Actively Recruiting
GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL
Led by The First Affiliated Hospital of Xiamen University · Updated on 2026-03-13
45
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
CONDITIONS
Official Title
GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to communicate effectively and provide written informed consent
- Age between 18 and 70 years, any gender
- Confirmed diagnosis of non-Hodgkin lymphoma by cytology and genetics
- Tumor cells show positive CD19 expression by flow cytometry or pathology
- Relapsed or refractory disease after at least second-line systemic therapy including rituximab or similar and anthracycline drugs, or refusal of chemotherapy but strong desire for CAR-T treatment
- No evidence of central nervous system lymphoma on brain MRI
- Blood counts: neutrophils ≥ 1.0 x 10^9/L; hemoglobin ≥ 70 g/L; platelets ≥ 50 x 10^9/L
- Coagulation: fibrinogen ≥ 1.0 g/L; APTT ≤ ULN+10 seconds; PT ≤ ULN+3 seconds
- Liver and kidney function within acceptable limits (bilirubin ≤ 1.5x ULN, ALT and AST ≤ 3x ULN, creatinine ≤ 2x ULN), unless due to tumor infiltration
- Left ventricular ejection fraction ≥ 45% by echocardiography or radionuclide scan
- Pulmonary function: dyspnea grade ≤ 1 and oxygen saturation ≥ 92% in room air
- Eastern Cooperative Oncology Group (ECOG) physical fitness score 0 to 2
- Expected survival longer than 6 months
- Sufficient functional organ levels at screening
- Female participants of childbearing potential must have negative pregnancy test before treatment and agree to use reliable contraception for one year after treatment
- Male participants active sexually with women of reproductive potential must agree to use reliable contraception for one year after treatment and not donate sperm during this time
You will not qualify if you...
- History of allergy to serum albumin or DMSO
- Active hepatitis B (HBV-DNA positive), hepatitis C (HCV-RNA positive), or HIV infection
- Terminal organ damage from autoimmune diseases or need for systemic immunosuppressive treatments within past 2 years
- History of unstable angina, heart attack, coronary angioplasty, or significant heart disease within one year
- Primary central nervous system tumors or lymphoma with CNS metastases
- Uncontrolled mental illness
- Severe life-threatening organ failure
- Participation in other clinical trials within past 4 weeks
- Live vaccination within 4 weeks before enrollment
- Use of prohibited drugs such as high-dose corticosteroids within 7 days before leukocyte collection, recent chemotherapy or donor lymphocyte infusion, recent anti-GvHD treatments, or checkpoint inhibitors before enrollment
- History of lung injury or hemorrhagic cystitis related to cyclophosphamide treatment
- Pregnancy, planning pregnancy, or breastfeeding
- Unlikely to complete all required study visits or procedures or insufficient compliance as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Bing Xu
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
B
Bing Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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