Actively Recruiting
An Open-Label, Non-Randomized, Phase I Dose-Finding Study to Evaluate the Safety and Clinical Activity of GF-CART01 (CD20/19 CAR T Cell) in Relapsed or Refractory B-Cell Hematological Malignancies
Led by GenomeFrontier Therapeutics TW Co., Ltd. · Updated on 2025-12-22
18
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating GF-CART01, a CD20/19 CAR T cell therapy, in adults aged 18 to 70 years who have relapsed or refractory B-cell blood cancers. This Phase I study aims to find the safest dose and understand how well the treatment persists and works in patients who have failed at least two previous standard chemotherapy treatments or autologous stem cell transplantation. The trial follows a traditional dose-escalation design to identify dose-limiting toxicities and recommend doses for future studies. Participants receive GF-CART01, which involves giving live CAR-positive T cells targeting cancer cells. The study tests three dose levels: low, mid, and high. The treatment is given once, followed by monitoring for safety and clinical effects. Researchers will observe patients closely from the time of cell infusion through one year post-infusion to assess safety, tolerability, and clinical responses. The study is non-randomized and open-label, meaning all participants receive the investigational therapy. During the study, participants will have blood tests, imaging scans, and clinical exams to measure the treatment's activity, persistence, and side effects. Researchers will evaluate maximum tolerated dose and safety from the infusion day up to one year. They will also track pharmacokinetics, tumor response rates, and production feasibility of the CAR T cells. The total study duration per participant includes screening, treatment, and follow-up visits over at least one year to gather comprehensive safety and efficacy data.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Legal consent given by participant or guardian
- Confirmed diagnosis of DLBCL-NOS, follicular lymphoma, PMBCL, or high-grade B-cell lymphoma by WHO 2022 criteria
- Tumor cells express CD19 and/or CD20
- Relapsed, progressive, or refractory disease after at least two systemic therapies including anti-CD20 and anthracycline or after autologous HSCT
- Presence of accessible PET-positive or measurable CT-positive lesion
- Adequate blood counts: ANC > 1,000/µL, ALC > 300/µL, platelets ≥ 75,000/µL, hemoglobin ≥ 8.0 g/dL
- Adequate liver function: ALT and AST ≤ 5 times ULN, total bilirubin ≤ 1.5 times ULN
- Adequate kidney function: eGFR ≥ 60 mL/min/1.73m2
- Adequate heart function: LVEF ≥ 50% and no significant ECG abnormalities
- Adequate lung function: no active lung infection, oxygen saturation ≥ 92%
- No clinically significant pleural effusion
- Estimated survival time ≥ 3 months
- ECOG performance status 0 to 2
- Willingness and ability to follow study procedures
You will not qualify if you...
- Prior treatment with any CAR T cell product or allogeneic HSCT
- Allergy or intolerance to investigational product ingredients
- Known risk or history of reaction to PET or CT contrast agents
- Use of investigational products, cell or gene therapies within 12 weeks before leukapheresis
- Use of tyrosine kinase inhibitors within 2 weeks before leukapheresis
- Use of systemic steroids, immunotherapy, or chemotherapy within 4 weeks before leukapheresis
- Live vaccine received within 2 weeks before leukapheresis
- Positive tests for HIV, syphilis, hepatitis B or C
- B-cell malignancy involvement in atria or ventricles
- Tumor mass requiring urgent treatment within 8 weeks before leukapheresis
- Severe or uncontrolled diseases including serious heart conditions or uncontrolled hypertension
- Recent major thromboembolism within 6 weeks before leukapheresis
- History of significant neurological or autoimmune diseases with CNS involvement
- Female participants who are pregnant or breastfeeding
- Participants not agreeing to birth control requirements from consent to 12 months after infusion
- Any severe active infection except simple urinary tract infections or bacterial pharyngitis
- Active CNS lymphoma involvement or malignant cells in cerebrospinal fluid
- History of brain metastasis or uncontrolled malignancies
- Toxicities from prior therapy or uncontrolled illnesses as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Day 1 to 28 days after cell infusion
Participants receive the GF-CART01 CAR T cell therapy to evaluate its safety and clinical activity.
Multiple visits during the first 28 days post-infusion for monitoring
Duration - From Day 1 to 1 year after cell infusion
Participants are monitored for safety, efficacy, and persistence of GF-CART01 up to 1 year after cell infusion.
Regular follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
H
Howard Cheng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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