Actively Recruiting
A Study of 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
270 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
To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2D of GNC-038, or the MAD and DLT
CONDITIONS
Official 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...
- 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 confirmed non-Hodgkin's lymphoma
- Relapsed or refractory non-Hodgkin's lymphoma
- Measurable lesions during screening (lymph node lesions ≥1.5 cm or extranodal lesions >1.0 cm)
- ECOG performance status score of 2 or less
- Prior anti-tumor treatment side effects recovered to Grade 1 or less per CTCAE 5.0
- Adequate organ function before first dose
- Use of effective contraception for females of childbearing potential and males with partners of childbearing potential from 7 days before first dose until 12 weeks after treatment ends
- Negative pregnancy test within 7 days before first dose for females of childbearing potential
- Willingness and ability to comply with study visits, treatment, tests, and procedures
You will not qualify if you...
- Pulmonary diseases Grade 3 or higher; current interstitial lung disease
- Active infections needing systemic treatment (e.g., severe pneumonia, bacteremia, sepsis)
- Active tuberculosis
- Active autoimmune diseases
- Other malignancies within 5 years before first dose
- Positive for hepatitis B or C with detectable viral levels; HIV positive
- Poorly controlled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
- History of severe heart or brain vascular diseases
- Hypersensitivity to recombinant humanized antibodies or GNC-038 components
- Pregnant or lactating women
- Central nervous system involvement
- Major surgery within 28 days before first dose or planned during study
- Previous organ transplant or allogeneic stem cell transplant
- Autologous stem cell transplant within 12 weeks before starting treatment
- Current immunosuppressive therapy
- Radiotherapy within 4 weeks before starting treatment
- Chemotherapy or targeted therapy within 2 weeks or 5 half-lives before treatment
- CAR-T therapy within 12 weeks before starting treatment
- Use of other investigational drugs within 4 weeks or 5 half-lives before first dose
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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