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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-05-31

Study Completion Date

2041-05-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LTFU

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.

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Howard Cheng

Role: CONTACT

Phone: +886-2-2655-8766

Email: [email protected]

n

Role: CONTACT

Facility Contacts

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Shang-Ju Wu, M.D., Ph.D.

Role: primary

Other Identifiers

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GF-01-01e

Identifier Type: -

Identifier Source: org_study_id