About this trial
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.
Eligibility criteria
Qualifiers
The subject is able to understand the informed consent form, voluntarily participates, and signs the informed consent form;
No gender restrictions;
Age: ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Disqualifiers
Patients who have undergone major surgery within 28 days prior to the administration of this study or are scheduled for major surgery during the study period (major surgery is defined by the investigator);
Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0;
Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
Patients with active autoimmune diseases;
Trial design
Treatments tested in this trial
- GNC-035
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator