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AzTrials

Diffuse Large B Cell Lymphoma RelapsedPhase 1CD20/19 CAR TNCT06703892

A Study to Evaluate the Safety and Clinical Activity of GF- CART01 (CD20/19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies

A Phase 1 study testing GF-CART01 in people with Diffuse Large B Cell Lymphoma Relapsed and Diffuse Large B Cell Lymphoma Refractory, run by GenomeFrontier Therapeutics TW Co., Ltd. at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Phase I, prospective, dose-finding study to evaluate the safety, persistence, and clinical activity of GF-CART01 in subjects aged 18-70 with relapsed or refractory (R/R) B-cell hematological malignancies and failure of two-line or more standard chemotherapies or auto-hematopoietic stem cell transplantation… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
GF-CART01
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteTaiwan
Study dates
9 Jun 2025to Dec 2027
Phase
Phase 1
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be of age ≥ 18 years and ≤ 70 years
  • Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent
  • Histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma - Not Otherwise Specified (DLBCL-NOS), follicular lymphoma (FL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), or High-Grade B-Cell Lymphoma (HGBCL) per the world health organization (WHO) Classification Criteria for Lymphoma (2022)
  • Tumor cell surface expression of CD19 (+) and/or CD20 (+) by flow cytometry or immunohistochemistry staining
  • Relapsed, progressive or refractory disease (defined as have not achieved a complete response) after ≥ two lines of systemic therapy, including anti-CD20 antibody and anthracycline and/or Relapsed, progressive or refractory disease ( defined as have not achieved a complete response) after auto-HSCT
  • Subjects have any accessible PET-positive lesion or measurable CT-positive lesion per Lugano 2014 criteria
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  • Adequate hematologic function: absolute neutrophil count (ANC) > 1,000/μL, absolute lymphocyte count (ALC) > 300/μL, platelet count ≥ 75,000/μL, hemoglobin ≥ 8.0 g/dL
  • Adequate hepatic function: alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN), aspartate transaminase (AST) ≤ 5 times ULN, total bilirubin ≤ 1.5 times ULN
  • Adequate renal function: blood estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2 (calculated by Modification of Diet in Renal Disease (MDRD) equation)
  • Adequate cardiac function: echocardiogram or multigated blood pool analysis (MUGA) shows left ventricular ejection fraction (LVEF) ≥ 50%; and no clinically significant electrocardiogram (ECG) findings
  • Adequate pulmonary function: no active infection in the lungs, blood oxygen saturation in indoor air ≥ 92%
  • No clinically significant pleural effusion determined by the investigators
  • Estimated survival time ≥ 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement

Who cannot join

  • Previously treated with any CAR T cell product or allogenic hematopoietic stem cell transplant (HSCT)
  • Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of the investigational product (IP)
  • Known medical history or possible risk for taking contrast agent(s) for positron emission tomography (PET) and/or computed tomography (CT) scan
  • Received any other investigational product, cell therapy, or gene therapy within 12 weeks prior to the leukapheresis
  • Received any tyrosine kinase inhibitor within 2 weeks prior to the leukapheresis
  • Received any systemic steroid, immunotherapy (such as immune checkpoint inhibitors, T- cell transfer therapies, monoclonal antibodies), or chemotherapy within 4 weeks prior to the leukapheresis
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  • Received any live vaccine from 2 weeks prior to the leukapheresis
  • Subjects with human immunodeficiency virus (HIV), syphilis, Hepatitis B or C infection: HIV-1 and HIV-2 antibody positive, syphilis antibody positive, both hepatitis B virus (HBV) DNA and hepatitis B core (HBc) antibody positive, or hepatitis C virus (HCV) antibody positive
  • Subjects with atrial or ventricular involvement by B-cell malignancies
  • Subjects with tumor mass requiring urgent treatment within 8 weeks prior to the leukapheresis, such as ileus, tumor lysis syndrome, or vascular compression
  • Subjects with severe disease or other uncontrolled diseases, such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia (urgent intervention indicated, life- threatening consequences, or hemodynamic compromise), cardiac angioplasty or stenting, unstable angina, cerebral thrombosis, cerebral hemorrhage, hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
  • Unstable pulmonary embolism, deep venous embolism, or other major arterial/venous thromboembolism events that occurred within 6 weeks prior to the leukapheresis. If subjects receive anticoagulant therapy, the treatment dose and frequency must be stable for more than 14 weeks prior to the leukapheresis
  • History of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic diseases, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement
  • Female subject of childbearing potential who: a. Has positive pregnancy test result; or b. Is lactating
  • Female subjects of childbearing potential, or male subject with female spouse/partner of childbearing potential, who refuses to adopt at least one form of birth control from the date of signing informed consent to 12 months after GF-CART01 infusion. Acceptable forms of birth control include: a. Established use of oral, injected or implanted hormonal methods of contraception b. Placement of an intrauterine device (IUD) or intrauterine system (IUS) c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)
  • Any following situations that the investigators believe are not suitable for this trial and/or may increase the risk for subjects or interfere with the results of the study a. With severe active infections (except simple urinary tract infection and bacterial pharyngitis) b. With active central nervous system involvement by lymphoma, malignant cells in cerebrospinal fluid c. History of brain metastasis d. With uncontrolled malignancies e. Any toxicities due to prior therapy f. With any uncontrolled illness or a history of any illness

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Howard Cheng contact

+886-2-2655-8766

howardcheng@genomefrontier.com

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital

    Taipei

    Shang-Ju Wu, MD, PhD, +886-2-23123456, wushangju@ntuh.gov.tw

    Shang-Ju Wu, MD, PhD

    Recruiting

Other trials in Taiwan

About this study

Official title: An Open-Label, Non-Randomized, Phase I, Prospective, Dose- Finding Study to Evaluate the Safety and Clinical Activity of GF- CART01 (CD20/19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies

This is a Phase I, prospective, dose-finding study to evaluate the safety, persistence, and clinical activity of GF-CART01 in subjects aged 18-70 with relapsed or refractory (R/R) B-cell hematological malignancies and failure of two-line or more standard chemotherapies or auto-hematopoietic stem cell transplantation (HSCT).This study is a traditional 3+3 dose-escalation design to observe dose-limiting toxicity (DLT), establish the maximum tolerated dose(MTD)/recommended phase 2 doses (RP2D), and preliminary efficacy of GF-CART01. RP2D may equal to or lower than MTD

Being tested
GF-CART01
Keywords
CAR T
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GF-CART01Biological

    CAR positive viable T cells-Mid

  • GF-CART01Biological

    CAR positive viable T cells-High

  • GF-CART01Biological

    CAR positive viable T cells-Low

Study groups in NCT06703892
Study groupRoleWhat they receive
GF-CART01ExperimentalCAR-positive viable T cells
Receives: Biological: GF-CART01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD)

    Percentage of subjects with dose-limiting toxicity (DLT) from Visit 4 (Day 1) to Visit 9 (Day 29) after GF-CART01 cell infusion

    Measured: From Day 1 to 28 days after cell infusion

  2. Safety and tolerability of GF-CART01

    Percentage of subjects with treatment-emergent adverse events (TEAEs), ≥ grade 3 TEAEs, serious adverse events (SAEs), adverse events of special interest (AESIs)

    Measured: From Day 1 to 1 year after cell infusion

Secondary outcomes (9)

  1. Preliminary efficacy of GF-CART01-ORR

    Measure overall response rate (ORR) from Visit 4 (Day 1) to Visit 16 (Year 1) by Lugano 2014 criteria

    Measured: From Day 1 to 1 year after cell infusion

  2. Preliminary efficacy of GF-CART01-DOR

    Measure duration of response (DOR) from Visit 4 (Day 1) to Visit 16 (Year 1) by Lugano 2014 criteria

    Measured: From Day 1 to 1 year after cell infusion

  3. Pharmacokinetics of GF- CART01-Cmax

    Measure the peak exposure (Cmax) of GF-CART01 after cell infusion

    Measured: From Day 1 to 1 year after cell infusion

  4. Pharmacokinetics of GF- CART01-Tmax

    Measure the time to reach peak exposure (Tmax) of GF-CART01 after cell infusion

    Measured: From Day 1 to 1 year after cell infusion

  5. Pharmacokinetics of GF- CART01-pAUC

    Measure the partial area under the curve (pAUC) of GF-CART01 after cell infusion

    Measured: From Day 1 to 1 year after cell infusion

  6. Pharmacokinetics of GF- CART01-Clast

    Measure the last observed measurable concentration of GF-CART01 after cell infusion

    Measured: From Day 1 to 1 year after cell infusion

  7. Pharmacokinetics of GF- CART01-T1/2

    Measure the time required for concentration of GF-CART01 to decrease by 50% after cell infusion

    Measured: From Day 1 to 1 year after cell infusion

  8. GF-CART01 persistence

    Measure the duration of GF-CART01 presence after cell infusion

    • Time of Clast

    Measured: From Day 1 to 1 year after cell infusion

  9. Feasibility of GF-CART01 production

    Measure the rate of successful GF-CART01 manufacture at Visit 4 (Day 1)

    • Percentage of GF-CART01 products successfully meeting manufacturing criteria

    Measured: From leukapheresis to Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2024
  2. Study start9 Jun 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06703892
Sponsor's protocol ID
GF-01-01
Acronym
CD20/19 CAR T
Status last verified
Dec 2025
First submitted
20 Nov 2024
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GF-CART01 in people with Diffuse Large B Cell Lymphoma Relapsed and Diffuse Large B Cell Lymphoma Refractory, 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 15 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 12 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Howard Cheng (+886-2-2655-8766, howardcheng@genomefrontier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: From Day 1 to 28 days after cell infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06703892.

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 12 Jun 2026.

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