Follow-up Study of GF-01-01 to Evaluate the Safety and Persistence of GF-CART01 (CD20/19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies
Overview
The goal of this observational study is to learn about the long-term safety of GF-CART01 after cell infusion up to 15 years.
Detailed 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.
Primary outcome measures
- Long-Term Safety of GF-CART01 after infusion [Time frame: up to 15 years after GF-CART01 infusion]
Secondary outcome measures (2)
- GF-CART01 persistence [Time frame: up to 15 years after GF-CART01 infusion]
- Efficacy of GF-CART01 [Time frame: up to 15 years after GF-CART01 infusion]
Eligibility criteria
Inclusion criteria
- Subjects previously enrolled in the study of GF-CART01 (Protocol No.: GF-01-01) and received GF-CART01 infusion
- Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent
- Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement
Exclusion Criteria: None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT06985576 · GF-01-01e