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
Recruiting
Phase 1
Interventional Study
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)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 18 (estimated)
- Sponsor
- GenomeFrontier Therapeutics TW Co., Ltd. · Industry
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About This Trial
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-limi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Subjects must be of age ≥ 18 years and ≤ 70 years
2. Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent
3. Histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma - Not Otherwise Specified (DLBCL-NOS), follic…
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