A Study of GNC-035 in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

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

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator