Actively Recruiting
An Open, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-29
40
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
S
SystImmune Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and early effects of GNC-038, a tetra-specific antibody, in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL). The study aims to find the highest safe dose and recommended phase II dose, or the maximum administered dose and dose-limiting toxicities if the highest safe dose is not reached. This open, multicenter trial includes both phase Ib and phase II parts to evaluate tolerability, pharmacokinetics, and antitumor activity of GNC-038. Participants receive GNC-038 through intravenous infusion once a week, with cycles lasting two weeks. After the first cycle, those who benefit clinically may continue treatment for additional cycles until disease progression, intolerable side effects, or other reasons lead to stopping treatment. The study includes a dose escalation phase followed by an efficacy evaluation phase. Throughout the study, patients undergo evaluations for dose-limiting toxicities, maximum tolerated or administered dose, and adverse events up to about 24 months. Researchers also measure disease control rate, progression-free survival, pharmacokinetics, and immune response to the drug. Ongoing assessments include regular visits, laboratory tests, and monitoring for safety and treatment response during and after treatment.
CONDITIONS
Brief Title
A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable of understanding and voluntarily signing informed consent
- No gender restrictions
- Age between 18 and 75 years
- Expected survival time of at least 3 months
- Histologically confirmed non-Hodgkin's lymphoma
- Relapsed or refractory non-Hodgkin's lymphoma
- Measurable lesions present (lymph node 1.5 cm or extranodal 1.0 cm)
- ECOG performance status score of 2 or less
- Prior anti-tumor treatment side effects recovered to Grade 1 or less
- Organ function meets study requirements before first dose
- Use of effective contraception from 7 days before first dose to 12 weeks after treatment
- Negative pregnancy test within 7 days before first dose for females of childbearing potential
- Willingness and ability to comply with study visits and procedures
You will not qualify if you...
- Pulmonary disease Grade 3 or higher or diagnosed interstitial lung disease
- Active infections needing systemic treatment
- Active tuberculosis
- Active autoimmune diseases
- History of other cancers within 5 years
- Positive for certain hepatitis or HIV markers with detectable viral levels
- Poorly controlled high blood pressure
- History of severe heart or brain blood vessel diseases
- Hypersensitivity to study drug or its components
- Pregnant or breastfeeding women
- Central nervous system involvement
- Major surgery within 28 days before first dose or planned during study
- Prior organ or allogeneic stem cell transplant
- Autologous stem cell transplant within 12 weeks before treatment
- Current use of immunosuppressive therapy
- Radiotherapy within 4 weeks before treatment
- Chemotherapy or targeted therapy within 2 weeks or 5 half-lives before treatment
- CAR-T therapy within 12 weeks before treatment
- Use of other investigational drugs within 4 weeks or 5 half-lives before first dose
- Any other condition making participation unsuitable per investigator judgment
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 2-week cycles until disease progression or discontinuation
Participants receive GNC-038 by intravenous infusion once a week in 2-week cycles. Treatment continues until disease progression, intolerable toxicity, or other reasons for stopping.
Weekly visits for infusion
Duration - Up to approximately 24 months
Participants are monitored for safety and efficacy for up to approximately 24 months after starting treatment.
Periodic visits for monitoring
Trial Site Locations
Total: 3 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Harbin First Hospital
Haerbin, Heilongjing, China
Actively Recruiting
3
Qingdao Central Hospital
Qingdao, Shandong, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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