Actively Recruiting
A Study of GNC-035 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
213 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
Phase I main objectives: To observe the safety and preliminary efficacy of GNC-035 in patients with relapsed/refractory non-Hodgkin lymphoma and other hematological malignancies, to determine the DLT and MTD, or MAD, and to determine RP2D. Phase II Main objective: To explore the efficacy of GNC-035 in patients with relapsed/refractory non-Hodgkin lymphoma and other hematological malignancies.
CONDITIONS
Official 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
- Age between 18 and 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 0 to 2
- Toxicity from prior therapies recovered to Grade 1 or less
- Organ function meeting study requirements within 7 days before first dose
- Use of effective contraception for those of childbearing potential from 7 days before first dose until 12 weeks after last dose
- Negative pregnancy test within 7 days before first dose for females of childbearing potential
- Willingness and ability to comply with study visits, treatment, and tests
You will not qualify if you...
- Major surgery within 28 days before study or planned during study
- Pulmonary diseases at Grade 3 or higher
- Active infections requiring systemic treatment like severe pneumonia or sepsis
- Active autoimmune diseases
- History of other cancers within 5 years
- Positive for HIV antibodies, active tuberculosis, active hepatitis B or C infections
- Poorly controlled hypertension despite medication
- Severe cardiovascular or cerebrovascular disease history
- Hypersensitivity to recombinant humanized antibodies or GNC-035 components
- Pregnant or breastfeeding women
- Central nervous system involvement
- Previous organ transplantation or allogeneic stem cell transplant
- Autologous stem cell transplant within 12 weeks before treatment
- Current use of immunosuppressive therapy
- Recent radiotherapy, macromolecular targeted therapy, chemotherapy, or small-molecule targeted therapy within specified time frames
- 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 or 5 half-lives before study
- Any other condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
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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