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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06985576

Enrollment

Registered

2025-05-22

Start date

2026-02-26

Completion date

2041-05-01

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DLBCL - Diffuse Large B Cell Lymphoma, Follicular Lymphoma (FL), High Grade B Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Long-Term Safety of GF-CART01 after infusion	up to 15 years after GF-CART01 infusion	Percentage of subjects with ≥ grade 3 GF-CART01-related adverse events, serious adverse events (SAEs), adverse events of special interest (AESIs)

Secondary

Measure	Time frame	Description
GF-CART01 persistence	up to 15 years after GF-CART01 infusion	Measure the duration of GF-CART01 presence after cell infusion * Clast * Time of Clast
Efficacy of GF-CART01	up to 15 years after GF-CART01 infusion	Assess the overall survival (OS) up to 15 years after GF-CART01 infusion

Countries

Taiwan

Outcome results