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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

NCT06703892 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-12-22

No results posted yet for this study

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

Conditions

  • Diffuse Large B Cell Lymphoma Relapsed
  • Diffuse Large B Cell Lymphoma Refractory
  • Follicular Lymphoma ( FL)
  • Primary Mediastinal Large B-Cell Lymphoma-Refractory
  • Primary Mediastinal Large B-Cell Lymphoma-Recurrent
  • High-grade B-cell Lymphoma (HGBCL)

Interventions

BIOLOGICAL

GF-CART01

CAR positive viable T cells-Mid

BIOLOGICAL

GF-CART01

CAR positive viable T cells-High

BIOLOGICAL

GF-CART01

CAR positive viable T cells-Low

Sponsors & Collaborators

  • GenomeFrontier Therapeutics TW Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2027-03-31
Completion
2027-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06703892 on ClinicalTrials.gov