Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT06703892

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

Led by GenomeFrontier Therapeutics TW Co., Ltd. · Updated on 2025-12-22

18

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official 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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 70 years
  • Signed informed consent
  • Histologically confirmed diagnosis of DLBCL-NOS, follicular lymphoma, PMBCL, or HGBCL per WHO 2022 criteria
  • Tumor cells expressing CD19 and/or CD20
  • Relapsed, progressive, or refractory disease after at least two systemic therapies including anti-CD20 antibody and anthracycline, or after auto-HSCT
  • Presence of accessible PET-positive or measurable CT-positive lesions
  • Adequate hematologic function: 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 renal function: eGFR ≥ 60 mL/min/1.73m2
  • Adequate cardiac function: LVEF ≥ 50%, no significant ECG abnormalities
  • Adequate pulmonary function: no active lung infection, oxygen saturation ≥ 92%
  • No clinically significant pleural effusion
  • Estimated survival ≥ 3 months
  • ECOG performance status 0 to 2
  • Willingness and ability to comply with study requirements
Not Eligible

You will not qualify if you...

  • Previous treatment with any CAR T cell product or allogenic HSCT
  • Allergy or intolerance to any investigational product ingredients
  • Known or suspected risk with contrast agents for PET or CT scans
  • Use of other investigational products, cell or gene therapy 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
  • Receipt of live vaccine within 2 weeks before leukapheresis
  • Positive for HIV, syphilis, hepatitis B or C infections
  • Atrial or ventricular involvement by B-cell malignancies
  • Tumor mass requiring urgent treatment within 8 weeks before leukapheresis
  • Severe or uncontrolled diseases including heart conditions, hypertension, or thromboembolism within 6 weeks before leukapheresis
  • History of neurological or autoimmune diseases affecting the CNS
  • Female subjects of childbearing potential who are pregnant or lactating
  • Refusal to use acceptable birth control methods from consent to 12 months post-infusion
  • Severe active infections, CNS involvement by lymphoma, brain metastasis, uncontrolled malignancies, toxicities from prior therapy, or other illnesses deemed unsuitable by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

H

Howard Cheng

CONTACT

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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