DLBCL - Diffuse Large B Cell LymphomaNCT06985576
Long-term Study to Evaluate Safety and Persistence of GF-CART01
An observational study of DLBCL - Diffuse Large B Cell Lymphoma and Follicular Lymphoma (FL), run by GenomeFrontier Therapeutics TW Co., Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma, Follicular Lymphoma (FL), Primary Mediastinal Large B-Cell Lymphoma
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Feb 2026to May 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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 may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
The goal of this observational study is to learn about the long-term safety of GF-CART01 after cell infusion up to 15 years.
Read the 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.
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma, Follicular Lymphoma (FL), Primary Mediastinal Large B-Cell Lymphoma, High Grade B Cell Lymphoma
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-Term Safety of GF-CART01 after infusion
Percentage of subjects with ≥ grade 3 GF-CART01-related adverse events, serious adverse events (SAEs), adverse events of special interest (AESIs)
Measured: up to 15 years after GF-CART01 infusion
Secondary outcomes (2)
GF-CART01 persistence
Measure the duration of GF-CART01 presence after cell infusion
- Clast
- Time of Clast
Measured: up to 15 years after GF-CART01 infusion
Efficacy of GF-CART01
Assess the overall survival (OS) up to 15 years after GF-CART01 infusion
Measured: up to 15 years after GF-CART01 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start26 Feb 2026
- Primary completionMay 2041 (estimated)
- Study completionMay 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GenomeFrontier Therapeutics TW Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985576
- Sponsor's protocol ID
- GF-01-01e
- Status last verified
- Dec 2025
- First submitted
- 15 May 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06985576
- Acronym / sponsor ID
- GF-01-01e
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma, Follicular Lymphoma (FL), Primary Mediastinal Large B-Cell Lymphoma, High Grade B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- GenomeFrontier Therapeutics TW Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- May 2041 (estimated)
- Study completion
- May 2041 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DLBCL - Diffuse Large B Cell Lymphoma and Follicular Lymphoma (FL), run by GenomeFrontier Therapeutics TW Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-Term Safety of GF-CART01 after infusion (time frame: up to 15 years after GF-CART01 infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.