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Enrolling by Invitation

NCT Number: NCT06985576

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

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

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Key information

Conditions

DLBCL - Diffuse Large B Cell Lymphoma Dendritic Cell Sarcoma, Interdigitating Follicular Lymphoma (FL) Hemic and Lymphatic Diseases High Grade B Cell Lymphoma Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Primary Mediastinal Large B-Cell Lymphoma

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Long-Term Safety of GF-CART01 after infusion

    Time frame: 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 outcomes

  1. GF-CART01 persistence

    Time frame: up to 15 years after GF-CART01 infusion

    Measure the duration of GF-CART01 presence after cell infusion

    • Clast
    • Time of Clast

  2. Efficacy of GF-CART01

    Time frame: up to 15 years after GF-CART01 infusion

    Assess the overall survival (OS) up to 15 years after GF-CART01 infusion

Sponsors and collaborators

Lead sponsor

GenomeFrontier Therapeutics TW Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2041
Study completion
2041
First posted
May 22, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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