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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06703892 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR T cell product, allogenic hematopoietic stem cell transplant, investigational product, cell therapy, or gene therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive expression is a required biomarker for enrollment.
Does this trial require CD20?
Yes, CD20 positive expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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