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

An Open, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

This study is testing a new injection treatment called GNC-038 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: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT05623982 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed relapsed or refractory non-Hodgkin's lymphoma who have experienced treatment failure.

Not a fit: Patients with non-Hodgkin's lymphoma who have not undergone at least second-line treatment or those with ECOG scores greater than 2 may not benefit from this study.

Why it matters

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

How similar studies have performed: While this approach is being explored in this trial, similar studies have shown promise in treating relapsed or refractory non-Hodgkin's lymphoma with novel therapies.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 2 other locations

• 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

Conditions Non-hodgkin's Lymphoma