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
The subject is capable of understanding 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;
Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0; patients currently diagnosed with interstitial lung disease (ILD);
Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
Active tuberculosis;
Patients with active autoimmune diseases;
Sequential
GNC-038
DrugAdministration by intravenous infusion
Dose limiting toxicity (DLT)
The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).
Maximum tolerated dose (MTD) or Maximum dose (MAD)
In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.
Adverse Events during Treatment (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of GNC-038. The type, frequency and severity of TEAE will be evaluated during the treatment of GNC-038.
Recommended dose for Phase II clinical studies (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of GNC-038.
disease control rate (DCR)
Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response.
progression-free survival (PFS)
The PFS is defined as the time from the participant's first dose of GNC-038 to the first date of either disease progression or death, whichever occurs first.
Adverse Events of Special Interest (AESI)
AESI is an event of scientific and medical interest specific to the sponsor's product or research project.
Cmax
Maximum serum concentration (Cmax) of GNC-038 will be investigated.
Neutralizing antibody (Nab) in phase Ⅰb
Incidence and titer of Nab of GNC-038 will be evaluated.
Overall survival (OS) in phaseⅠb and phase Ⅱ
The time between the start of study medication and death.
Neutralizing antibody (Nab) in phaseⅡ
Incidence and titer of Nab of GNC-038 will be evaluated.
anti-drug antibody (ADA) in phaseⅡ
Frequency and titer of anti-GNC-038 antibody (ADA) will be evaluated.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
SystImmune Inc.
Collaborator
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
