RecruitingPhase 1NCT06703892

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

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


Sponsor

GenomeFrontier Therapeutics TW Co., Ltd.

Enrollment

18 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

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 (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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called GF-CART01, which targets two proteins (CD19 and CD20) on cancer cells, in people with relapsed or treatment-resistant B-cell blood cancers — including diffuse large B-cell lymphoma and follicular lymphoma. **You may be eligible if...** - You are between 18 and 70 years old - You have confirmed B-cell lymphoma (DLBCL, follicular lymphoma, PMBCL, or high-grade B-cell lymphoma) whose cancer cells test positive for CD19 and/or CD20 - Your cancer has come back or not responded to at least two prior treatment regimens (including an anti-CD20 antibody and chemotherapy), or came back after a stem cell transplant - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have a different type of cancer at the same time (with limited exceptions) - Your heart, liver, or kidney function is significantly impaired - You received another experimental drug within the past 28 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGF-CART01

CAR positive viable T cells-Mid

BIOLOGICALGF-CART01

CAR positive viable T cells-High

BIOLOGICALGF-CART01

CAR positive viable T cells-Low


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06703892


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