OncoMatch/Clinical Trials/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
Is NCT06703892 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including GF-CART01 and GF-CART01 for diffuse large b cell lymphoma relapsed.
Treatment: GF-CART01 · GF-CART01 · GF-CART01 — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive expression (positive)
Required: CD20 positive expression (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-CD20 antibody
after ≥ two lines of systemic therapy, including anti-CD20 antibody and anthracycline
Must have received: anthracycline
after ≥ two lines of systemic therapy, including anti-CD20 antibody and anthracycline
Cannot have received: CAR T cell product
Previously treated with any CAR T cell product
Cannot have received: allogenic hematopoietic stem cell transplant
Previously treated with ... allogenic hematopoietic stem cell transplant (HSCT)
Cannot have received: investigational product, cell therapy, or gene therapy
Received any other investigational product, cell therapy, or gene therapy within 12 weeks prior to the leukapheresis
Cannot have received: tyrosine kinase inhibitor
Received any tyrosine kinase inhibitor within 2 weeks prior to the leukapheresis
Cannot have received: systemic steroid
Received any systemic steroid ... within 4 weeks prior to the leukapheresis
Cannot have received: immunotherapy (immune checkpoint inhibitors, T-cell transfer therapies, monoclonal antibodies)
Received any ... immunotherapy (such as immune checkpoint inhibitors, T-cell transfer therapies, monoclonal antibodies) ... within 4 weeks prior to the leukapheresis
Cannot have received: chemotherapy
Received any ... chemotherapy within 4 weeks prior to the leukapheresis
Cannot have received: live vaccine
Received any live vaccine from 2 weeks prior to the leukapheresis
Lab requirements
Blood counts
ANC > 1,000/μL, ALC > 300/μL, platelet count ≥ 75,000/μL, hemoglobin ≥ 8.0 g/dL
Kidney function
eGFR ≥ 60 mL/min/1.73m2 (MDRD equation)
Liver function
ALT ≤ 5x ULN, AST ≤ 5x ULN, total bilirubin ≤ 1.5x ULN
Cardiac function
LVEF ≥ 50%; no clinically significant ECG findings
Adequate hematologic function: absolute neutrophil count (ANC) > 1,000/μL, absolute lymphocyte count (ALC) > 300/μL, platelet count ≥ 75,000/μL, hemoglobin ≥ 8.0 g/dL; Adequate hepatic function: ALT ≤ 5x ULN, AST ≤ 5x ULN, total bilirubin ≤ 1.5x ULN; Adequate renal function: eGFR ≥ 60 mL/min/1.73m2 (MDRD equation); Adequate cardiac function: LVEF ≥ 50%; no clinically significant ECG findings
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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