GNC-038 injection for patients with relapsed or refractory non-Hodgkin's lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and preliminary efficacy of GNC-038, an injection treatment, in patients suffering from relapsed or refractory non-Hodgkin's lymphoma (NHL). The study is divided into two phases: Phase Ib focuses on determining the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D), while Phase II assesses the treatment's efficacy. Participants will receive GNC-038 via intravenous infusion once a week for two-week cycles. The trial aims to provide insights into the potential benefits of GNC-038 for this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Harbin First Hospital
  Haerbin, Heilongjing, China Recruiting
• Qingdao Central Hospital
  Qingdao, Shandong, China Recruiting

Study contacts

• Principal investigator: Jun Zhu — Peking University Cancer Hospital & Institute
• Study coordinator: Sa Xiao, PHD
• Email: xiaosa@baili-pharm.com
• Phone: +86-15013238943

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.