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
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. The subject is capable of understanding the informed consent form, voluntarily participates, and signs the informed consent form;
2. No gender restrictions;
3. Age: ≥18 years and ≤75 years;
4. Expected survival time ≥3 months;
5. Patients with histologically confirmed non-Hodgkin's lymphoma;
6. Patients with relapsed or refractory non-Hodgkin's lymphoma (R/R NHL);
7. Presence of measurable lesions during the screening period (lymph node lesions with any long diameter ≥1.5 cm or extranodal lesions with any long diameter \>1.0 cm);
8. ECOG performance status score ≤2;
9. Adverse reactions from prior anti-tumor treatment have recovered to ≤Grade 1 as per CTCAE 5.0 criteria;
10. Organ function levels meet the requirements before the first dose;
11. Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 12 weeks after treatment discontinuation. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose;
12. The subject has the ability and willingness to comply with the study protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.
Exclusion Criteria:
1. Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0; patients currently diagnosed with interstitial lung disease (ILD);
2. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
3. Active tuberculosis;
4. Patients with active autoimmune diseases;
5. History of other malignancies within 5 years prior to the first dose;
6. HBsAg-positive and/or HBcAb-positive with HBV-DNA levels ≥ the lower limit of detection; HCV antibody-positive with HCV-RNA levels ≥ the lower limit of detection; HIV antibody-positive;
7. Poorly controlled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg);
8. History of severe cardiovascular or cerebrovascular diseases;
9. Patients with a history of hypersensitivity to recombinant humanized antibodies or any excipients of GNC-038;
10. Pregnant or lactating women;
11. Patients with central nervous system involvement;
12. Major surgery within 28 days before the first dose of this study or planned major surgery during the study period;
13. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
14. Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before initiating GNC-038 treatment;
15. Current use of immunosuppressive therapy;
16. Radiotherapy within 4 weeks before initiating GNC-038 treatment;
17. Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives prior to treatment;
18. CAR-T therapy within 12 weeks before initiating GNC-038 treatment;
19. Use of any other investigational drug in a clinical trial within 4 weeks or 5 half-lives before the first dose of this study;
20. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.
Primary outcome measure(s)
Dose limiting toxicity (DLT) — Up to 14 days after the first dose 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) — Up to 14 days after the first dose 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) — Up to approximately 24 months 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) — Up to 14 days after the first dose 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.
Trial sites (3)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
Beijing Municipality
Recruiting
Harbin First Hospital
Haerbin
Heilongjing
Recruiting
Qingdao Central Hospital
Qingdao
Shandong
Recruiting
More Sichuan Baili Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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