Actively Recruiting
An Open, Multicenter, Phase I/II Trial to Evaluate the Safety and Antitumor Activity of GNC-035 Injection in Relapsed or Refractory Non-Hodgkin's Lymphoma and Other Hematological Malignancies
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-10-01
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating GNC-035, a tetra-specific antibody injection, in patients with relapsed or refractory non-Hodgkin's lymphoma and other blood cancers. The study aims to observe the safety and initial effectiveness of GNC-035 in Phase I, determining the appropriate dose levels and recommended dose for Phase II. Phase II focuses on exploring the drug's effectiveness in this patient population to better understand its potential benefits. Participants receive GNC-035 through an intravenous infusion lasting 2 to 4 hours, given once a week in cycles of three weeks. Those who benefit from the treatment may continue receiving additional cycles. Treatment will stop if the disease progresses, side effects become intolerable, or other reasons occur. The study is open-label and multicenter, with no placebo or blinding. During the trial, participants will be closely monitored for dose limiting toxicities, treatment side effects, and response to the drug using criteria such as objective response rate and progression-free survival. Various laboratory tests and assessments will be conducted up to 24 months after the first dose to evaluate safety, pharmacokinetics, and anti-tumor activity. Participants must comply with scheduled visits and procedures throughout the study period, which could last up to two years or more depending on treatment continuation.
CONDITIONS
Brief Title
A Study of GNC-035 in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent
- No gender restrictions
- Aged 18 to 75 years
- Expected survival time of at least 3 months
- Histologically or cytologically confirmed relapsed or refractory non-Hodgkin's lymphoma
- Failed at least one line of standard therapy or no other suitable treatment options
- At least one measurable lesion meeting Lugano response criteria
- ECOG performance status score of 2 or less
- Recovery from prior anti-tumor therapy toxicities to Grade 1 or lower
- Organ function within required limits before first dose
- Use of effective contraception for participants of childbearing potential
- Willing and able to comply with study visits, treatments, and tests
You will not qualify if you...
- Major surgery within 28 days before study or planned during study
- Pulmonary diseases Grade 3 or higher
- Active infections needing systemic treatment
- Active autoimmune diseases
- History of other cancers within 5 years
- Positive for HIV, active tuberculosis, HBV, or HCV
- Poorly controlled high blood pressure despite medication
- History of severe heart or brain diseases
- Hypersensitivity to humanized antibodies or GNC-035 components
- Pregnant or breastfeeding women
- Central nervous system involvement
- Previous organ or allogeneic stem cell transplant
- Autologous stem cell transplant within 12 weeks before treatment
- Current immunosuppressive therapy
- Recent radiotherapy or targeted therapy within specified timeframes
- Recent anti-CD20 or anti-CD79b treatment with ongoing response
- CAR-T therapy within 12 weeks before treatment
- Use of investigational drugs within 4 weeks before study
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive GNC-035 by intravenous infusion once a week for 3 weeks per cycle. Participants with clinical benefit may receive additional cycles until disease progression or intolerable toxicity.
Weekly visits for infusion during each 3-week cycle
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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