Testing GNC-035 for patients with relapsed or refractory Non-Hodgkin's Lymphoma

An Open, Multicenter, Phase I / II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics / Pharmacodynamics and Antitumor Activity of GNC-035 Tetra-specific Antibody Injection in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies

This study is testing a new treatment called GNC-035 to see if it can help people with relapsed or hard-to-treat Non-Hodgkin's Lymphoma feel better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T, chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06066203 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and preliminary efficacy of GNC-035 in patients suffering from relapsed or refractory non-Hodgkin lymphoma and other hematological malignancies. The study is divided into two phases: Phase I focuses on determining the maximum tolerated dose and dose-limiting toxicity, while Phase II aims to explore the treatment's efficacy. Participants will receive GNC-035 and will be monitored for their response to the treatment. The trial seeks to provide new therapeutic options for patients who have not responded to standard therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed relapsed or refractory non-Hodgkin lymphoma who have failed at least one line of standard therapy.

Not a fit: Patients who are not diagnosed with non-Hodgkin lymphoma or those who have not received prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for patients with difficult-to-treat forms of non-Hodgkin lymphoma.

How similar studies have performed: Other studies have shown promise with similar approaches in treating hematological malignancies, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. The subject is able to understand 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. Histologically or cytologically confirmed relapsed or refractory non-Hodgkin's lymphoma;
6. For patients with relapsed or refractory non-Hodgkin's lymphoma, specifically including: Patients who have failed at least one line of standard therapy; Patients with relapsed or refractory disease judged by the investigator to have no other available or suitable treatment options;
7. For non-Hodgkin's lymphoma, at least one measurable lesion meeting the Lugano response criteria must be present during the screening period;
8. ECOG performance status score ≤2;
9. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
10. Organ function levels meet the requirements within 7 days 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 the last dose. 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. 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);
2. Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0;
3. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
4. Patients with active autoimmune diseases;
5. History of other malignancies within 5 years prior to the first dose;
6. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection;
7. Poorly controlled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg) despite medication;
8. History of severe cardiovascular or cerebrovascular diseases;
9. Patients with a history of hypersensitivity to recombinant humanized antibodies or any excipients of GNC-035;
10. Pregnant or lactating women;
11. Patients with central nervous system involvement;
12. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
13. Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before initiating GNC-035 treatment;
14. Current use of immunosuppressive therapy;
15. Radiotherapy or macromolecular targeted therapy within 4 weeks before initiating GNC-035 treatment; chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is shorter) before treatment;
16. Anti-CD20 or anti-CD79b treatment within 4 weeks before initiating GNC-035 treatment with ongoing response;
17. CAR-T therapy within 12 weeks before initiating GNC-035 treatment;
18. Use of investigational drugs from other clinical trials within 4 weeks or 5 half-lives (whichever is shorter) before the administration of this study;
19. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jun Zhu, PHD — Peking University Cancer Hospital & Institute
• Study coordinator: Sa Xiao, PHD

Conditions Non-hodgkin's Lymphoma; Hematological malignancies