OncoMatch

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.

Phase 1RecruitingGenomeFrontier Therapeutics TW Co., Ltd.NCT06703892Data as of Jun 2026Location: Taiwan

Treatment: GF-CART01 · GF-CART01 · GF-CART01This 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 qualify

Extracted eligibility criteria

Treatments studied

Other

GF-CART01GF-CART01GF-CART01

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

Ages ≤ 70

Prior therapy

Min 2 prior lines

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.

Check if I qualify